Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
- Conditions
- Human Immunodeficiency Virus (HIV)
- Interventions
- Behavioral: PrEP Information (Active Control)Behavioral: Sexual Health CounselingBehavioral: Enhanced Adherence InterventionBehavioral: Standard of Care Adherence Support (Active Control)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 438
- 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
- Past history of PrEP use or currently taking PrEP
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Counseling + Enhanced Adherence Enhanced Adherence Intervention Sexual Health Counseling followed by Enhanced Adherence Intervention Information + SOC Adherence PrEP Information (Active Control) PrEP Information followed by Standard of Care Adherence Support Counseling + SOC Adherence Sexual Health Counseling Sexual Health Counseling followed by Standard of Care Adherence Support Counseling + Enhanced Adherence Sexual Health Counseling Sexual Health Counseling followed by Enhanced Adherence Intervention Information + Enhanced Adherence PrEP Information (Active Control) PrEP Information followed by Enhanced Adherence Intervention Counseling + SOC Adherence Standard of Care Adherence Support (Active Control) Sexual Health Counseling followed by Standard of Care Adherence Support Information + SOC Adherence Standard of Care Adherence Support (Active Control) PrEP Information followed by Standard of Care Adherence Support Information + Enhanced Adherence Enhanced Adherence Intervention PrEP Information followed by Enhanced Adherence Intervention
- Primary Outcome Measures
Name Time Method 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 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 Adherence BL through 12 months Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Callen-Lorde Community Health Center
🇺🇸New York, New York, United States
Callen-Lorde Community Health Center🇺🇸New York, New York, United States