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Clinical Trials/NCT02037594
NCT02037594
Completed
Not Applicable

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

Hunter College of City University of New York1 site in 1 country438 target enrollmentJanuary 30, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Immunodeficiency Virus (HIV)
Sponsor
Hunter College of City University of New York
Enrollment
438
Locations
1
Primary Endpoint
PrEP Uptake
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2014
End Date
June 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Male

Investigators

Sponsor
Hunter College of City University of New York
Responsible Party
Principal Investigator
Principal Investigator

Sarit Golub

Associate Professor

Hunter College of City University of New York

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

Outcomes

Primary Outcomes

PrEP Uptake

Time Frame: BL through 3-months

Whether or not the patient decides to take PrEP

Sexual Risk Behavior

Time Frame: BL through 12-months

Measured through STI testing and self-report.

PrEP Persistence

Time Frame: 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

Time Frame: BL through 12 months

Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.

Study Sites (1)

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