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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

ConditionsHIV TestingPrEP Uptake
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-65
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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);

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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.

  • TRUST

    Behavioral

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

  • SOC

    Behavioral

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

Treatment groups

480 Participants
are divided into 4 treatment groups
Group A: A. SOCActive comparator 1 intervention
Group B: B. SOC & TRUSTExperimental treatment 2 interventions
Group C: C. SOC & DIYExperimental treatment 2 interventions
Group D: D. SOC, TRUST & DIYExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

P3M HIV testing

did the participant engage in HIV testing in the past 3 months

Time frame
past 3 months
2

PrEP uptake

PrEP uptake (yes/no)/time to PrEP uptake (assessed via self-report, medical record)

Time frame
past 3 months

Secondary outcomes

1

consistent HIV testing

consistent HIV testing (2+ tests 3 months apart in 9 months)

Time frame
over 9 months
2

PEP uptake

PEP uptake (self-report, medical record)

Time frame
past 3 months
3

PrEP and PEP adherence

PrEP/PEP adherence (self-report/medical record)

Time frame
past 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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