HIV Prevention
Conditions
Keywords
Youth Empowerment, Employment Intervention, Young Men Who Have Sex With Men, Young Transgender Women
Brief summary
The investigators aim to pilot-test a novel social and structural-level HIV intervention for YMSM and YTW of color ages 16-24.
Detailed description
Work2Prevent will advance the science by adapting, tailoring, and pilot-testing a novel social and structural-level HIV intervention for YMSM and YTW of color ages16-24 aimed at increasing economic stability (i.e., employment) through youth empowerment and asset development, and decreasing HIV risk behaviors (i.e., sex work) associated with social and economic marginalization.
Interventions
Participants will complete 4 workshop sessions in groups of 6-12. The workshop curriculum was based on the pre-existing iFOUR program, and tailored based on feedback from a Community Advisory Board (CAB), Focus Groups, and In Depth Interviews.
Sponsors
Study design
Intervention model description
A single-arm longitudinal pre/post study
Eligibility
Inclusion criteria
Phase 2 Inclusion Criteria: 1. Being male or assigned male at birth (YTW) 2. Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman 3. Identifies as African American/Black or Hispanic/Latino 4. 16-24 years old 5. English-speaking (primary) 6. Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk) 7. Is able to attend a 4-session employment program Phase 2
Exclusion criteria
1. Individuals identifying as non-Hispanic White 2. Individuals not assigned male at birth 3. Individuals with a known HIV positive-status at time of consent Phase 3 Inclusion Criteria: 1. Being male or assigned male at birth (YTW) 2. Identifies as a man who has sex with men (YMSM) and/or a gay bisexual man or transgender woman/transwoman 3. Identifies as African American/Black or Hispanic/Latino 4. 16-24 years old 5. English-speaking (primary) 6. Currently unemployed but seeking employment, or employed only part-time (35 hrs or less on avg/wk) 7. Is able to attend a 4-session employment program 8. Did not participate in Phase 2 Phase 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Information Systems Success Model Score | Post-Intervention (up to 2 weeks after completion of intervention) | 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). |
| Number of Participants Completing Two or More Workshop Sessions | Post-Intervention (up to 2 weeks after completion of intervention) | 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. |
| Change From Baseline in Job Seeking Self-Efficacy Scale Score | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) | 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). |
| Change From Baseline in Protean Career Attitudes Scale Score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Urine Chlamydia Test Result | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) | 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. |
| Change From Baseline in Oral Gonorrhea Test Result | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) | 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. |
| Change From Baseline in Self-Reported Hours Worked Per Week | 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). |
| Change From Baseline in Urine Gonorrhea Test Result | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) | 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. |
| Reactive HIV Result or Reported New HIV+ Status | Follow-Up (8 months for Phase 2, 3 months for Phase 3) | 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. |
| Change From Baseline in Anal Gonorrhea Test Result | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) | 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. |
| Change From Baseline in Self-Reported Sexual Risk Behaviors | 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). |
| Change From Baseline in Oral Chlamydia Test Result | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) | 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. |
| Change From Baseline in Anal Chlamydia Test Result | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Phase 2 Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period. | 47 |
| Phase 3 Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period. | 40 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 2 | Lost to Follow-up | 4 | 0 |
| Phase 3 | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Phase 3 | Phase 2 |
|---|---|---|---|
| Age, Continuous | 22 years | 22 years | 22 years |
| Baseline HIV Test Result Declined | 0 Participants | 0 Participants | 0 Participants |
| Baseline HIV Test Result HIV+ at Consent | NA Participants | 11 Participants | NA Participants |
| Baseline HIV Test Result Non-Reactive | 72 Participants | 27 Participants | 45 Participants |
| Baseline HIV Test Result Reactive | 4 Participants | 2 Participants | 2 Participants |
| Employment Status Full-Time | 0 Participants | 0 Participants | 0 Participants |
| Employment Status Not Employed | 75 Participants | 34 Participants | 41 Participants |
| Employment Status Part-Time | 12 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 72 Participants | 36 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Job Seeking Self-Efficacy Score | 8.8 units on a scale | 8.5 units on a scale | 9.1 units on a scale |
| Number of Self-Reported Sexual Risk Behaviors 0 Criteria | 24 Participants | 8 Participants | 16 Participants |
| Number of Self-Reported Sexual Risk Behaviors 1 Criterion | 17 Participants | 8 Participants | 9 Participants |
| Number of Self-Reported Sexual Risk Behaviors 2 Criteria | 19 Participants | 8 Participants | 11 Participants |
| Number of Self-Reported Sexual Risk Behaviors 3 Criteria | 12 Participants | 7 Participants | 5 Participants |
| Number of Self-Reported Sexual Risk Behaviors 4+ Criteria | 15 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 79 Participants | 38 Participants | 41 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 87 Participants | 40 Participants | 47 Participants |
| Self-Reported Sexual Risk Behaviors Anal Intercourse with 3 or More Male Partners | 44 Number of events | 21 Number of events | 23 Number of events |
| Self-Reported Sexual Risk Behaviors Anal Intercourse with Condom Failure | 24 Number of events | 14 Number of events | 10 Number of events |
| Self-Reported Sexual Risk Behaviors CAI with HIV+ Male Partner | 18 Number of events | 10 Number of events | 8 Number of events |
| Self-Reported Sexual Risk Behaviors CAI with Male Partner of Unknown HIV Status | 21 Number of events | 9 Number of events | 12 Number of events |
| Self-Reported Sexual Risk Behaviors Sex with Male Partner with STI | 17 Number of events | 11 Number of events | 6 Number of events |
| Self-Reported Sexual Risk Behaviors Transactional Sex Work Involvement | 36 Number of events | 21 Number of events | 15 Number of events |
| Sex/Gender, Customized Female | 5 Participants | 2 Participants | 3 Participants |
| Sex/Gender, Customized Genderqueer or Gender Nonconforming | 7 Participants | 4 Participants | 3 Participants |
| Sex/Gender, Customized Male | 58 Participants | 23 Participants | 35 Participants |
| Sex/Gender, Customized Other Gender Identity | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transfemale or Transwoman | 17 Participants | 11 Participants | 6 Participants |
| Sex/Gender, Customized Transmale or Transman | 0 Participants | 0 Participants | 0 Participants |
| Sexual Orientation Bisexual | 31 Participants | 12 Participants | 19 Participants |
| Sexual Orientation Gay | 37 Participants | 18 Participants | 19 Participants |
| Sexual Orientation Homosexual | 1 Participants | 1 Participants | 0 Participants |
| Sexual Orientation Other | 2 Participants | 2 Participants | 0 Participants |
| Sexual Orientation Queer | 5 Participants | 0 Participants | 5 Participants |
| Sexual Orientation Same Gender Loving | 2 Participants | 2 Participants | 0 Participants |
| Sexual Orientation Straight or Heterosexual | 9 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 41 |
| other Total, other adverse events | 0 / 51 | 0 / 41 |
| serious Total, serious adverse events | 0 / 51 | 0 / 41 |
Outcome results
Change From Baseline in Job Seeking Self-Efficacy Scale Score
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phase 2 | Change From Baseline in Job Seeking Self-Efficacy Scale Score | -0.08 units on a scale |
| Phase 3 | Change From Baseline in Job Seeking Self-Efficacy Scale Score | 0.62 units on a scale |
Change From Baseline in Protean Career Attitudes Scale Score
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phase 2 | Change From Baseline in Protean Career Attitudes Scale Score | -0.09 units on a scale |
| Phase 3 | Change From Baseline in Protean Career Attitudes Scale Score | -0.03 units on a scale |
Information Systems Success Model Score
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).
Time frame: Post-Intervention (up to 2 weeks after completion of intervention)
Population: The analysis population consists of all participants who completed the post-intervention evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 2 | Information Systems Success Model Score | 4.4 units on a scale |
| Phase 3 | Information Systems Success Model Score | 4.2 units on a scale |
Number of Participants Completing Two or More Workshop Sessions
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2 | Number of Participants Completing Two or More Workshop Sessions | 28 Participants |
| Phase 3 | Number of Participants Completing Two or More Workshop Sessions | 34 Participants |
Change From Baseline in Anal Chlamydia Test Result
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Anal Chlamydia Test Result | Number of Positive Test Results at Baseline | 2 Participants |
| Phase 2 | Change From Baseline in Anal Chlamydia Test Result | Number of Positive Test Results at Follow-up | 3 Participants |
| Phase 3 | Change From Baseline in Anal Chlamydia Test Result | Number of Positive Test Results at Baseline | 0 Participants |
| Phase 3 | Change From Baseline in Anal Chlamydia Test Result | Number of Positive Test Results at Follow-up | 2 Participants |
Change From Baseline in Anal Gonorrhea Test Result
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Anal Gonorrhea Test Result | Number of Positive Test Results at Baseline | 3 Participants |
| Phase 2 | Change From Baseline in Anal Gonorrhea Test Result | Number of Positive Test Results at Follow-up | 2 Participants |
| Phase 3 | Change From Baseline in Anal Gonorrhea Test Result | Number of Positive Test Results at Follow-up | 1 Participants |
| Phase 3 | Change From Baseline in Anal Gonorrhea Test Result | Number of Positive Test Results at Baseline | 2 Participants |
Change From Baseline in Oral Chlamydia Test Result
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Oral Chlamydia Test Result | Number of Positive Test Results at Baseline | 2 Participants |
| Phase 2 | Change From Baseline in Oral Chlamydia Test Result | Number of Positive Test Results at Follow-up | 0 Participants |
| Phase 3 | Change From Baseline in Oral Chlamydia Test Result | Number of Positive Test Results at Baseline | 1 Participants |
| Phase 3 | Change From Baseline in Oral Chlamydia Test Result | Number of Positive Test Results at Follow-up | 0 Participants |
Change From Baseline in Oral Gonorrhea Test Result
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Oral Gonorrhea Test Result | Number of Positive Test Results at Baseline | 2 Participants |
| Phase 2 | Change From Baseline in Oral Gonorrhea Test Result | Number of Positive Test Results at Follow-up | 1 Participants |
| Phase 3 | Change From Baseline in Oral Gonorrhea Test Result | Number of Positive Test Results at Baseline | 3 Participants |
| Phase 3 | Change From Baseline in Oral Gonorrhea Test Result | Number of Positive Test Results at Follow-up | 0 Participants |
Change From Baseline in Self-Reported Hours Worked Per Week
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phase 2 | Change From Baseline in Self-Reported Hours Worked Per Week | 11.4 hours/week |
| Phase 3 | Change From Baseline in Self-Reported Hours Worked Per Week | 5.24 hours/week |
Change From Baseline in Self-Reported Sexual Risk Behaviors
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phase 2 | Change From Baseline in Self-Reported Sexual Risk Behaviors | -0.03 sexual risk factors |
| Phase 3 | Change From Baseline in Self-Reported Sexual Risk Behaviors | -0.06 sexual risk factors |
Change From Baseline in Urine Chlamydia Test Result
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Urine Chlamydia Test Result | Number of Positive Test Results at Baseline | 1 Participants |
| Phase 2 | Change From Baseline in Urine Chlamydia Test Result | Number of Positive Test Results at Follow-up | 3 Participants |
| Phase 3 | Change From Baseline in Urine Chlamydia Test Result | Number of Positive Test Results at Baseline | 2 Participants |
| Phase 3 | Change From Baseline in Urine Chlamydia Test Result | Number of Positive Test Results at Follow-up | 1 Participants |
Change From Baseline in Urine Gonorrhea Test Result
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Urine Gonorrhea Test Result | Number of Positive Test Results at Baseline | 1 Participants |
| Phase 2 | Change From Baseline in Urine Gonorrhea Test Result | Number of Positive Test Results at Follow-up | 0 Participants |
| Phase 3 | Change From Baseline in Urine Gonorrhea Test Result | Number of Positive Test Results at Baseline | 0 Participants |
| Phase 3 | Change From Baseline in Urine Gonorrhea Test Result | Number of Positive Test Results at Follow-up | 0 Participants |
Reactive HIV Result or Reported New HIV+ Status
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 2 | Reactive HIV Result or Reported New HIV+ Status | 0 Participants |
| Phase 3 | Reactive HIV Result or Reported New HIV+ Status | 2 Participants |
Change From Baseline in Any Self-reported Condomless Anal Intercourse
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Any Self-reported Condomless Anal Intercourse | Number of Yes Responses at Baseline | 14 Participants |
| Phase 2 | Change From Baseline in Any Self-reported Condomless Anal Intercourse | Number of Yes Responses at Follow-up | 13 Participants |
| Phase 3 | Change From Baseline in Any Self-reported Condomless Anal Intercourse | Number of Yes Responses at Baseline | 13 Participants |
| Phase 3 | Change From Baseline in Any Self-reported Condomless Anal Intercourse | Number of Yes Responses at Follow-up | 12 Participants |
Change From Baseline in Self-reported Anal Intercourse With Condom Failure
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Self-reported Anal Intercourse With Condom Failure | Number of Yes Responses at Baseline | 9 Participants |
| Phase 2 | Change From Baseline in Self-reported Anal Intercourse With Condom Failure | Number of Yes Responses at Follow-up | 12 Participants |
| Phase 3 | Change From Baseline in Self-reported Anal Intercourse With Condom Failure | Number of Yes Responses at Baseline | 14 Participants |
| Phase 3 | Change From Baseline in Self-reported Anal Intercourse With Condom Failure | Number of Yes Responses at Follow-up | 15 Participants |
Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted Infection
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted Infection | Number of Yes Responses at Baseline | 5 Participants |
| Phase 2 | Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted Infection | Number of Yes Responses at Follow-up | 5 Participants |
| Phase 3 | Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted Infection | Number of Yes Responses at Baseline | 11 Participants |
| Phase 3 | Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted Infection | Number of Yes Responses at Follow-up | 9 Participants |
Change From Baseline in Self-reported Transactional Sex Work Involvement
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 2 | Change From Baseline in Self-reported Transactional Sex Work Involvement | Number of Yes Responses at Baseline | 13 Participants |
| Phase 2 | Change From Baseline in Self-reported Transactional Sex Work Involvement | Number of Yes Responses at Follow-up | 10 Participants |
| Phase 3 | Change From Baseline in Self-reported Transactional Sex Work Involvement | Number of Yes Responses at Follow-up | 15 Participants |
| Phase 3 | Change From Baseline in Self-reported Transactional Sex Work Involvement | Number of Yes Responses at Baseline | 21 Participants |