P3 Trial: Estimating the Impact of a Multilevel, Multicomponent Intervention to Increase Uptake of HIV Testing and Biomedical HIV Prevention Among African-American/Black Gay, Bisexual, and Same-gender Loving Men
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DIY (Do It Yourself), TRUST, SOC.
- Who it may be relevant to
- Registry conditions: HIV Testing, PrEP Uptake. Basic parameters: 18 years — 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Estimating the Impact of a Multilevel, Multicomponent Intervention to Increase Uptake of HIV Testing and Biomedical HIV Prevention Among African-American/Black Gay, Bisexual and Same-gender Loving Men
Overview
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.
Detailed description
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:
1. 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. 2. 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. 3. 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.
Interventions
- Behavioral DIY (Do It Yourself)
DIY is 3-session program that promotes empowerment, autonomy, stigma coping/resistance and social support to promote sexual health and pleasure and HIV prevention. - Behavioral TRUST
TRUST is a single-session HIV self-testing training with facilitator - Behavioral SOC
standard of care single-session, low threshold peer/near-peer navigation to PrEP.
Primary outcome measures
- P3M HIV testing [Time frame: past 3 months]
- PrEP uptake [Time frame: past 3 months]
Secondary outcome measures (3)
- consistent HIV testing [Time frame: over 9 months]
- PEP uptake [Time frame: past 3 months]
- PrEP and PEP adherence [Time frame: past 3 months]
Eligibility criteria
Inclusion criteria
- assigned biological male sex at birth;
- 18-65 years of age;
- self-identify as: Black, African-American, Afro-Caribbean, Black African, Afro-Latino or multiethnic Black;
- reside in the NYC metro area; (5) not HIV-positive (tested before randomization);
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
- Sexual identity is not an exclusion criterion
- potential participants who self-identify as Latino must also identify as Black (as per above) to be included
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Columbia University — New York
Publications
- 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. PMID 41995922
Identifiers
NCT: NCT06785376 · AAAU8754 · R01MH129198