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

Hunter College of City University of New York

Status: Completed

Conditions: Human Immunodeficiency Virus (HIV)

Treatments: Behavioral: PrEP Information (Active Control); Behavioral: Standard of Care Adherence Support (Active Control); Behavioral: Sexual Health Counseling; Behavioral: Enhanced Adherence Intervention

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT02037594

R01AA022067 (U.S. NIH Grant/Contract)

349555-6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 438 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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438 participants in 4 patient groups

Counseling + SOC Adherence

Experimental group

Description:

Sexual Health Counseling followed by Standard of Care Adherence Support

Treatment:

Behavioral: Standard of Care Adherence Support (Active Control)

Behavioral: Sexual Health Counseling

Counseling + Enhanced Adherence

Experimental group

Description:

Sexual Health Counseling followed by Enhanced Adherence Intervention

Treatment:

Behavioral: Sexual Health Counseling

Behavioral: Enhanced Adherence Intervention

Information + SOC Adherence

Experimental group

Description:

PrEP Information followed by Standard of Care Adherence Support

Treatment:

Behavioral: Standard of Care Adherence Support (Active Control)

Behavioral: PrEP Information (Active Control)

Information + Enhanced Adherence

Experimental group

Description:

PrEP Information followed by Enhanced Adherence Intervention

Treatment:

Behavioral: Enhanced Adherence Intervention

Behavioral: PrEP Information (Active Control)