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Clinical Trials/NCT04329442
NCT04329442
Withdrawn
Not Applicable

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

University of Chicago0 sitesApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Emtricitabine / Tenofovir Disoproxil Oral Tablet
Conditions
HIV/AIDS
Sponsor
University of Chicago
Primary Endpoint
Intention to Continue PrEP
Status
Withdrawn
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
July 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ages 18-24;
  • assigned male at birth, identify as a man (cisgender), transgender woman, or gender non-conforming or genderqueer;
  • identifying as Black, African American, or multiracial with at least one parent identifying as Black or African American;
  • not currently taking PrEP or attending a visit to initiate PrEP;
  • self-report being HIV-negative;
  • 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.

Arms & Interventions

PrEP Received

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

Intervention: Emtricitabine / Tenofovir Disoproxil Oral Tablet

Outcomes

Primary Outcomes

Intention to Continue PrEP

Time Frame: Post Intervention (4 months after receiving intervention)

Intention to continue use of PrEP will be assessed via survey questions related to a respondent having made a follow-up appointment to continue taking PrEP, attended an appointment to continue taking PrEP, having filled a prescription for PrEP, and reporting an interest in continuing PrEP after current supply is complete.

PrEP Adherence

Time Frame: Post Intervention (4 months after receiving intervention)

PrEP adherence will be assessed via self-report of how many pills from the initial intervention remain and a self-assessment of success at remembering to take PrEP daily.

Secondary Outcomes

  • PrEP Adherence Self-Efficacy(Post Intervention (4 months after receiving intervention))

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