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

NCT06785376 | Recruiting DMC

• 2 other identifiers: AAAU8754R01MH129198
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Testing; PrEP Uptake

Keywords

HIV testing; PrEP uptake; HIV prevention; men who have sex with men

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• consistent HIV testing

  over 9 months

• PEP uptake

  past 3 months

• PrEP and PEP adherence

  past 3 months

Study Arms (4)

A. SOC

ACTIVE COMPARATOR

A. standard of care single-session, low threshold peer/near-peer navigation to PrEP.

Behavioral: SOC

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

Behavioral: TRUST; Behavioral: SOC

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

Behavioral: DIY (Do It Yourself); Behavioral: SOC

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

Behavioral: DIY (Do It Yourself); Behavioral: TRUST; Behavioral: SOC

Interventions

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.

C. SOC & DIY; D. SOC, TRUST & DIY

TRUST BEHAVIORAL

TRUST is a single-session HIV self-testing training with facilitator

B. SOC & TRUST; D. SOC, TRUST & DIY

SOC BEHAVIORAL

standard of care single-session, low threshold peer/near-peer navigation to PrEP.

A. SOC; B. SOC & TRUST; C. SOC & DIY; D. SOC, TRUST & DIY

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• assigned biological male sex at birth;
• 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);
• \) 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.

You may not qualify if:

• potential participants who self-identify as Latino must also identify as Black (as per above) to be included

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Columbia University

New York, New York, 10027, United States

RECRUITING

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior

Central Study Contacts

Victoria Frye, MPH, DrPH

CONTACT

2128534490; vaf5@columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 21, 2025
• Study Start: December 19, 2024
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: January 21, 2025

Record last verified: 2025-01

Locations

US (1)