Clinical trial NCT02037594: Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
Official title: Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus (HIV)
Keywords: HIV
Pre-exposure prophylaxis
PrEP
MSM
Demonstration Project
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Gilead Sciences
First posted: 2014-01-16
Enrollment: 438
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: PrEP Uptake
timeFrame: BL through 3-months
measure: PrEP Persistence
timeFrame: BL through 12-months
measure: PrEP Adherence
timeFrame: BL through 12 months
measure: Sexual Risk Behavior
timeFrame: BL through 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Callen-Lorde Community Health Center
state: New York
Study officials:
affiliation: Hunter College, CUNY
name: Sarit A Golub, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: