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| ID | Type | Description | Link |
|---|---|---|---|
| 5U24HD089880-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Employment Intervention | Experimental | An employment intervention (iFOUR) that has been adapted from previous piloting work of focus groups, key informant interviews and a community advisory board. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Employment Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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). | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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Phase 2 Inclusion Criteria:
Phase 2 Exclusion Criteria:
Phase 3 Inclusion Criteria:
Phase 3 Exclusion Criteria:
Self-identifies as: (1) man who has sex with men (MSM) and/or gay or bisexual man or (2) transgender woman and/or transsexual male-to-female/transwoman.
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Hill, PhD | University of Chicago | Principal Investigator |
| Lisa Strader, MPH | University of North Carolina, Chapel Hill | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Barlow J., Wright C., Cullen L. A job-seeking self-efficacy scale for people with physical disabilities:preliminary development and psychometric testing. British Journal of Guidance and Counseling. 2002;30(1):37-53. | ||
| Background | Porter C., Woo S.E., Tak, J. Developing and Validating Short Form Protean and Boundaryless Career Attitudes Scales. Journal of Career Assessment. 2016;24(1):162-181. | ||
| 23553347 | Background | Horvath KJ, Oakes JM, Rosser BR, Danilenko G, Vezina H, Amico KR, Williams ML, Simoni J. Feasibility, acceptability and preliminary efficacy of an online peer-to-peer social support ART adherence intervention. AIDS Behav. 2013 Jul;17(6):2031-44. doi: 10.1007/s10461-013-0469-1. | |
| Background | Volmer J., Spurk D. Protean and boundaryless career attitudes: relationships with subjective and objective career success. 2011;43(3):207-218. |
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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.
Data will be made available after data analyses have been completed, data has been de-identified, and all DASH submission requirements have been met and approved. Data will be available according to NICHD DASH timelines.
Please see DASH guidelines for access criteria.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 2 | Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period. |
| FG001 | Phase 3 | Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 2 |
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| ||||||||||||||||||
| Phase 3 |
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The analysis population consists of participants who completed at least one workshop and/or the 8-month (3-month) follow-up visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2 | Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period. |
| BG001 | Phase 3 | Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | The analysis population consists of all participants who completed the post-intervention evaluation. | Posted | Median | Inter-Quartile Range | units on a scale | Post-Intervention (up to 2 weeks after completion of intervention) |
|
Adverse event data were collected from the baseline through study completion, approximately 8 months for Phase 2 and 3 months for Phase 3.
In addition to adverse events, untoward event data were collected, and are defined as unexpected occurrences involving study participants, study staff, or the community where the study is taking place, that may reasonably be judged as related to study procedures and that lead to harm, distress, or increased risk of harm or distress, but that do not otherwise meet the definition of an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 2 | Phase 2 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-week period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Betty Rupp | UNC Chapel Hill, ATN Coordinating Center | 919-962-6603 | brupp@email.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2019 | May 15, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2019 | Oct 6, 2020 | SAP_001.pdf |
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A single-arm longitudinal pre/post study
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|
|
| 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:
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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
| 35551157 | Derived | Hill BJ, Motley DN, Rosentel K, VandeVusse A, Fuller C, Bowers SME, Williams M, Kipke M, Kuhns L, Pashka N, Reisner S, DeMonte JB, Goolsby RW, Rupp BM, Slye N, Strader LC, Schneider JA, Razzano L, Garofalo R. Employment as HIV Prevention: An Employment Support Intervention for Adolescent Men Who Have Sex With Men and Adolescent Transgender Women of Color. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):31-38. doi: 10.1097/QAI.0000000000003020. Epub 2022 May 12. |
| 32915162 | Derived | Hill BJ, Motley DN, Rosentel K, VandeVusse A, Garofalo R, Kuhns LM, Kipke MD, Reisner S, Rupp B, West Goolsby R, McCumber M, Renshaw L, Schneider JA. Work2Prevent, an Employment Intervention Program as HIV Prevention for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 3): Protocol for a Single-Arm Community-Based Trial to Assess Feasibility and Acceptability in a Real-World Setting. JMIR Res Protoc. 2020 Sep 11;9(9):e18051. doi: 10.2196/18051. |
| 32773383 | Derived | Hill BJ, Motley DN, Rosentel K, VandeVusse A, Garofalo R, Schneider JA, Kuhns LM, Kipke MD, Reisner S, Rupp BM, Sanchez M, McCumber M, Renshaw L, Loop MS. An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 1): Protocol for Determining Essential Intervention Components Using Qualitative Interviews and Focus Groups. JMIR Res Protoc. 2020 Aug 10;9(8):e16384. doi: 10.2196/16384. |
| 32773376 | Derived | Hill BJ, Motley DN, Rosentel K, VandeVusse A, Garofalo R, Schneider JA, Kuhns LM, Kipke MD, Reisner S, Rupp BM, Sanchez M, McCumber M, Renshaw L, West Goolsby R, Loop MS. An Employment Intervention Program (Work2Prevent) for Young Men Who Have Sex With Men and Transgender Youth of Color (Phase 2): Protocol for a Single-Arm Mixed Methods Pilot Test to Assess Feasibility and Acceptability. JMIR Res Protoc. 2020 Aug 10;9(8):e16401. doi: 10.2196/16401. |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | self-identity; all individuals were assigned male sex at birth. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | United States, Chicago | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Employment Status | Count of Participants | Participants |
|
| Job Seeking Self-Efficacy 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. | Median | Inter-Quartile Range | units on a scale |
|
| Baseline HIV Test Result | Phase 3 participants who reported positive HIV status at baseline were not tested. | Count of Participants | Participants |
|
| Self-Reported Sexual Risk Behaviors | Note that Self-Reported Sexual Risk Behaviors are not mutually exclusive categories. Abbreviations: CAI, Condomless anal intercourse; STI, sexually transmitted infection. | Number | Number of events |
|
| Number of Self-Reported Sexual Risk Behaviors | Count of Participants | Participants |
|
| OG001 | Phase 3 | Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period. |
|
|
| 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. | The analysis population consists of participants who completed at least one workshop and/or the 8-month follow-up visit. | Posted | Count of Participants | Participants | Post-Intervention (up to 2 weeks after completion of intervention) |
|
|
|
| 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). | 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. | Posted | Mean | 90% Confidence Interval | units on a scale | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
|
|
|
|
| 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). | 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. | Posted | Mean | 90% Confidence Interval | units on a scale | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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| 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). | 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. | Posted | Mean | 90% Confidence Interval | hours/week | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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|
|
| 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:
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). | 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. | Posted | Mean | 90% Confidence Interval | sexual risk factors | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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| 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. | 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. | Posted | Count of Participants | Participants | No | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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| 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. | 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. | Posted | Count of Participants | Participants | Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
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| 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:
Number of yes responses at baseline and follow-up will be calculated. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
|
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| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
|
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|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline, Follow-Up (8 months for Phase 2, 3 months for Phase 3) |
|
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Phase 3 | Phase 3 utilizes a single-arm design, the intervention consists of four workshop sessions held over a two-day period. | 0 | 41 | 0 | 41 | 0 | 41 |
Not provided
Not provided
| Wilcoxon Signed Rank |
| 0.05 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted. |
| Wilcoxon Signed Rank |
| 0.76 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted. |
| Wilcoxon Signed Rank |
| 0.02 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted. |
| Wilcoxon Signed Rank |
| 0.17 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample non-parametric test for change between baseline and 3-month follow-up was conducted. |
| Other |
A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts. |
| 0.50 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample test for change between baseline and 3-month follow-up was conducted. |
| 1.00 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample test for change between baseline and 3-month follow-up was conducted. |
| 0.25 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample test for change between baseline and 3-month follow-up was conducted. |
| 1.00 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample test for change between baseline and 3-month follow-up was conducted. |
| Other |
A one-sample McNemar's test for change between baseline and 3-month follow-up was planned. The a priori threshold for statistical significance was set at 0.10. However, McNemar's test statistic could not be calculated due to small cell counts. |
| 1.00 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample test for change between baseline and 3-month follow-up was conducted. |
| 0.75 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample test for change between baseline and 3-month follow-up was conducted. |
| 1.00 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample test for change between baseline and 3-month follow-up was conducted. |
| 0.07 |
The a priori threshold for statistical significance was set at 0.10. This p-value was not adjusted for multiple comparisons. |
| Other |
A one-sample test for change between baseline and 3-month follow-up was conducted. |