Overview

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)
Sponsor Hunter College
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Sexual Health Counseling followed by Standard of Care Adherence Support
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.
standard of care adherence support (active control)
Standard of care information and instruction about PrEP adherence.
(Experimental)
Sexual Health Counseling followed by Enhanced Adherence Intervention
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.
enhanced adherence intervention
This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
(Experimental)
PrEP Information followed by Standard of Care Adherence Support
prep information (active control)
Standard of Care Information about PrEP
standard of care adherence support (active control)
Standard of care information and instruction about PrEP adherence.
(Experimental)
PrEP Information followed by Enhanced Adherence Intervention
enhanced adherence intervention
This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
prep information (active control)
Standard of Care Information about PrEP

Primary Outcomes

Measure
PrEP Uptake
time frame: BL through 3-months
PrEP Persistence
time frame: BL through 12-months
PrEP Adherence
time frame: BL through 12 months
Sexual Risk Behavior
time frame: BL through 12-months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hunter College.