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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Human Immunodeficiency Virus (HIV)

Intervention / Treatment
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* Behavioral: Sexual Health Counseling
* Behavioral: Enhanced Adherence Intervention
* Behavioral: PrEP Information (Active Control)
* Behavioral: Standard of Care Adherence Support (Active Control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counseling + SOC Adherence<br>Sexual Health Counseling followed by Standard of Care Adherence Support | Behavioral: Sexual Health Counseling<br>* 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.<br>Behavioral: Standard of Care Adherence Support (Active Control)<br>* Standard of care information and instruction about PrEP adherence.<br>|
| Experimental: Counseling + Enhanced Adherence<br>Sexual Health Counseling followed by Enhanced Adherence Intervention | Behavioral: Sexual Health Counseling<br>* 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.<br>Behavioral: Enhanced Adherence Intervention<br>* This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.<br>|
| Experimental: Information + SOC Adherence<br>PrEP Information followed by Standard of Care Adherence Support | Behavioral: PrEP Information (Active Control)<br>* Standard of Care Information about PrEP<br>Behavioral: Standard of Care Adherence Support (Active Control)<br>* Standard of care information and instruction about PrEP adherence.<br>|
| Experimental: Information + Enhanced Adherence<br>PrEP Information followed by Enhanced Adherence Intervention | Behavioral: Enhanced Adherence Intervention<br>* This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.<br>Behavioral: PrEP Information (Active Control)<br>* Standard of Care Information about PrEP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Uptake | Whether or not the patient decides to take PrEP | BL through 3-months | 
| PrEP Persistence | Whether or not patients who decide to take PrEP persist with the medication for the duration of the study. | BL through 12-months | 
| PrEP Adherence | Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS. | BL through 12 months | 
| Sexual Risk Behavior | Measured through STI testing and self-report. | BL through 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Demonstration Project, Pre-exposure prophylaxis, PrEP, MSM