PrEP for Black MSM: Community-Based Ethnography and Clinic-Based Treatment
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 204
- Locations
- 2
- Primary Endpoint
- adherence to daily Truvada use
Study Overview
Brief Summary
Black men who have sex with men (MSM) have among the highest rates of new HIV infections of any group in the United States. Developing effective HIV prevention interventions that work with this group is a critical element of the National HIV/AIDS Strategy. In the first phase of our study ("the ethnographic phase"), the investigators will carry out community-based research that will explore structural, social and cultural factors relevant to how Black MSM might engage with Pre-Exposure Prophylaxis (PrEP). This phase of community-based research will inform the design of an enhanced PrEP adherence intervention, which will be subsequently tested at a community-based health clinic in Harlem in the second phase of the project.
Detailed Description
STUDY OBJECTIVES AND DESIGN This randomized clinical trial will enroll HIV-uninfected Black MSM and transgender females (TGF) and randomly assign them to receive enhanced versus standard PrEP adherence packages. Study participants will receive PrEP-related clinical care at Harlem United, a community-based healthcare provider in New York City's Central Harlem.
Primary Objective Compare the effectiveness of enhanced versus standard packages for increasing adherence to PrEP in a community-based primary care clinic
Secondary Objectives
- Compare the enhanced and standard PrEP adherence packages on:
- sexual risk behaviors
- retention in care
- PrEP knowledge
- seroconversions
- Examine the safety of PrEP among participants as measured by the type and frequency of adverse events
- Describe acceptability of daily PrEP among Black MSM and TGF generally and among those who have agreed to take PrEP
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •male at birth
- •self-identify as Black, African American, Caribbean Black, African, or multiethnic Black
- •are 18 years of age or older
- •any male or transgender woman (TGW) partners in past 6 months;
- •not in a monogamous partnership with a recently tested, HIV-negative man;
- •have at least one of the following:
- •reporting condomless anal and/or receptive neovaginal intercourse with at least one man or TGW in the past six months;
- •any STI diagnosed or reported in past 6 months;
- •is in on-going sexual relationship with an HIV-positive male or TGW partner;
- •able to provide written informed consent in English;
- •able to provide a street address or residence or phone number for themselves or two personal contacts who would know their whereabouts during participation in the study
Exclusion Criteria
- •current participation in any other PrEP study;
- •having taken PrEP in programmatic context more than 3 months
Arms & Interventions
Enhanced PrEP Adherence
Enhanced PrEP Adherence: peer navigators, PrEP support group, on-line support group, text message reminders
Intervention: Enhanced PrEP Adherence (Behavioral)
Standard PrEP Adherence
Standard PrEP Adherence: support groups, case management
Intervention: Standard PrEP Adherence (Behavioral)
Outcomes
Primary Outcomes
adherence to daily Truvada use
Time Frame: twelve months after enrollment
this is a measure of PrEP adherence, to be implemented through self-reported adherence and collection of dried blood spots
Secondary Outcomes
- number of participants remaining in care(end of 12-month study period)
- percentage of sexual acts where condom was used(twelve months after enrollment)
- number of correct knowledge items(twelve months after enrollment)
- positive HIV test(during 12-month study period)
Investigators
Paul Colson
Associate Research Scientist
Columbia University