Clinical trial NCT06785376: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Testing
PrEP Uptake
Keywords: HIV testing
PrEP uptake
HIV prevention
men who have sex with men
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-01-21
Enrollment: 480
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. assigned biological male sex at birth;
2. 18-65 years of age;
3. self-identify as: Black, African-American, Afro-Caribbean, Black African, Afro-Latino or multiethnic Black;
4. 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

Primary outcomes:
measure: P3M HIV testing
timeFrame: past 3 months
measure: PrEP uptake
timeFrame: past 3 months
Secondary outcomes:
measure: consistent HIV testing
timeFrame: over 9 months
measure: PEP uptake
timeFrame: past 3 months
measure: PrEP and PEP adherence
timeFrame: past 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
References: