Trial Outcomes & Findings for ATN 151 Work-to-Prevent: Employment as HIV Prevention (NCT NCT03313310)
NCT ID: 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).
COMPLETED
NA
92 participants
Post-Intervention (up to 2 weeks after completion of intervention)
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
| 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
| 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
| 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=99 Participants
|
22 years
n=107 Participants
|
22 years
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
35 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Transfemale or Transwoman
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Transmale or Transman
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Genderqueer or Gender Nonconforming
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Other Gender Identity
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
41 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
47 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Sexual Orientation
Bisexual
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sexual Orientation
Gay
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sexual Orientation
Homosexual
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sexual Orientation
Queer
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sexual Orientation
Same Gender Loving
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sexual Orientation
Straight or Heterosexual
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sexual Orientation
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Employment Status
Not Employed
|
41 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Employment Status
Part-Time
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Employment Status
Full-Time
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Job Seeking Self-Efficacy Score
|
9.1 units on a scale
n=99 Participants
|
8.5 units on a scale
n=107 Participants
|
8.8 units on a scale
n=206 Participants
|
|
Baseline HIV Test Result
Reactive
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Baseline HIV Test Result
Non-Reactive
|
45 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Baseline HIV Test Result
Declined
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Baseline HIV Test Result
HIV+ at Consent
|
NA Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
|
Self-Reported Sexual Risk Behaviors
CAI with Male Partner of Unknown HIV Status
|
12 Number of events
n=99 Participants
|
9 Number of events
n=107 Participants
|
21 Number of events
n=206 Participants
|
|
Self-Reported Sexual Risk Behaviors
Anal Intercourse with 3 or More Male Partners
|
23 Number of events
n=99 Participants
|
21 Number of events
n=107 Participants
|
44 Number of events
n=206 Participants
|
|
Self-Reported Sexual Risk Behaviors
Sex with Male Partner with STI
|
6 Number of events
n=99 Participants
|
11 Number of events
n=107 Participants
|
17 Number of events
n=206 Participants
|
|
Self-Reported Sexual Risk Behaviors
CAI with HIV+ Male Partner
|
8 Number of events
n=99 Participants
|
10 Number of events
n=107 Participants
|
18 Number of events
n=206 Participants
|
|
Self-Reported Sexual Risk Behaviors
Anal Intercourse with Condom Failure
|
10 Number of events
n=99 Participants
|
14 Number of events
n=107 Participants
|
24 Number of events
n=206 Participants
|
|
Self-Reported Sexual Risk Behaviors
Transactional Sex Work Involvement
|
15 Number of events
n=99 Participants
|
21 Number of events
n=107 Participants
|
36 Number of events
n=206 Participants
|
|
Number of Self-Reported Sexual Risk Behaviors
0 Criteria
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Number of Self-Reported Sexual Risk Behaviors
1 Criterion
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Number of Self-Reported Sexual Risk Behaviors
2 Criteria
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Number of Self-Reported Sexual Risk Behaviors
3 Criteria
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Number of Self-Reported Sexual Risk Behaviors
4+ Criteria
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 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.
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).
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
| 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
| 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)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.
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
| 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)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.
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
| 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)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.
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
| 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
| 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
| 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
| 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
| 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
| 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)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.
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
| 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
| 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)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.
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
| 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)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.
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
| 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)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.
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
| 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)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.
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
| 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
Phase 3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place