Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
This trial is active, not recruiting.
|Condition||human immunodeficiency virus (hiv)|
|Treatments||sexual health counseling, enhanced adherence intervention, prep information (active control), standard of care adherence support (active control)|
|Collaborator||National Institute on Alcohol Abuse and Alcoholism (NIAAA)|
|Start date||January 2014|
|End date||June 2017|
|Trial size||445 participants|
|Trial identifier||NCT02037594, 349555-6, R01AA022067|
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.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
time frame: BL through 3-months
time frame: BL through 12-months
time frame: BL through 12 months
Sexual Risk Behavior
time frame: BL through 12-months
Male participants at least 18 years old.
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
|Official title||Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting|
|Principal investigator||Sarit A Golub, PhD, MPH|
|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.|
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