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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2025-01-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2028-02-28
Completion
2028-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06785376 on ClinicalTrials.gov