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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH129198 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The major goal of this study is to evaluate a multi-component, multilevel HIV prevention intervention that targets theoretically-informed and empirically-identified barriers to and facilitators of both HIV testing and PEP/PrEP uptake by combining existing evidence-based and novel evidence-informed components and integrating them into a community-based organization's (CBO) standard of care (SOC) PEP/PrEP navigation program. The evaluation will apply use a 2x2 factorial design to randomize and follow for 18 months 480 PrEP-eligible Black MSM (aged 18-65) living in the NYC area to one of four combinations of interventions. The impact of the social/media campaign, delivered to both geographic (print media) and Black MSM communities (social media) and launched midway through recruitment, will be assessed through assessment of timing and length of exposure as covariates in analysis.
The major goal of this study is to evaluate a multi-component, multilevel HIV prevention intervention that targets theoretically-informed and empirically-identified barriers to and facilitators of both HIV testing and PEP/PrEP uptake by combining existing evidence-based and novel evidence-informed components and integrating them into a community-based organization's (CBO) standard of care (SOC) PEP/PrEP navigation program. The existing evidence-based, individual-level component is TRUST (R01 DA-038108), a single-session peer-based HIV self-testing intervention for Black MSM. The existing, evidence-based community-level component is a social/print media campaign (CHHANGE [R21 MH-102182-01] & PEPTALK [R21 AI-122996]) to reduce community-level HIV stigma and drive demand for HIV testing, PEP and PrEP. The novel, evidence-informed, individual-level component is "Do It Yourself (DIY)", a 3-session enhancement of the CBO SOC peer navigation program that promotes empowerment, autonomy, stigma coping/resistance and social support via a novel "sexual self-care in-a-box" and peer-to-peer training to increase HIV testing and PEP/PrEP uptake.
The Specific Aims are:
Component test DIY, adapt social/print media campaign & manualize full intervention. We will conduct modified intervention mapping, component testing and post-test interviews with 20 PrEP-eligible Black MSM (for DIY) and focus groups with 20 PrEP-eligible Black MSM (for media campaign adaptation). A 15-person community consulting group of Black MSM, community leaders, media professionals, and service providers, will provide feedback on both components and the full manualized intervention.
Estimate main and interactive effects of components on recent HIV testing and PEP/PrEP uptake.
H1: Exposure to TRUST, DIY, and the media campaign will each be associated with (1) higher past 3-month HIV testing; and (2) shorter time to PrEP uptake over time.
H2: A multiplicative interaction among TRUST, DIY and length of exposure to the media campaign will emerge, such that exposure to combination of multiple interventions will be associated with the more positive outcomes compared to the impact of each intervention component individually.
Primary outcomes: (1) HIV testing in past 3 months; (2) time to PrEP uptake: assessed via self-report, medical record, urine test (UrSure, qualitative, visually-read point of care test [validated machine analysis] measuring adherence to tenofovir, metabolite of tenofovir disopropil fumarate (TDF) and tenofovir alafenamide (TAF) via lateral flow immunoassay). Secondary outcomes:
consistent HIV testing (2+ tests 3 months apart in 9 months), PEP uptake (self-report, medical record), PrEP/PEP adherence (self-report/ medical record/urine test). To test hypotheses, we will use a 2x2 factorial design to randomize and follow for 18 months 480 PrEP-eligible Black MSM (aged 18-65) living in NYC to one of four combinations: 1) SOC, DIY & TRUST; 2) SOC & TRUST (no DIY); 3) SOC & DIY (no TRUST); 4) SOC ALONE (no TRUST and no DIY). Hypotheses will be tested via regression (GEE) and Cox proportional hazard models; impact of the social/media campaign, delivered to both geographic (print media) and Black MSM communities (social media) and launched midway through recruitment, will be assessed through assessment of timing and length of exposure as covariates in the regression models and through interrupted time series methods.
Describe the feasibility, acceptability, and usability of intervention components and package via the Re-AIM implementation framework with an emphasis on component implementation by a CBO program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A. SOC | Active Comparator | A. standard of care single-session, low threshold peer/near-peer navigation to PrEP. |
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| B. SOC & TRUST | Experimental | B. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; TRUST single-session HIV self-testing training with facilitator |
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| C. SOC & DIY | Experimental | C. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; DIY three-session sexual health promotion/HIV prevention training with facilitator |
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| D. SOC, TRUST & DIY | Experimental | D. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; TRUST single-session HIV self-testing training with facilitator; DIY three-session sexual health promotion/HIV prevention training with facilitator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DIY (Do It Yourself) | Behavioral | DIY is 3-session program that promotes empowerment, autonomy, stigma coping/resistance and social support to promote sexual health and pleasure and HIV prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| P3M HIV testing | did the participant engage in HIV testing in the past 3 months | past 3 months |
| PrEP uptake | PrEP uptake (yes/no)/time to PrEP uptake (assessed via self-report, medical record) | past 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| consistent HIV testing | consistent HIV testing (2+ tests 3 months apart in 9 months) | over 9 months |
| PEP uptake | PEP uptake (self-report, medical record) |
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Inclusion Criteria:
6) report insertive or receptive anal intercourse with another man in the past six months; 7) not currently on PEP or PrEP; 8) communicate in English or Spanish; 9) provide informed consent for the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Frye, MPH, DrPH | Contact | 2128534490 | vaf5@columbia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University | Recruiting | New York | New York | 10027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41995922 | Derived | Bond KT, Williams PM, Paige M, Lam I, Hart K, Matthews D, Smith W, Koffler E, Zhang H, Kelvin EA, Frye V, Duncan DT. Designing Pleasure-Centered, Culturally Relevant PrEP Messaging for Black Gay, Bisexual, Queer, Same-Gender-Loving, and Other Men Who have Sex with Men (SGL/MSM) in New York City. AIDS Behav. 2026 Apr 17. doi: 10.1007/s10461-026-05077-7. Online ahead of print. |
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A 2x2 factorial design to randomize and follow for 18 months 480 PrEP-eligible Black MSM (aged 18-65) living in the NYC area to one of four combinations: 1) SOC, DIY & TRUST; 2) SOC & TRUST (no DIY); 3) SOC & DIY (no TRUST); 4) SOC ALONE (no TRUST and no DIY). Hypotheses will be tested via regression (GEE) and Cox proportional hazard models; impact of the social/media campaign, delivered to both geographic (print media) and Black MSM communities (social media) and launched midway through recruitment, will be assessed through assessment of timing and length of exposure as covariates in the regression models and through interrupted time series methods.
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We will endeavor to mask assignment with participants. It is possible (likely) that word will spread among networks of participants which arm is which. They of course are informed about the varying conditions/arms and that there are different numbers of sessions in each, but the exact "arm" is not disclosed to participants.
| TRUST | Behavioral | TRUST is a single-session HIV self-testing training with facilitator |
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| SOC | Behavioral | standard of care single-session, low threshold peer/near-peer navigation to PrEP. |
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| past 3 months |
| PrEP and PEP adherence | PrEP/PEP adherence (self-report/medical record) | past 3 months |
| ID | Term |
|---|---|
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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