Clinical trial NCT04329442: Accelerated PrEP Access for Black MSM and TW
Official title: Point of Care PrEP Delivery for Young Black/African American Men Who Have Sex With Men and Young Transgender Women at High Risk for HIV Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV/AIDS
Keywords: PrEP
HIV Prevention
Young Men Who Have Sex with Men
Young Transgender Women
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Great Plains
First posted: 2020-04-01
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm longitudinal pre/post study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intention to Continue PrEP
timeFrame: Post Intervention (1 month after receiving intervention)
measure: Intention to Continue PrEP
timeFrame: Post Intervention (4 months after receiving intervention)
measure: PrEP Adherence
timeFrame: Post Intervention (1 month after receiving intervention)
measure: PrEP Adherence
timeFrame: Post Intervention (4 months after receiving intervention)
Secondary outcomes:
measure: PrEP Adherence Self-Efficacy
timeFrame: Post Intervention (1 month after receiving intervention)
measure: PrEP Adherence Self-Efficacy
timeFrame: Post Intervention (4 months after receiving intervention)
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: Darnell N Motley, PhD
role: STUDY_DIRECTOR
References: