An interventional study of Employment Intervention in HIV Prevention, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to male participants aged 16 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-24.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
The investigators aim to pilot-test a novel social and structural-level HIV intervention for YMSM and YTW of color ages 16-24.
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.
Phase 2 Inclusion Criteria:
Phase 2 Exclusion Criteria:
Phase 3 Inclusion Criteria:
Phase 3 Exclusion Criteria:
An employment intervention (iFOUR) that has been adapted from previous piloting work of focus groups, key informant interviews and a community advisory board.
Behavioral: Employment 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.
Also known as: iFOUR
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
| Milestone | Phase 2 | Phase 3 |
|---|---|---|
| Started | 51 | 0 |
| Completed | 47 | 0 |
| Not completed | 4 | 0 |
| Withdrew: Lost to follow-up | 4 | 0 |
| Milestone | Phase 2 | Phase 3 |
|---|---|---|
| Started | 0 | 41 |
| Completed | 0 | 40 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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).
| units on a scale | Phase 2 | Phase 3 |
|---|---|---|
| Information Systems Success Model Score | 4.4 (4.0 to 4.8) | 4.2 (3.8 to 4.7) |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Participants Completing Two or More Workshop Sessions | 28 | 34 |
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).
| units on a scale | Phase 2 | Phase 3 |
|---|---|---|
| Change From Baseline in Job Seeking Self-Efficacy Scale Score | -0.08 (-0.41 to 0.26) | 0.62 (0.14 to 1.11) |
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).
| units on a scale | Phase 2 | Phase 3 |
|---|---|---|
| Change From Baseline in Protean Career Attitudes Scale Score | -0.09 (-0.25 to 0.06) | -0.03 (-0.27 to 0.21) |
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).
| hours/week | Phase 2 | Phase 3 |
|---|---|---|
| Change From Baseline in Self-Reported Hours Worked Per Week | 11.4 (7.14 to 15.65) | 5.24 (1.54 to 8.94) |
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).
| sexual risk factors | Phase 2 | Phase 3 |
|---|---|---|
| Change From Baseline in Self-Reported Sexual Risk Behaviors | -0.03 (-0.10 to 0.05) | -0.06 (-0.13 to 0.01) |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Positive Test Results at Baseline | 2 | 1 |
| Number of Positive Test Results at Follow-up | 0 | 0 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Positive Test Results at Baseline | 2 | 0 |
| Number of Positive Test Results at Follow-up | 3 | 2 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Positive Test Results at Baseline | 1 | 2 |
| Number of Positive Test Results at Follow-up | 3 | 1 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Positive Test Results at Baseline | 2 | 3 |
| Number of Positive Test Results at Follow-up | 1 | 0 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Positive Test Results at Baseline | 3 | 2 |
| Number of Positive Test Results at Follow-up | 2 | 1 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Positive Test Results at Baseline | 1 | 0 |
| Number of Positive Test Results at Follow-up | 0 | 0 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Reactive HIV Result or Reported New HIV+ Status | 0 | 2 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Yes Responses at Baseline | 14 | 13 |
| Number of Yes Responses at Follow-up | 13 | 12 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Yes Responses at Baseline | 5 | 11 |
| Number of Yes Responses at Follow-up | 5 | 9 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Yes Responses at Baseline | 9 | 14 |
| Number of Yes Responses at Follow-up | 12 | 15 |
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.
| Participants | Phase 2 | Phase 3 |
|---|---|---|
| Number of Yes Responses at Baseline | 13 | 21 |
| Number of Yes Responses at Follow-up | 10 | 15 |
Collected over Adverse event data were collected from the baseline through study completion, approximately 8 months for Phase 2 and 3 months for Phase 3.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 2 | 0/51 (0%) | 0/51 (0%) | 0/51 (0%) |
| Phase 3 | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
The analysis population consists of participants who completed at least one workshop and/or the 8-month (3-month) follow-up visit.
| Age, Continuous(years) | Phase 2 | Phase 3 | Total |
|---|---|---|---|
| Median | 22 (19 to 23) | 22 (20 to 23.5) | 22 (20 to 23) |
| Sex/Gender, Customized(Participants) | Phase 2 | Phase 3 | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 35 | 23 | 58 |
| Transfemale or Transwoman | 6 | 11 | 17 |
| Transmale or Transman | 0 | 0 | 0 |
| Genderqueer or Gender Nonconforming | 3 | 4 | 7 |
| Other Gender Identity | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Phase 2 | Phase 3 | Total |
|---|---|---|---|
| Hispanic or Latino | 11 | 4 | 15 |
| Not Hispanic or Latino | 36 | 36 | 72 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Phase 2 | Phase 3 | Total |
|---|---|---|---|
| Black | 41 | 38 | 79 |
| White | 1 | 0 | 1 |
| Other | 5 | 1 | 6 |
| American Indian or Alaskan Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Phase 2 | Phase 3 | Total |
|---|---|---|---|
| United States | 47 | 40 | 87 |
| Sexual Orientation(Participants) | Phase 2 | Phase 3 | Total |
|---|---|---|---|
| Bisexual | 19 | 12 | 31 |
| Gay | 19 | 18 | 37 |
| Homosexual | 0 | 1 | 1 |
| Queer | 5 | 0 | 5 |
| Same Gender Loving | 0 | 2 | 2 |
| Straight or Heterosexual | 4 | 5 | 9 |
| Other | 0 | 2 | 2 |
| Employment Status(Participants) | Phase 2 | Phase 3 | Total |
|---|---|---|---|
| Not Employed | 41 | 34 | 75 |
| Part-Time | 6 | 6 | 12 |
| Full-Time | 0 | 0 | 0 |
| Job Seeking Self-Efficacy Score(units on a scale) | Phase 2 | Phase 3 | Total |
|---|---|---|---|
| Median | 9.1 (7.9 to 10) | 8.5 (7.6 to 9.9) | 8.8 (7.8 to 10) |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified study data will be made available in the NICHD Data and Specimen Hub (DASH), a centralized resource for researchers to store de-identified data from NICHD supported studies for use in secondary research. NICHD DASH is a free public resource designed for the scientific research community.
Supporting information: Study protocol, Sap
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University of North Carolina, Chapel Hill