Trial Outcomes & Findings for ATN 151 Work-to-Prevent: Employment as HIV Prevention (NCT NCT03313310)

Last Updated: 2020-11-24

Results Overview

The Information Systems Success Model (ISSM) will be used to assess for intervention acceptability and satisfaction. The 21-item scale measures four sub-domains: information quality, handbook quality, perceived usefulness, and overall satisfaction. Every item is scored on a 1-5 scale, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". Responses are averaged within each sub-domain to produce four sub-domain scores. The four sub-domain scores are then averaged to produce an overall ISSM score (1-5; higher scores indicate higher acceptability/satisfaction).

Recruitment status

COMPLETED

Study phase

Target enrollment

92 participants

Primary outcome timeframe

Post-Intervention (up to 2 weeks after completion of intervention)

Results posted on

2020-11-24

Participant Flow

Participants will be recruited in clinics serving young men who have sex with men (YMSM) and young transwomen (YTW) of color, and local gathering places for YMSM and YTW. Participants will be asked to refer potentially eligible friends or acquaintances. Passive recruitment will include posting study flyers and describing the study on social media.

Participant milestones

Participant milestones
Measure	Phase 2 Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Phase 2 STARTED	51	0
Phase 2 COMPLETED	47	0
Phase 2 NOT COMPLETED	4	0
Phase 3 STARTED	0	41
Phase 3 COMPLETED	0	40
Phase 3 NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 2 Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Phase 2 Lost to Follow-up	4	0
Phase 3 Lost to Follow-up	0	1

Baseline Characteristics

ATN 151 Work-to-Prevent: Employment as HIV Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 2 n=47 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=40 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.	Total n=87 Participants Total of all reporting groups
Age, Continuous	22 years n=5 Participants	22 years n=7 Participants	22 years n=5 Participants
Sex/Gender, Customized Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex/Gender, Customized Male	35 Participants n=5 Participants	23 Participants n=7 Participants	58 Participants n=5 Participants
Sex/Gender, Customized Transfemale or Transwoman	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex/Gender, Customized Transmale or Transman	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Genderqueer or Gender Nonconforming	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex/Gender, Customized Other Gender Identity	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	36 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants
Race/Ethnicity, Customized White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	47 Participants n=5 Participants	40 Participants n=7 Participants	87 Participants n=5 Participants
Sexual Orientation Bisexual	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Sexual Orientation Gay	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Sexual Orientation Homosexual	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sexual Orientation Queer	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Sexual Orientation Same Gender Loving	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sexual Orientation Straight or Heterosexual	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sexual Orientation Other	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Employment Status Not Employed	41 Participants n=5 Participants	34 Participants n=7 Participants	75 Participants n=5 Participants
Employment Status Part-Time	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Employment Status Full-Time	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Job Seeking Self-Efficacy Score	9.1 units on a scale n=5 Participants	8.5 units on a scale n=7 Participants	8.8 units on a scale n=5 Participants
Baseline HIV Test Result Reactive	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Baseline HIV Test Result Non-Reactive	45 Participants n=5 Participants	27 Participants n=7 Participants	72 Participants n=5 Participants
Baseline HIV Test Result Declined	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline HIV Test Result HIV+ at Consent	NA Participants n=5 Participants	11 Participants n=7 Participants	NA Participants n=5 Participants
Self-Reported Sexual Risk Behaviors CAI with Male Partner of Unknown HIV Status	12 Number of events n=5 Participants	9 Number of events n=7 Participants	21 Number of events n=5 Participants
Self-Reported Sexual Risk Behaviors Anal Intercourse with 3 or More Male Partners	23 Number of events n=5 Participants	21 Number of events n=7 Participants	44 Number of events n=5 Participants
Self-Reported Sexual Risk Behaviors Sex with Male Partner with STI	6 Number of events n=5 Participants	11 Number of events n=7 Participants	17 Number of events n=5 Participants
Self-Reported Sexual Risk Behaviors CAI with HIV+ Male Partner	8 Number of events n=5 Participants	10 Number of events n=7 Participants	18 Number of events n=5 Participants
Self-Reported Sexual Risk Behaviors Anal Intercourse with Condom Failure	10 Number of events n=5 Participants	14 Number of events n=7 Participants	24 Number of events n=5 Participants
Self-Reported Sexual Risk Behaviors Transactional Sex Work Involvement	15 Number of events n=5 Participants	21 Number of events n=7 Participants	36 Number of events n=5 Participants
Number of Self-Reported Sexual Risk Behaviors 0 Criteria	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Number of Self-Reported Sexual Risk Behaviors 1 Criterion	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Number of Self-Reported Sexual Risk Behaviors 2 Criteria	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Number of Self-Reported Sexual Risk Behaviors 3 Criteria	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Number of Self-Reported Sexual Risk Behaviors 4+ Criteria	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post-Intervention (up to 2 weeks after completion of intervention)

Population: The analysis population consists of all participants who completed the post-intervention evaluation.

Outcome measures

Outcome measures
Measure	Phase 2 n=33 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=37 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Information Systems Success Model Score	4.4 units on a scale Interval 4.0 to 4.8	4.2 units on a scale Interval 3.8 to 4.7

PRIMARY outcome

Timeframe: Post-Intervention (up to 2 weeks after completion of intervention)

Population: The analysis population consists of participants who completed at least one workshop and/or the 8-month follow-up visit.

Workshop completion will be used to assess for intervention feasibility, as the workshop sessions are the intervention. Workshop completion will be defined as having attended at least two of the four workshop sessions and will be measured by tracking participant attendance.

Outcome measures

Outcome measures
Measure	Phase 2 n=47 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=40 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Number of Participants Completing Two or More Workshop Sessions	28 Participants	34 Participants

PRIMARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Population: The phase 2 (phase 3) analysis population consists of participants who completed at least one workshop and/or the 8-month (3-month) follow-up visit. Participants with missing data at baseline and/or follow-up were excluded from the analysis.

Job seeking self-efficacy is defined as one's perceived ability and confidence to perform job search and application activities. The 12-item Job Seeking Self-Efficacy (JSS) scale uses response values on a 1-10 score, with 1 being "Not at All Confident" and 10 being "Very Confident". Responses are averaged to yield a total score, with higher scores indicating higher self-efficacy. Change in JSS will be calculated by subtracting the JSS score at baseline (T1) from the JSS score at the 8-month follow-up (T3) (-9 to +9; negative change indicates decreased self-efficacy, while positive change indicates increased self-efficacy).

Outcome measures

Outcome measures
Measure	Phase 2 n=46 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=40 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Job Seeking Self-Efficacy Scale Score	-0.08 units on a scale Interval -0.41 to 0.26	0.62 units on a scale Interval 0.14 to 1.11

PRIMARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Protean career attitudes (PCAs) are defined as having self-direction in the pursuit of success in one's work. PCAs have previously been found to be associated with positive career satisfaction and self-perceived success. The validated 7-item scale measures two sub-domains: self-directed attitudes and values-driven attitudes. Every item is scored on a 1-5 scale, with 1 being "Strongly Disagree" and 5 being "Strongly Agree". Responses are averaged within each sub-domain to produce two sub-domain scores, which are then averaged as well to produce an overall PCA score. Change in PCA score will be calculated by subtracting the score at baseline (T1) from the score at the 8-month follow-up (T3) (-4 to +4; negative change indicates decreased PCAs, while positive change indicates increased PCAs).

Outcome measures

Outcome measures
Measure	Phase 2 n=44 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=38 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Protean Career Attitudes Scale Score	-0.09 units on a scale Interval -0.25 to 0.06	-0.03 units on a scale Interval -0.27 to 0.21

SECONDARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Employment status will be assessed using self-reported average number of hours worked each week. Change in hours worked per week will be calculated by subtracting the baseline (T1) value from the follow-up (T3) value (negative change indicates fewer hours worked per week, while positive change indicates more hours work per week).

Outcome measures

Outcome measures
Measure	Phase 2 n=43 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=37 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Self-Reported Hours Worked Per Week	11.4 hours/week Interval 7.14 to 15.65	5.24 hours/week Interval 1.54 to 8.94

SECONDARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Sexual risk behaviors will be measured using 6 yes/no items assessing for engagement in the following behaviors during the past 6 months (this refers to the 6 months prior to the baseline visit for the first assessment and 6 months prior to the 8 month visit for the second assessment) for Phase 2, and the last 3 months for Phase 3: 1. condomless anal intercourse (CAI) with male partner of unknown HIV status 2. anal intercourse with 3 or more males 3. sex with male partner with a Sexually Transmitted Infection (STI) 4. CAI with HIV+ male partner 5. anal intercourse with condom failure 6. transactional sex work involvement Responses will be averaged at each assessment. Change in sexual risk behaviors will be calculated by subtracting the average at baseline from the average at the 8-month follow-up (range: -1 to +1; negative change indicates fewer sexual risk behaviors, while positive change indicates more sexual risk behaviors).

Outcome measures

Outcome measures
Measure	Phase 2 n=44 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=38 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Self-Reported Sexual Risk Behaviors	-0.03 sexual risk factors Interval -0.1 to 0.05	-0.06 sexual risk factors Interval -0.13 to 0.01

SECONDARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Population: The phase 2 (phase 3) analysis population consists of participants who completed at least one workshop and/or the 8-month (3-month) follow-up visit. 2 phase 2 participants who declined testing were excluded. 10 phase 2 and 8 phase 3 participants whose test results were missing, not collected, or unknown at baseline and/or follow-up were excluded.

Chlamydia infection will be assessed at baseline and follow-up using an oral sample. The test yields a positive (1) or negative (0) result. The number of positive test results at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=35 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=32 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Oral Chlamydia Test Result Number of Positive Test Results at Baseline	2 Participants	1 Participants
Change From Baseline in Oral Chlamydia Test Result Number of Positive Test Results at Follow-up	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Population: The phase 2 (phase 3) analysis population consists of those who completed at least one workshop and/or the 8-month (3-month) follow-up. 1 phase 2 and 1 phase 3 participant who declined testing were excluded. 18 phase 2 and 8 phase 3 participants whose test results were missing, not collected, or unknown at baseline and/or follow-up were excluded.

Chlamydia infection will be assessed at baseline and follow up using an anal sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=28 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=31 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Anal Chlamydia Test Result Number of Positive Test Results at Baseline	2 Participants	0 Participants
Change From Baseline in Anal Chlamydia Test Result Number of Positive Test Results at Follow-up	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Population: The phase 2 (phase 3) analysis population consists of participants who completed at least one workshop and/or the 8-month (3-month) follow-up visit. 1 phase 2 participant who declined testing was excluded. 12 phase 2 and 5 phase 3 participants whose test results were missing, not collected, or unknown at baseline and/or follow-up were excluded.

Chlamydia infection will be assessed at baseline and follow up using a urine sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=34 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=35 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Urine Chlamydia Test Result Number of Positive Test Results at Baseline	1 Participants	2 Participants
Change From Baseline in Urine Chlamydia Test Result Number of Positive Test Results at Follow-up	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Population: The phase 2 (phase 3) analysis population consists of participants who completed at least one workshop and/or the 8-month (3-month) follow-up. 2 phase 2 participants who declined testing were excluded. 10 phase 2 and 9 phase 3 participants whose test results were missing, not collected, or unknown at baseline and/or follow-up were excluded.

Gonorrhea infection will be assessed at baseline and follow-up using an oral sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=35 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=31 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Oral Gonorrhea Test Result Number of Positive Test Results at Baseline	2 Participants	3 Participants
Change From Baseline in Oral Gonorrhea Test Result Number of Positive Test Results at Follow-up	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Population: The phase 2 (phase 3) analysis population consists of those who completed at least one workshop and/or the 8-month (3-month) follow-up. 1 phase 2 and 2 phase 3 participants who declined testing were excluded. 17 phase 2 and 7 phase 3 participants whose test results were missing, not collected, or unknown at baseline and/or follow-up were excluded.

Gonorrhea infection will be assessed at baseline and follow-up using an anal sample. The test yields a positive (1) or negative (0) result. Number of positive test results at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=29 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=31 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Anal Gonorrhea Test Result Number of Positive Test Results at Baseline	3 Participants	2 Participants
Change From Baseline in Anal Gonorrhea Test Result Number of Positive Test Results at Follow-up	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Outcome measures

Outcome measures
Measure	Phase 2 n=34 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=35 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Urine Gonorrhea Test Result Number of Positive Test Results at Baseline	1 Participants	0 Participants
Change From Baseline in Urine Gonorrhea Test Result Number of Positive Test Results at Follow-up	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Population: The phase 2 (phase 3) analysis population consists of those who completed at least one workshop and/or the 8-month (3-month) follow-up. Participants with missing data at either time point were excluded from the analysis. Participants who reported HIV+ status were not tested. Two phase 3 participants reported new HIV+ status at follow-up.

HIV infection will be assessed at follow-up using reactive HIV testing. Test results yield: Reactive or Non-reactive. Participants who reported HIV+ status will not be tested. A reactive HIV result will be defined as those with a "Reactive" result. Reported new HIV+ status is defined as those who report positive HIV status at follow-up and who were tested for HIV, with a non-reactive result, at baseline.

Outcome measures

Outcome measures
Measure	Phase 2 n=37 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=24 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Reactive HIV Result or Reported New HIV+ Status	0 Participants	2 Participants

POST_HOC outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Self-reported condomless anal intercourse will be measured using 2 yes/no items assessing for engagement in the following behaviors during the past 6 months (this refers to the 6 months prior to the baseline visit for the first assessment and 6 months prior to the 8 month visit for the second assessment) for Phase 2, and the last 3 months for Phase 3: 1. CAI with male partner of unknown HIV status 2. CAI with HIV+ male partner Number of yes responses at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=44 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=38 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Any Self-reported Condomless Anal Intercourse Number of Yes Responses at Baseline	14 Participants	13 Participants
Change From Baseline in Any Self-reported Condomless Anal Intercourse Number of Yes Responses at Follow-up	13 Participants	12 Participants

POST_HOC outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Self-reported sex with a male partner with a sexually transmitted infection during the past 6 months (this refers to the 6 months prior to the baseline visit for the first assessment and 6 months prior to the 8 month visit for the second assessment) for Phase 2, and the last 3 months for Phase 3, will be measured using a yes/no item. Number of yes responses at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=44 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=37 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted Infection Number of Yes Responses at Baseline	5 Participants	11 Participants
Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted Infection Number of Yes Responses at Follow-up	5 Participants	9 Participants

POST_HOC outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Self-reported anal intercourse where the condom broke or slipped during the past 6 months (this refers to the 6 months prior to the baseline visit for the first assessment and 6 months prior to the 8 month visit for the second assessment) for Phase 2, and the last 3 months for Phase 3, will be measured using a yes/no item. Number of yes responses at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=44 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=38 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Self-reported Anal Intercourse With Condom Failure Number of Yes Responses at Baseline	9 Participants	14 Participants
Change From Baseline in Self-reported Anal Intercourse With Condom Failure Number of Yes Responses at Follow-up	12 Participants	15 Participants

POST_HOC outcome

Timeframe: Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3)

Self-reported transactional sex work involvement during the past 6 months (this refers to the 6 months prior to the baseline visit for the first assessment and 6 months prior to the 8 month visit for the second assessment) for Phase 2, and the last 3 months for Phase 3, will be measured using a yes/no item. Number of yes responses at baseline and follow-up will be calculated.

Outcome measures

Outcome measures
Measure	Phase 2 n=44 Participants Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period.	Phase 3 n=38 Participants Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period.
Change From Baseline in Self-reported Transactional Sex Work Involvement Number of Yes Responses at Baseline	13 Participants	21 Participants
Change From Baseline in Self-reported Transactional Sex Work Involvement Number of Yes Responses at Follow-up	10 Participants	15 Participants

Adverse Events

Phase 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Betty Rupp

UNC Chapel Hill, ATN Coordinating Center

Phone: 919-962-6603

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place