Trial Outcomes & Findings for Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM) (NCT NCT03414372)
NCT ID: NCT03414372
Last Updated: 2023-03-06
Results Overview
Chart review or drawn for study. Viral load suppression will be defined as HIV RNA \< lower limit of detection as per the laboratory at each clinical site.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
156 participants
Primary outcome timeframe
Month 6
Results posted on
2023-03-06
Participant Flow
Participant milestones
| Measure |
Tough Talks Online
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
52
|
|
Overall Study
COMPLETED
|
43
|
42
|
44
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tough Talks: A Disclosure Intervention for HIV+ Young Men Who Have Sex With Men (YMSM)
Baseline characteristics by cohort
| Measure |
Tough Talks Online
n=53 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=51 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=52 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
23.19 years
STANDARD_DEVIATION 3.50 • n=5 Participants
|
23.92 years
STANDARD_DEVIATION 3.35 • n=7 Participants
|
24.23 years
STANDARD_DEVIATION 3.46 • n=5 Participants
|
23.78 years
STANDARD_DEVIATION 3.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Data are reported for those participants who had a Month 6 viral load assessment.
Chart review or drawn for study. Viral load suppression will be defined as HIV RNA \< lower limit of detection as per the laboratory at each clinical site.
Outcome measures
| Measure |
Tough Talks Online
n=39 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=39 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=41 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
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|---|---|---|---|
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Number of Participants With Suppressed Viral Load
|
29 Participants
|
31 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Data are reported for those participants who completed Month 6 survey and for which non-missing data are present.
Number of participants at month 6 with \>/= 1 act of condomless anal intercourse with a partner who is not known to be HIV-positive within the last 3 months.
Outcome measures
| Measure |
Tough Talks Online
n=29 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=22 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=25 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
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|---|---|---|---|
|
Number of Participants Who Had Condomless Anal Intercourse With a Potentially Susceptible Partner
|
11 Participants
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Month 6Population: Participants were free to choose not to answer this question. Data reported for all non-missing values.
Measured using the Intention to Disclose scale which asks a single item: "I plan on telling my HIV status to all of my new partners before we have sex" and is rated using a 5-point Likert-type response scale. Scores range from 1 to 5 where '1' is "Strongly agree" and '5' is "Strongly disagree. "Lower scores indicate increased intention to disclose.
Outcome measures
| Measure |
Tough Talks Online
n=40 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=40 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=40 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
|---|---|---|---|
|
Mean Intention to Disclose Score
|
1.45 score on a scale
Standard Deviation 0.50
|
1.33 score on a scale
Standard Deviation 0.47
|
1.15 score on a scale
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: Month 6Population: Participants could choose not to respond to any of the six questions. Responses for participants who chose not to respond to any of the six questions were not counted.
Measure of perceived ability to disclose HIV-seropositive status to casual sex partners in six scenarios. Scores were summed with higher scores indicating increased perceived ability to disclose. Six Questions were asked using a 5 point Likert Scale: 1=Absolutely sure I cannot; 2=Somewhat sure I cannot; 3=Not sure; 4=Somewhat sure I can; and 5=Absolutely sure I can. Scores range from 6-30.
Outcome measures
| Measure |
Tough Talks Online
n=38 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=37 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=36 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
|---|---|---|---|
|
Mean Disclosure Self-Efficacy Score
|
22.89 score on a scale
Standard Deviation 7.69
|
23.03 score on a scale
Standard Deviation 6.54
|
25.64 score on a scale
Standard Deviation 7.24
|
SECONDARY outcome
Timeframe: Month 6Population: Participants could choose not to respond to any of the eight questions. Responses for participants who chose not to respond to any of the eight questions were not counted.
Measure of a participant's perceived negative consequences of disclosing of their HIV status to a partner (e.g., "Relationship would get bad", "Person would not want to be around me"), with higher scores indicating higher perceived negative consequences of disclosure. Eight Questions rated using a 4-point Likert Scale 1=Strongly disagree 2=Disagree 3=Agree 4=Strongly Agree. Scores range from 8 to 32.
Outcome measures
| Measure |
Tough Talks Online
n=43 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=42 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=40 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
|---|---|---|---|
|
Mean Consequences of Disclosure (Cost) Score
|
23.40 score on a scale
Standard Deviation 8.19
|
24.07 score on a scale
Standard Deviation 8.84
|
19.20 score on a scale
Standard Deviation 8.95
|
SECONDARY outcome
Timeframe: Month 6Population: Participants could choose not to respond to any of the ten questions. Responses for participants who chose not to respond to any of the ten questions were not counted.
Measure of a participant's perceived positive consequences of disclosing of their HIV status to a partner (e.g., "Keep them safe from HIV", "Improve the relationship"), with higher scores indicating higher perceived positive consequences of disclosure. Ten Questions rated using a 4-point Likert Scale 1=Strongly disagree; 2=Disagree; 3=Agree; and 4=Strongly Agree. Scores range from 10-40.
Outcome measures
| Measure |
Tough Talks Online
n=36 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=34 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=32 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
|---|---|---|---|
|
Mean Consequences of Disclosure (Rewards) Score
|
32.22 score on a scale
Standard Deviation 6.02
|
34.18 score on a scale
Standard Deviation 6.15
|
34.31 score on a scale
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: Month 6Population: Participants were free to choose not to answer this question. Data reported for all non-missing values.
Measured using a single question: "How many of your immediate family members are not aware of your HIV status but to whom you want to disclose?" and rated using a 5-point Likert Scale: 1=None; 2=Some, but less than half; 3=About half; 4=More than half; and 5=All. Scores range from 1 to 5 with lower scores indicating increased disclosure behaviors.
Outcome measures
| Measure |
Tough Talks Online
n=42 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=37 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=34 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
|---|---|---|---|
|
Mean Disclosure Self-Regulation (Family) Score
|
2.57 score on a scale
Standard Deviation 1.53
|
2.51 score on a scale
Standard Deviation 1.48
|
2.59 score on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Month 6Population: Participants were free to choose not to answer this question. Data reported for all non-missing values.
Measured using a single question: "How many of your peers are not aware of your HIV status but to whom you want to disclose?" and rated using a 5-point Likert Scale: 1=None; 2=Some, but less than half; 3=About half; 4=More than half; and 5=All. Scores range from 1 to 5 with lower scores indicating increased disclosure behaviors.
Outcome measures
| Measure |
Tough Talks Online
n=41 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=39 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=36 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
|---|---|---|---|
|
Mean Disclosure Self-Regulation (Peers) Score
|
2.49 score on a scale
Standard Deviation 1.49
|
2.33 score on a scale
Standard Deviation 1.18
|
2.67 score on a scale
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: Month 6Population: Participants were free to choose not to answer this question. Data reported for all non-missing values.
Measured using a single question: "How many of your current and past sexual partners are not aware of your HIV status but to whom you want to disclose?" and rated using a 5-point Likert Scale: 1=None; 2=Some, but less than half; 3=About half; 4=More than half; and 5=All. Scores range from 1 to 5 with lower scores indicating increased disclosure behaviors.
Outcome measures
| Measure |
Tough Talks Online
n=39 Participants
Participants will use Tough Talks Online
Tough Talks Online: Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
|
Tough Talks Clinic
n=37 Participants
Participants will use receive Tough Talks in a clinic
Tough Talks Clinic: Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
|
Standard of Care
n=34 Participants
Participants will receive the standard of care (SOC).
Standard of Care: Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
|
|---|---|---|---|
|
Mean Disclosure Self-Regulation (Sexual Partners) Score
|
2.08 score on a scale
Standard Deviation 1.40
|
1.68 score on a scale
Standard Deviation 1.03
|
1.71 score on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Month 6Population: Although the protocol was not amended to remove this assessment, this scale was not used as study staff anticipated the questions included may be offensive to young participants.
Measure of how a participant anticipates their behavior impacts their feelings or assessment of HIV protective behaviors. Higher scores indicate a more favorable/stronger evaluation/endorsement of HIV protective behaviors. Participant's self-evaluation based on six questions using a 5-point Likert scale (1, strongly disagree to 5, strongly agree) ranging from 5 to 30.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6Population: Although the protocol was not amended to remove this assessment, this scale was not used as study staff anticipated the questions included may be offensive to young participants.
Measure of how a participant anticipates their behavior impacts their feelings or assessment of sexual pleasure or sensuality. Lower scores indicate a more favorable/stronger evaluation/endorsement of HIV protective behaviors. Participant's self-evaluation based on three questions using a 5-point Likert scale (1, strongly disagree to 5, strongly agree) ranging from 3 to 15.
Outcome measures
Outcome data not reported
Adverse Events
Tough Talks Online
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tough Talks Clinic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bryce Stamp, MPH
University of North Carolina at Chapel Hill
Phone: 919-966-7430
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place