Recruiting

HIV Testing

Sponsor:

Columbia University

Code:

NCT06785376

Conditions

HIV Testing

PrEP Uptake

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

DIY (Do It Yourself)

TRUST

SOC

Study Details

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

Study ID

NCT06785376

Start date

Dec 19, 2024

Status verified date

Aug, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 65

Healthy Volunteers: Accepted

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
  • Not HIV-positive (tested before randomization)
  • Report insertive or receptive anal intercourse with another man in the past six months
  • Not currently on PEP or PrEP
  • Can communicate in English or Spanish
  • Provide informed consent for the study
  • Any sexual identity

Exclusion Criteria:

  • Unable to conduct a rapid HIV-self test to confirm self-reported HIV-negative status

Study Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: A. SOC

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

experimental: B. SOC & TRUST

SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; TRUST single-session HIV self-testing training with facilitator

experimental: C. SOC & DIY

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

experimental: D. SOC, TRUST & DIY

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

Interventions

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.

TRUST

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

SOC

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

Primary outcome measure

  • P3M HIV testing [ Time Frame: past 3 months ]
  • PrEP uptake [ Time Frame: past 3 months ]

Central Contacts and Locations

Central contacts

Victoria Frye, MPH, DrPH

2128534490vaf5@columbia.edu

Locations

Columbia University

Recruiting

New York, New York, United States, 10027

Contacts

Victoria Frye, MPH, DrPH

2128534490vaf5@columbia.edu

Principal Investigator:

Victoria Frye, MPH, DrPH

More Information

Sponsor

Columbia University

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-08-31.