Skip to content

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

Work-to-Prevent: Employment as HIV Prevention for Young Men Who Have Sex With Men (YMSM) and Young Transgender Women (YTW)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03313310
Acronym
W2P
Enrollment
92
Registered
2017-10-18
Start date
2018-03-20
Completion date
2019-12-05
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Prevention

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

BEHAVIORALEmployment Intervention

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A single-arm longitudinal pre/post study

Eligibility

Sex/Gender
MALE
Age
16 Years to 24 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Information Systems Success Model ScorePost-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 SessionsPost-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 ScoreBaseline, 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 ScoreBaseline, 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

MeasureTime frameDescription
Change From Baseline in Urine Chlamydia Test ResultBaseline, 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 ResultBaseline, 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 WeekBaseline, 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 ResultBaseline, 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+ StatusFollow-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 ResultBaseline, 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 BehaviorsBaseline, 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 ResultBaseline, 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 ResultBaseline, 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

ArmCount
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
Total87

Withdrawals & dropouts

PeriodReasonFG000FG001
Phase 2Lost to Follow-up40
Phase 3Lost to Follow-up01

Baseline characteristics

CharacteristicTotalPhase 3Phase 2
Age, Continuous22 years22 years22 years
Baseline HIV Test Result
Declined
0 Participants0 Participants0 Participants
Baseline HIV Test Result
HIV+ at Consent
NA Participants11 ParticipantsNA Participants
Baseline HIV Test Result
Non-Reactive
72 Participants27 Participants45 Participants
Baseline HIV Test Result
Reactive
4 Participants2 Participants2 Participants
Employment Status
Full-Time
0 Participants0 Participants0 Participants
Employment Status
Not Employed
75 Participants34 Participants41 Participants
Employment Status
Part-Time
12 Participants6 Participants6 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
15 Participants4 Participants11 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
72 Participants36 Participants36 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Job Seeking Self-Efficacy Score8.8 units on a scale8.5 units on a scale9.1 units on a scale
Number of Self-Reported Sexual Risk Behaviors
0 Criteria
24 Participants8 Participants16 Participants
Number of Self-Reported Sexual Risk Behaviors
1 Criterion
17 Participants8 Participants9 Participants
Number of Self-Reported Sexual Risk Behaviors
2 Criteria
19 Participants8 Participants11 Participants
Number of Self-Reported Sexual Risk Behaviors
3 Criteria
12 Participants7 Participants5 Participants
Number of Self-Reported Sexual Risk Behaviors
4+ Criteria
15 Participants9 Participants6 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Asian
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black
79 Participants38 Participants41 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race/Ethnicity, Customized
Other
6 Participants1 Participants5 Participants
Race/Ethnicity, Customized
White
1 Participants0 Participants1 Participants
Region of Enrollment
United States
87 Participants40 Participants47 Participants
Self-Reported Sexual Risk Behaviors
Anal Intercourse with 3 or More Male Partners
44 Number of events21 Number of events23 Number of events
Self-Reported Sexual Risk Behaviors
Anal Intercourse with Condom Failure
24 Number of events14 Number of events10 Number of events
Self-Reported Sexual Risk Behaviors
CAI with HIV+ Male Partner
18 Number of events10 Number of events8 Number of events
Self-Reported Sexual Risk Behaviors
CAI with Male Partner of Unknown HIV Status
21 Number of events9 Number of events12 Number of events
Self-Reported Sexual Risk Behaviors
Sex with Male Partner with STI
17 Number of events11 Number of events6 Number of events
Self-Reported Sexual Risk Behaviors
Transactional Sex Work Involvement
36 Number of events21 Number of events15 Number of events
Sex/Gender, Customized
Female
5 Participants2 Participants3 Participants
Sex/Gender, Customized
Genderqueer or Gender Nonconforming
7 Participants4 Participants3 Participants
Sex/Gender, Customized
Male
58 Participants23 Participants35 Participants
Sex/Gender, Customized
Other Gender Identity
0 Participants0 Participants0 Participants
Sex/Gender, Customized
Transfemale or Transwoman
17 Participants11 Participants6 Participants
Sex/Gender, Customized
Transmale or Transman
0 Participants0 Participants0 Participants
Sexual Orientation
Bisexual
31 Participants12 Participants19 Participants
Sexual Orientation
Gay
37 Participants18 Participants19 Participants
Sexual Orientation
Homosexual
1 Participants1 Participants0 Participants
Sexual Orientation
Other
2 Participants2 Participants0 Participants
Sexual Orientation
Queer
5 Participants0 Participants5 Participants
Sexual Orientation
Same Gender Loving
2 Participants2 Participants0 Participants
Sexual Orientation
Straight or Heterosexual
9 Participants5 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 510 / 41
other
Total, other adverse events
0 / 510 / 41
serious
Total, serious adverse events
0 / 510 / 41

Outcome results

Primary

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.

ArmMeasureValue (MEAN)
Phase 2Change From Baseline in Job Seeking Self-Efficacy Scale Score-0.08 units on a scale
Phase 3Change From Baseline in Job Seeking Self-Efficacy Scale Score0.62 units on a scale
p-value: 0.98Wilcoxon Signed Rank
p-value: 0.05Wilcoxon Signed Rank
Primary

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.

ArmMeasureValue (MEAN)
Phase 2Change From Baseline in Protean Career Attitudes Scale Score-0.09 units on a scale
Phase 3Change From Baseline in Protean Career Attitudes Scale Score-0.03 units on a scale
p-value: 0.39Wilcoxon Signed Rank
p-value: 0.76Wilcoxon Signed Rank
Primary

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.

ArmMeasureValue (MEDIAN)
Phase 2Information Systems Success Model Score4.4 units on a scale
Phase 3Information Systems Success Model Score4.2 units on a scale
Primary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 2Number of Participants Completing Two or More Workshop Sessions28 Participants
Phase 3Number of Participants Completing Two or More Workshop Sessions34 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Anal Chlamydia Test ResultNumber of Positive Test Results at Baseline2 Participants
Phase 2Change From Baseline in Anal Chlamydia Test ResultNumber of Positive Test Results at Follow-up3 Participants
Phase 3Change From Baseline in Anal Chlamydia Test ResultNumber of Positive Test Results at Baseline0 Participants
Phase 3Change From Baseline in Anal Chlamydia Test ResultNumber of Positive Test Results at Follow-up2 Participants
p-value: 1McNemar
p-value: 0.5McNemar
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Anal Gonorrhea Test ResultNumber of Positive Test Results at Baseline3 Participants
Phase 2Change From Baseline in Anal Gonorrhea Test ResultNumber of Positive Test Results at Follow-up2 Participants
Phase 3Change From Baseline in Anal Gonorrhea Test ResultNumber of Positive Test Results at Follow-up1 Participants
Phase 3Change From Baseline in Anal Gonorrhea Test ResultNumber of Positive Test Results at Baseline2 Participants
p-value: 1McNemar
p-value: 1McNemar
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Oral Chlamydia Test ResultNumber of Positive Test Results at Baseline2 Participants
Phase 2Change From Baseline in Oral Chlamydia Test ResultNumber of Positive Test Results at Follow-up0 Participants
Phase 3Change From Baseline in Oral Chlamydia Test ResultNumber of Positive Test Results at Baseline1 Participants
Phase 3Change From Baseline in Oral Chlamydia Test ResultNumber of Positive Test Results at Follow-up0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Oral Gonorrhea Test ResultNumber of Positive Test Results at Baseline2 Participants
Phase 2Change From Baseline in Oral Gonorrhea Test ResultNumber of Positive Test Results at Follow-up1 Participants
Phase 3Change From Baseline in Oral Gonorrhea Test ResultNumber of Positive Test Results at Baseline3 Participants
Phase 3Change From Baseline in Oral Gonorrhea Test ResultNumber of Positive Test Results at Follow-up0 Participants
p-value: 1McNemar
p-value: 0.25McNemar
Secondary

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.

ArmMeasureValue (MEAN)
Phase 2Change From Baseline in Self-Reported Hours Worked Per Week11.4 hours/week
Phase 3Change From Baseline in Self-Reported Hours Worked Per Week5.24 hours/week
p-value: <0.001Wilcoxon Signed Rank
p-value: 0.02Wilcoxon Signed Rank
Secondary

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.

ArmMeasureValue (MEAN)
Phase 2Change From Baseline in Self-Reported Sexual Risk Behaviors-0.03 sexual risk factors
Phase 3Change From Baseline in Self-Reported Sexual Risk Behaviors-0.06 sexual risk factors
p-value: 0.51Wilcoxon Signed Rank
p-value: 0.17Wilcoxon Signed Rank
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Urine Chlamydia Test ResultNumber of Positive Test Results at Baseline1 Participants
Phase 2Change From Baseline in Urine Chlamydia Test ResultNumber of Positive Test Results at Follow-up3 Participants
Phase 3Change From Baseline in Urine Chlamydia Test ResultNumber of Positive Test Results at Baseline2 Participants
Phase 3Change From Baseline in Urine Chlamydia Test ResultNumber of Positive Test Results at Follow-up1 Participants
p-value: 0.63McNemar
p-value: 1McNemar
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Urine Gonorrhea Test ResultNumber of Positive Test Results at Baseline1 Participants
Phase 2Change From Baseline in Urine Gonorrhea Test ResultNumber of Positive Test Results at Follow-up0 Participants
Phase 3Change From Baseline in Urine Gonorrhea Test ResultNumber of Positive Test Results at Baseline0 Participants
Phase 3Change From Baseline in Urine Gonorrhea Test ResultNumber of Positive Test Results at Follow-up0 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Phase 2Reactive HIV Result or Reported New HIV+ Status0 Participants
Phase 3Reactive HIV Result or Reported New HIV+ Status2 Participants
Post Hoc

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Any Self-reported Condomless Anal IntercourseNumber of Yes Responses at Baseline14 Participants
Phase 2Change From Baseline in Any Self-reported Condomless Anal IntercourseNumber of Yes Responses at Follow-up13 Participants
Phase 3Change From Baseline in Any Self-reported Condomless Anal IntercourseNumber of Yes Responses at Baseline13 Participants
Phase 3Change From Baseline in Any Self-reported Condomless Anal IntercourseNumber of Yes Responses at Follow-up12 Participants
p-value: 1McNemar
p-value: 1McNemar
Post Hoc

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Self-reported Anal Intercourse With Condom FailureNumber of Yes Responses at Baseline9 Participants
Phase 2Change From Baseline in Self-reported Anal Intercourse With Condom FailureNumber of Yes Responses at Follow-up12 Participants
Phase 3Change From Baseline in Self-reported Anal Intercourse With Condom FailureNumber of Yes Responses at Baseline14 Participants
Phase 3Change From Baseline in Self-reported Anal Intercourse With Condom FailureNumber of Yes Responses at Follow-up15 Participants
p-value: 0.55McNemar
p-value: 1McNemar
Post Hoc

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted InfectionNumber of Yes Responses at Baseline5 Participants
Phase 2Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted InfectionNumber of Yes Responses at Follow-up5 Participants
Phase 3Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted InfectionNumber of Yes Responses at Baseline11 Participants
Phase 3Change From Baseline in Self-reported Sex With Male Partner With a Sexually Transmitted InfectionNumber of Yes Responses at Follow-up9 Participants
p-value: 1McNemar
p-value: 0.75McNemar
Post Hoc

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Phase 2Change From Baseline in Self-reported Transactional Sex Work InvolvementNumber of Yes Responses at Baseline13 Participants
Phase 2Change From Baseline in Self-reported Transactional Sex Work InvolvementNumber of Yes Responses at Follow-up10 Participants
Phase 3Change From Baseline in Self-reported Transactional Sex Work InvolvementNumber of Yes Responses at Follow-up15 Participants
Phase 3Change From Baseline in Self-reported Transactional Sex Work InvolvementNumber of Yes Responses at Baseline21 Participants
p-value: 0.45McNemar
p-value: 0.07McNemar

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026