Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus (HIV)

• Registration Number: NCT02037594
• Lead Sponsor: Hunter College of City University of New York

Brief Summary

This study identifies social and behavioral factors likely to influence PrEP acceptability and adherence among men who have sex with men (MSM), and collaborates with a community health center to evaluate a two-stage intervention to improve PrEP decision-making, as well as persistence and adherence for those who chose to take PrEP.

Detailed Description

Pre-exposure prophylaxis (PrEP) refers to daily or intermittent oral administration of antiretroviral drugs designed to protect high-risk HIV-negative individuals from infection. In order for PrEP to become an effective prevention tool, three critical factors must be addressed: a) acceptability, i.e., individuals who would benefit from PrEP must know about it and be willing to take it; b) adherence, i.e., individuals who choose to PrEP as a prevention strategy must take the pills as prescribed; and c) implementation, i.e., processes and protocols must be developed to allow for the integration of PrEP delivery and programs into real world settings in a way that is feasible, scalable, and realistic. This project has three specific aims: 1) Identifying social and behavioral factors that are likely to influence PrEP implementation, acceptance, and use/adherence by men who have sex with men (MSM) in NYC, including factors at individual-, community-, and organizational-levels; 2) Examining social and behavioral factors associated with disparities in access to prevention and care services among MSM in NYC that might directly impact PrEP implementation programs and policies; and 3) Evaluating an intervention in which PrEP is introduced, provided, and supported as part of a prevention package delivered in an community health center. The project has the potential to exert a sustained and powerful influence not only on the effectiveness of PrEP interventions for MSM, but also on dissemination and scalability of a targeted intervention within community-based settings and in a manner that reduces disparities in access and maximizes cultural competence and acceptability.

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Study Start: 2014-01-30
• Primary Completion: 2017-06-01
• Study Completion: 2018-06-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 438

Inclusion Criteria

• Registered patient receiving medical or health services at Callen-Lorde Community Health Center
• Male sex (at birth) and reported sex with men or transwomen
• At least 18 years of age
• HIV-negative
• At risk for HIV acquisition

Exclusion Criteria

• Past history of PrEP use or currently taking PrEP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
PrEP Uptake	BL through 3-months	Whether or not the patient decides to take PrEP
Sexual Risk Behavior	BL through 12-months	Measured through STI testing and self-report.
PrEP Persistence	BL through 12-months	Whether or not patients who decide to take PrEP persist with the medication for the duration of the study.
PrEP Adherence	BL through 12 months	Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.

Trial Locations

Locations (1)

Callen-Lorde Community Health Center; 🇺🇸 New York, New York, United States