Trial Outcomes & Findings for An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis (NCT NCT01772823)

NCT ID: NCT01772823

Last Updated: 2018-01-17

Results Overview

This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints. Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey: "During the past month, how many male partners have you had sexual contact with (oral or anal)?" (Baseline), or "Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?" (Week 48) And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey: "Of those you had unprotected sex with, how many did you know were HIV positive?"

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 200 participants
• Primary outcome timeframe: Baseline and 48 weeks
• Results posted on: 2018-01-17

Participant Flow

This research was conducted at 12 clinical sites. Accrual was open between July 2012 and September 2013.

Participant milestones

Measure	3MV Behavioral Intervention Group 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Behavioral Intervention (BL -3MV or PCC) STARTED	128	72
Behavioral Intervention (BL -3MV or PCC) COMPLETED	116	70
Behavioral Intervention (BL -3MV or PCC) NOT COMPLETED	12	2
Treatment Phase (Week 0- Week 48) STARTED	116	70
Treatment Phase (Week 0- Week 48) COMPLETED	88	52
Treatment Phase (Week 0- Week 48) NOT COMPLETED	28	18
Extension Phase (Visits 24,48wks Post tx STARTED	63	42
Extension Phase (Visits 24,48wks Post tx COMPLETED	53	33
Extension Phase (Visits 24,48wks Post tx NOT COMPLETED	10	9

Reasons for withdrawal

Measure	3MV Behavioral Intervention Group 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Behavioral Intervention (BL -3MV or PCC) Lost to Follow-up	1	0
Behavioral Intervention (BL -3MV or PCC) Withdrawal by Subject	1	1
Behavioral Intervention (BL -3MV or PCC) Inadvertent enrollment	1	0
Behavioral Intervention (BL -3MV or PCC) Inelligible at rescreen	2	1
Behavioral Intervention (BL -3MV or PCC) Wk 0 not completed, 30 days of baseline	6	0
Behavioral Intervention (BL -3MV or PCC) Moved out of area	1	0
Treatment Phase (Week 0- Week 48) Lost to Follow-up	15	13
Treatment Phase (Week 0- Week 48) Withdrawal by Subject	6	1
Treatment Phase (Week 0- Week 48) Moved out of area	4	3
Treatment Phase (Week 0- Week 48) Incarcerated	1	0
Treatment Phase (Week 0- Week 48) Suicide gesture/disruptive behavior	1	0
Treatment Phase (Week 0- Week 48) Wk 0 not completed, 30 days of baseline	1	1
Extension Phase (Visits 24,48wks Post tx Lost to Follow-up	6	5
Extension Phase (Visits 24,48wks Post tx Withdrawal by Subject	1	2
Extension Phase (Visits 24,48wks Post tx Moved out of area	2	2
Extension Phase (Visits 24,48wks Post tx Became unavailable for study visits	1	0

Baseline Characteristics

An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis

Baseline characteristics by cohort

Measure	3MV Behavioral Intervention Group n=128 Participants 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.	PCC Behavioral Intervention Group n=72 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.	Total n=200 Participants Total of all reporting groups
Age, Continuous	20.14 years STANDARD_DEVIATION 1.40 • n=5 Participants	20.25 years STANDARD_DEVIATION 1.23 • n=7 Participants	20.18 years STANDARD_DEVIATION 1.34 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	128 Participants n=5 Participants	72 Participants n=7 Participants	200 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Asian/Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Black/African American	55 Participants n=5 Participants	38 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · White	26 Participants n=5 Participants	16 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · White/Hispanic	15 Participants n=5 Participants	6 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Other/Mixed Race	30 Participants n=5 Participants	12 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Ethnicity · Hispanic	39 Participants n=5 Participants	14 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Ethnicity · Non-Hispanic	89 Participants n=5 Participants	56 Participants n=7 Participants	145 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic Ethnicity · Refused	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	128 Participants n=5 Participants	72 Participants n=7 Participants	200 Participants n=5 Participants
BMI Underweight (<18.5 kg/m^2)	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
BMI Normal (18.5-<25 kg/m^2)	71 Participants n=5 Participants	38 Participants n=7 Participants	109 Participants n=5 Participants
BMI Overweight (25.0-<30 kg/m^2)	25 Participants n=5 Participants	18 Participants n=7 Participants	43 Participants n=5 Participants
BMI Obese (=>30 kg/m^2)	29 Participants n=5 Participants	10 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 Weeks

Population: Participants with visit data through 48 weeks. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM

Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal.

Outcome measures

Measure	All Study Participants n=137 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Number of Participants With Serum Creatinine Event of Grade 1 or Higher	1 Participants	—

PRIMARY outcome

Timeframe: 48 weeks

Population: Enrolled subjects with DXA results for Baseline and Week 48 The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM."

The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48.

Outcome measures

Measure	All Study Participants n=135 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 Decrease in absolute BMD >=1%	97 Participants	—
Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 Decrease in absolute BMD >=5%	16 Participants	—
Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48 Decrease in absolute BMD >10%	1 Participants	—

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

Bone mineral density at Baseline and Week 48: data reported below for lumbar spine.

Outcome measures

Measure	All Study Participants n=197 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Lumbar Spine Bone Mineral Density at Baseline and at Week 48 Lumbar spine BMD at baseline	1.09 g/cm2 Standard Deviation 0.15	—
Lumbar Spine Bone Mineral Density at Baseline and at Week 48 Lumbar spine BMD Week 48	1.08 g/cm2 Standard Deviation 0.14	—

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

Bone mineral density at Baseline and Week 48: data reported below for femoral neck.

Outcome measures

Measure	All Study Participants n=197 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Femoral Neck Bone Mineral Density at Baseline and at Week 48 Femoral neck BMD at baseline	1.04 g/cm2 Standard Deviation 0.18	—
Femoral Neck Bone Mineral Density at Baseline and at Week 48 Femoral neck Week 48	1.03 g/cm2 Standard Deviation 0.20	—

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

Bone mineral density at Baseline and Week 48: data reported below for total body.

Outcome measures

Measure	All Study Participants n=197 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Total Body Bone Mineral Density at Baseline and at Week 48 Total body BMD Week 48	1.18 g/cm2 Standard Deviation 0.11	—
Total Body Bone Mineral Density at Baseline and at Week 48 Total body BMD at baseline	1.20 g/cm2 Standard Deviation .011	—

PRIMARY outcome

Timeframe: Baseline, Week 48

Population: Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.

Bone mineral density at Baseline and Week 48: data reported below for total hip.

Outcome measures

Measure	All Study Participants n=197 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Total Hip Bone Mineral Density at Baseline and at Week 48 Total hip BMD at baseline	1.10 g/cm2 Standard Deviation 0.16	—
Total Hip Bone Mineral Density at Baseline and at Week 48 Total hip BMD Week 48	1.08 g/cm2 Standard Deviation 0.17	—

PRIMARY outcome

Timeframe: Baseline and 48 weeks

Population: Participants at Baseline/Week 48 providing a response to this question. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints.

Responses to the participant ACASI question referring to male partners in the past month/since the last survey:

"Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month?" (Baseline), or "Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?" (Week 48) An event is defined as an answer of greater than 0.

Outcome measures

Measure	All Study Participants n=200 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Number of Participants With Unprotected Sex Acts Had unprotected oral/anal w/male (BL)	143 Participants	—
Number of Participants With Unprotected Sex Acts Had unprotected oral/anal w/ male (Wk48)	103 Participants	—

PRIMARY outcome

Timeframe: Baseline and 48 weeks

Population: Participants at Baseline/Week 48 providing a response to this question. The primary objective "Additional safety data regarding FTC/TDF (Truvada®) use" did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective "Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM," specifically behavioral disinhibition/risk compensation endpoints.

Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey:

"During the past month, how many male partners have you had sexual contact with (oral or anal)?" (Baseline), or "Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?" (Week 48)

And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey:

"Of those you had unprotected sex with, how many did you know were HIV positive?"

Outcome measures

Measure	All Study Participants n=200 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Number of Sex Partners Male sexual partners last month (baseline)	5.41 sexual partners Standard Deviation 26.03	—
Number of Sex Partners Male sexual partners since last survey (Wk 48)	2.46 sexual partners Standard Deviation 2.92	—
Number of Sex Partners Number HIV+ male partners last month (baseline)	1.65 sexual partners Standard Deviation 16.77	—
Number of Sex Partners Number HIV+ male partners since last survey(Wk48)	0.15 sexual partners Standard Deviation 0.38	—

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about the size of the pill.

Outcome measures

Measure	All Study Participants n=101 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=61 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill Liked a lot	2 Participants	2 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill Did not like it at all	13 Participants	5 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill Did not like	26 Participants	18 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill Liked	60 Participants	36 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies"

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

This specific outcome focuses on the question of how participants felt about the taste of the pill.

Outcome measures

Measure	All Study Participants n=100 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=61 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill Did not like it at all	11 Participants	8 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill Did not like	33 Participants	23 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill Liked	53 Participants	29 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill Liked a lot	3 Participants	1 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies"

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

This specific outcome focuses on the question of how participants felt about the color of the pill.

Outcome measures

Measure	All Study Participants n=101 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=61 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill Did not like it at all	3 Participants	2 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill Did not like	7 Participants	6 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill Liked	73 Participants	48 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill Liked a lot	18 Participants	5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective: "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies."

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

This specific outcome focuses on the question of how participants felt about taking the pill every day.

Outcome measures

Measure	All Study Participants n=100 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=60 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day Did not like it at all	6 Participants	4 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day Did not like	24 Participants	17 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day Liked	63 Participants	31 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day Liked a lot	7 Participants	8 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective "Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies."

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.

This specific outcome focuses on the question of how participants felt about taking part in the study.

Outcome measures

Measure	All Study Participants n=102 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=61 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study Did not like it at all	1 Participants	1 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study Did not like	2 Participants	1 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study Liked	35 Participants	29 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study Liked a lot	64 Participants	30 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having an HIV test at every visit.

Outcome measures

Measure	All Study Participants n=102 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=61 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit Did not like it at all	1 Participants	0 Participants
Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit Did not like	1 Participants	4 Participants
Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit Liked	29 Participants	15 Participants
Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit Liked a lot	71 Participants	42 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having individual risk reduction counseling at every visit

Outcome measures

Measure	All Study Participants n=102 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=61 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit Did not like it at all	2 Participants	1 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit Did not like	1 Participants	5 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit Liked	38 Participants	23 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit Liked a lot	61 Participants	32 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about being asked questions about sexual behavior at every visit

Outcome measures

Measure	All Study Participants n=101 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=61 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior Did not like it at all	1 Participants	1 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior Did not like	8 Participants	13 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior Liked	61 Participants	31 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior Liked a lot	31 Participants	16 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants enrolled at Week 12 who provided a response to this question.

This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.

Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having a physician exam by a doctor

Outcome measures

Measure	All Study Participants n=101 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=61 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam Did not like it at all	1 Participants	1 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam Did not like	13 Participants	4 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam Liked	54 Participants	38 Participants
Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam Liked a lot	33 Participants	18 Participants

PRIMARY outcome

Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Population: Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective: "Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies."

PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and >1250 fmol per punch (daily).

Outcome measures

Measure	All Study Participants n=200 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 4 · Below level of quantification	13 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 4 · <2 days	35 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 4 · 2 days	58 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 4 · 4 days	59 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 4 · Daily	8 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 8 · Below level of quantification	7 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 8 · <2 days	32 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 8 · 2 days	30 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 8 · 4 days	69 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 8 · Daily	26 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 12 · Below level of quantification	12 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 12 · <2 days	32 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 12 · 2 days	26 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 12 · 4 days	55 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 12 · Daily	34 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 24 · Below level of quantification	28 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 24 · <2 days	36 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 24 · 2 days	14 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 24 · 4 days	42 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 24 · Daily	28 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 36 · Below level of quantification	30 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 36 · <2 days	27 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 36 · 2 days	23 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 36 · 4 days	26 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 36 · Daily	28 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 48 · Below level of quantification	37 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 48 · <2 days	24 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 48 · 2 days	18 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 48 · 4 days	26 Participants	—
Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure Week 48 · Daily	15 Participants	—

PRIMARY outcome

Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Population: Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations.

Outcome measures

Measure	All Study Participants n=200 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC FTC-TP at Week 4	0.20 pmol/punch Standard Deviation 0.11	—
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC FTC-TP at Week 8	0.19 pmol/punch Standard Deviation 0.12	—
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC FTC-TP at Week 12	0.18 pmol/punch Standard Deviation 0.12	—
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC FTC-TP at Week 24	0.16 pmol/punch Standard Deviation 0.12	—
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC FTC-TP at Week 36	0.17 pmol/punch Standard Deviation 0.13	—
Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC FTC-TP at Week 48	0.15 pmol/punch Standard Deviation 0.13	—

PRIMARY outcome

Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48

Population: Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.

This outcome addresses the objective: "Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies."

PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations.

Outcome measures

Measure	All Study Participants n=200 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC TFV-DP at Week 12	793.37 fmol/punch Standard Deviation 548.87	—
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC TFV-DP at Week 4	584.56 fmol/punch Standard Deviation 365.37	—
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC TFV-DP at Week 8	783.18 fmol/punch Standard Deviation 505.67	—
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC TFV-DP at Week 24	657.66 fmol/punch Standard Deviation 619.06	—
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC TFV-DP at Week 36	671.72 fmol/punch Standard Deviation 678.37	—
Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) DBS RBC TFV-DP at Week 48	528.24 fmol/punch Standard Deviation 570.80	—

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 1 of 10: "I learned a lot from this workshop/session"

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=83 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: "I Learned a Lot From This Workshop/Session." Strongly agree	47 Participants	32 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: "I Learned a Lot From This Workshop/Session." Agree	16 Participants	47 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: "I Learned a Lot From This Workshop/Session." Disagree	2 Participants	4 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: "I Learned a Lot From This Workshop/Session." Strongly Disagree	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 2 of 10: "I will be able to apply what I learned from this workshop/session in my life"

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=83 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: "I Will be Able to Apply What I Learned From This Workshop/Session in my Life." Strongly agree	50 Participants	48 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: "I Will be Able to Apply What I Learned From This Workshop/Session in my Life." Agree	13 Participants	34 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: "I Will be Able to Apply What I Learned From This Workshop/Session in my Life." Disagree	2 Participants	1 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: "I Will be Able to Apply What I Learned From This Workshop/Session in my Life." Strongly Disagree	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 3 of 10: "I was given an opportunity to participate and discuss information with others"

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=82 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: "I Was Given an Opportunity to Participate and Discuss Information With Others." Strongly Disagree	3 Participants	2 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: "I Was Given an Opportunity to Participate and Discuss Information With Others." Strongly agree	55 Participants	55 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: "I Was Given an Opportunity to Participate and Discuss Information With Others." Agree	10 Participants	21 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: "I Was Given an Opportunity to Participate and Discuss Information With Others." Disagree	0 Participants	4 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 4 of 10: "The workshop/session was well organized"

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=82 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: "The Workshop/Session Was Well Organized." Strongly Disagree	2 Participants	0 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: "The Workshop/Session Was Well Organized." Strongly agree	49 Participants	66 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: "The Workshop/Session Was Well Organized." Agree	13 Participants	15 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: "The Workshop/Session Was Well Organized." Disagree	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 5 of 10: "The topic of this workshop/session was interesting"

Outcome measures

Measure	All Study Participants n=67 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=82 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: "The Topic of This Workshop/Session Was Interesting." Strongly agree	47 Participants	56 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: "The Topic of This Workshop/Session Was Interesting." Agree	16 Participants	23 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: "The Topic of This Workshop/Session Was Interesting." Disagree	2 Participants	3 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: "The Topic of This Workshop/Session Was Interesting." Strongly Disagree	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 6 of 10: "The presenter(s) stimulated my interest in the material"

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=82 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: "The Presenter(s) Stimulated my Interest in the Material." Strongly agree	50 Participants	54 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: "The Presenter(s) Stimulated my Interest in the Material." Agree	14 Participants	26 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: "The Presenter(s) Stimulated my Interest in the Material." Disagree	1 Participants	2 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: "The Presenter(s) Stimulated my Interest in the Material." Strongly Disagree	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 7 of 10: "The topic of this workshop/session was relevant to my life"

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=83 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: "The Topic of This Workshop/Session Was Relevant to my Life." Strongly agree	50 Participants	65 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: "The Topic of This Workshop/Session Was Relevant to my Life." Agree	13 Participants	17 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: "The Topic of This Workshop/Session Was Relevant to my Life." Disagree	1 Participants	1 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: "The Topic of This Workshop/Session Was Relevant to my Life." Strongly Disagree	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 8 of 10: "The workshop/session was enjoyable."

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=82 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: "The Workshop/Session Was Enjoyable." Strongly agree	47 Participants	49 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: "The Workshop/Session Was Enjoyable." Agree	14 Participants	28 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: "The Workshop/Session Was Enjoyable." Disagree	5 Participants	4 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: "The Workshop/Session Was Enjoyable." Strongly Disagree	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 9 of 10: "I would recommend this workshop/session to others."

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=82 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: "I Would Recommend This Workshop/Session to Others." Strongly agree	49 Participants	47 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: "I Would Recommend This Workshop/Session to Others." Agree	10 Participants	31 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: "I Would Recommend This Workshop/Session to Others." Disagree	6 Participants	4 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: "I Would Recommend This Workshop/Session to Others." Strongly Disagree	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing a response to this question on the Session Evaluation Form

Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).

Item 10 of 10: "I felt comfortable participating in this workshop/session."

Outcome measures

Measure	All Study Participants n=68 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=83 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: "I Felt Comfortable Participating in This Workshop/Session." Agree	9 Participants	23 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: "I Felt Comfortable Participating in This Workshop/Session." Disagree	2 Participants	5 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: "I Felt Comfortable Participating in This Workshop/Session." Strongly Disagree	3 Participants	0 Participants
Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: "I Felt Comfortable Participating in This Workshop/Session." Strongly agree	54 Participants	55 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Enrolled subjects

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's age at enrollment.

Outcome measures

Measure	All Study Participants n=141 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=59 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)	20.28 years Standard Deviation 1.32	19.93 years Standard Deviation 1.36

SECONDARY outcome

Timeframe: 48 weeks

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 weeks

Population: Enrolled subjects

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's race (5 categories)

Outcome measures

Measure	All Study Participants n=141 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=59 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) Asian/Pacific Islander	2 Participants	0 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) Black/African American	71 Participants	22 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) White	25 Participants	17 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) White/Hispanic	15 Participants	6 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories) Other/Mixed Race	28 Participants	14 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Enrolled subjects

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's race (2 categories)

Outcome measures

Measure	All Study Participants n=141 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=59 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories) Black/African-American	84 Participants	25 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories) Non-Black/African-American	57 Participants	34 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Enrolled subjects

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's ethnicity, (Hispanic vs. Non-Hispanic or Latino)

Outcome measures

Measure	All Study Participants n=141 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=59 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) Refused to answer	2 Participants	0 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) Hispanic or Latino	36 Participants	17 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino) Non-Hispanic	103 Participants	42 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Enrolled subjects

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's BMI (kg/m2), assessed categorically.

Outcome measures

Measure	All Study Participants n=141 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=59 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) Underweight (<18.5)	6 Participants	3 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) Normal (18.5- <25)	78 Participants	31 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) Overweight (25.0 - <30)	31 Participants	12 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical) Obese (>=30)	26 Participants	13 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Enrolled subjects

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)

Outcome measures

Measure	All Study Participants n=141 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=59 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)	1.22 copies/ml Standard Deviation 0.60	1.14 copies/ml Standard Deviation 0.15

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants providing ACASI data for these questions

Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.

PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.

This item concerns whether the subject reported any high risk sex acts with a male partner, defined as an answer of greater than 0 to the question "Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?"

Outcome measures

Measure	All Study Participants n=123 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=54 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts) No (no high risk sex acts w/ male partner)	22 Participants	12 Participants
Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts) Yes (Had high risk sex acts w/ male partner)	101 Participants	42 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.

Total number of subjects who signed up for text message reminders

Outcome measures

Measure	All Study Participants n=200 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders	76 Participants	—

SECONDARY outcome

Timeframe: 48 weeks

Population: Total number of subjects signed up for text message reminders This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.

Number of subjects who discontinued receiving text message reminders while they were still on the study agent

Outcome measures

Measure	All Study Participants n=76 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders	3 Participants	—

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Were away from home?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) Never	31 Participants	22 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) Rarely	17 Participants	11 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) Sometimes	19 Participants	10 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home) Often	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Were too busy with other things?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) Never	33 Participants	24 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) Rarely	17 Participants	10 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) Sometimes	14 Participants	11 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things) Often	10 Participants	4 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Simply forgot?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) Never	28 Participants	21 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) Rarely	18 Participants	14 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) Sometimes	18 Participants	9 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot) Often	10 Participants	5 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Had too many study pills to take?"

Outcome measures

Measure	All Study Participants n=73 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) Never	62 Participants	46 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) Rarely	7 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) Sometimes	2 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills) Often	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Wanted to avoid side effects?"

Outcome measures

Measure	All Study Participants n=73 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) Never	64 Participants	42 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) Rarely	7 Participants	4 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) Sometimes	2 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects) Often	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Did not want others to notice you taking meds?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) Never	65 Participants	43 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) Rarely	7 Participants	3 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) Sometimes	1 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice) Often	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Had a change in daily routine?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) Never	51 Participants	31 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) Rarely	9 Participants	5 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) Sometimes	10 Participants	7 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change) Often	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Felt like the study pill was toxic/harmful?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) Rarely	3 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) Sometimes	0 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) Often	0 Participants	2 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful) Never	71 Participants	45 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Fell asleep/slept through dose time?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) Never	52 Participants	35 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) Rarely	13 Participants	6 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) Sometimes	5 Participants	7 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep) Often	4 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Felt sick or ill?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) Never	61 Participants	43 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) Rarely	9 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) Sometimes	3 Participants	4 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill) Often	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Felt depressed/overwhelmed?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) Never	62 Participants	43 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) Rarely	10 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) Sometimes	1 Participants	4 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed) Often	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 weeks

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Ran out of study pills?"

Outcome measures

Measure	All Study Participants n=74 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) Never	67 Participants	44 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) Rarely	7 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) Sometimes	0 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills) Often	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Participants enrolled at Week 48 providing a response to this question.

Subjects were asked to rate various measures as "Never," "Rarely," "Sometimes," or "Often" the reason for missing taking study pills. Data shown for Week 48.

Question: In the past month, how often have you missed taking your study pills because you:

"Didn't think you needed it because you weren't having risk sex?"

Outcome measures

Measure	All Study Participants n=73 Participants Combined data for all participants that participated in either the 3MV or PCC arms/groups as part of the study.	PCC Behavioral Intervention Group n=49 Participants PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) Never	58 Participants	43 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) Rarely	12 Participants	4 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) Sometimes	1 Participants	1 Participants
Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex) Often	2 Participants	1 Participants

Adverse Events

3MV Behavioral Intervention Group

Serious events: 7 serious events

Other events: 10 other events

Deaths: 0 deaths

PCC Behavioral Intervention Group

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	3MV Behavioral Intervention Group n=128 participants at risk 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.	PCC Behavioral Intervention Group n=72 participants at risk PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Immune system disorders Hypersensitivity	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Injury, poisoning and procedural complications Road traffic accident	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Infections and infestations Appendicitis	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Psychiatric disorders Suicide attempt	1.6% 2/128 • Number of events 3 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Psychiatric disorders Post-traumatic stress disorder	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Gastrointestinal disorders Colitis	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/128 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	1.4% 1/72 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Psychiatric disorders Suicidal ideation	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Psychiatric disorders Psychotic disorder	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.

Other adverse events

Measure	3MV Behavioral Intervention Group n=128 participants at risk 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The 3MV intervention was conducted as a 2-day seminar with approximately 10-20 subjects per sessions. After completion of the 3MV intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.	PCC Behavioral Intervention Group n=72 participants at risk PCC is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. The PCC intervention was conducted as a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. After completion of the PCC intervention, all subjects were provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
Gastrointestinal disorders Diarrhoea	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Gastrointestinal disorders Nausea	0.00% 0/128 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	1.4% 1/72 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Immune system disorders Hypersensitivity	1.6% 2/128 • Number of events 2 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	1.4% 1/72 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Infections and infestations Cytomegalovirus Hepatitis	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Infections and infestations Gastroenteritis Shigella	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Injury, poisoning and procedural complications Avulsion Fracture	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Injury, poisoning and procedural complications Head injury	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Investigations Weight decreased	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	1.4% 1/72 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Investigations Alanine Aminotransferase Increased	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Metabolism and nutrition disorders Abnormal loss of weight	1.6% 2/128 • Number of events 2 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Metabolism and nutrition disorders Decreased appetitie	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Metabolism and nutrition disorders Diabetes mellitus	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Musculoskeletal and connective tissue disorders Trigger finger	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Nervous system disorders Headache	0.78% 1/128 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	0.00% 0/72 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.
Reproductive system and breast disorders Testicular Pain	0.00% 0/128 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.	1.4% 1/72 • Number of events 1 • Adverse event data was collected over the duration of the project, from the start of enrollment on 11/21/2012 until study follow-up completion on 11/7/2015. All enrolled participants were assessed over the course of visits through Week 48, and a subset of participants meeting eligibility requirements were followed for an additional 48 weeks. Per protocol, only grade 3 and higher clinical adverse events and lab toxicities are systematically recorded on the Adverse Event Evaluation form and reported here.

Additional Information

Dr. Bob Harris

Westat

Phone: 301-251-1500

Email: bobharris@westat.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications, and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
• Publication restrictions are in place

Restriction type: OTHER