Accelerated PrEP Access for Black MSM and TW

The University of Chicago

Status: Withdrawn

Conditions: HIV/AIDS

Treatments: Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04329442

IRB19-1154

Details and patient eligibility

About

The investigators will pilot-test an accelerated PrEP initiation approach among young high-risk Black/African American (B/AA) men who have sex with men (MSM) and transgender women (YMSM/TW) at the point of care in community contexts.

Full description

The study team will provide a free 30-day supply of HIV pre-exposure prophylaxis (PrEP) to young Black MSM and TW identified as PrEP-eligible and interested in taking PrEP to reduce their risk of HIV acquisition. This intervention is intended to assist youth at high risk for HIV acquisition in successfully initiating PrEP use.

Sex: Male

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. ages 18-24;
2. assigned male at birth, identify as a man (cisgender), transgender woman, or gender non-conforming or genderqueer;
3. identifying as Black, African American, or multiracial with at least one parent identifying as Black or African American;
4. not currently taking PrEP or attending a visit to initiate PrEP;
5. self-report being HIV-negative;
6. reporting one of the following HIV risks in the last 6 months (Hosek, Rudy et al. 2015, Hosek, Rudy et al. 2017): a. condomless anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status; b. anal intercourse with 3 or more male sex partners; c. exchange of money, gifts, shelter, or drugs for anal sex with a male partner; d. sex with a male partner and has had a sexually transmitted infection; e. sexual partner of an HIV-infected male with whom condoms were not consistently used; f. anal intercourse where the condom broke or slipped off

Exclusion criteria

• We are excluding those individuals who were assigned female at birth (female birth certificate) and/or cis-gender women (those assigned female at birth and identify as women) from the all phases of this study as this study is intended to explore the HIV prevention behaviors of B/AA young men who have sex with men and young transgender women (assigned male at birth) as these two groups represent the highest risk groups for HIV infection in the US, yet only a small percentage are aware or currently use PrEP for HIV prevention.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PrEP Received

Experimental group

Description:

Participants will be provided with a free 30-day supply of PrEP.

Treatment:

Drug: Emtricitabine / Tenofovir Disoproxil Oral Tablet