NCT02037594

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Hunter College of City University of New York · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Immunodeficiency Virus (HIV)

Interventions

Type	Name	Description
BEHAVIORAL	Sexual Health Counseling	This brief intervention presents PrEP within the context of a patient's comprehensive sexual health plan and is designed to enhance decision-making around PrEP use and decrease sexual risk taking.
BEHAVIORAL	Enhanced Adherence Intervention	This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
BEHAVIORAL	PrEP Information (Active Control)	Standard of Care Information about PrEP
BEHAVIORAL	Standard of Care Adherence Support (Active Control)	Standard of care information and instruction about PrEP adherence.

Timeline

• Start date: 2014-01-30
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2014-01-16
• Last updated: 2018-10-11

Locations

1 site across 1 country: United States