Human Immunodeficiency Virus (HIV)
Conditions
Keywords
HIV, Pre-exposure prophylaxis, PrEP, MSM, Demonstration Project
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.
Interventions
BEHAVIORALSexual 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.
BEHAVIORALEnhanced Adherence Intervention
This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
BEHAVIORALPrEP Information (Active Control)
Standard of Care Information about PrEP
BEHAVIORALStandard of Care Adherence Support (Active Control)
Standard of care information and instruction about PrEP adherence.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Gilead Sciences
Hunter College of City University of New York
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Uptake | BL through 3-months | Whether or not the patient decides to take PrEP |
| 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 Adherence | BL through 12 months | Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS. |
| Sexual Risk Behavior | BL through 12-months | Measured through STI testing and self-report. |
Countries
United States
Outcome results
None listed