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

Human Immunodeficiency Virus (HIV) Clinical Trial

— SPARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037594
• Other study ID #: 349555-6
• Secondary ID: R01AA022067
• Status: Completed
• Phase: N/A
• Start date: January 30, 2014
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2018
• Source: Hunter College of City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Callen-Lorde Community Health Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Hunter College of City University of New York	Gilead Sciences, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP Uptake	Whether or not the patient decides to take PrEP	BL through 3-months
Primary	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
Primary	PrEP Adherence	Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.	BL through 12 months
Primary	Sexual Risk Behavior	Measured through STI testing and self-report.	BL through 12-months

External Links

•   Study Website