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

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.

Study Overview

• Status: Completed
• Conditions: Human Immunodeficiency Virus (HIV)
• Intervention / Treatment: Behavioral: Sexual Health Counseling; Behavioral: Standard of Care Adherence Support (Active Control); Behavioral: Enhanced Adherence Intervention; Behavioral: PrEP Information (Active Control)

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.

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10011
      • Callen-Lorde Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hunter College of City University of New York
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Gilead Sciences
• Investigators: Principal Investigator: Sarit A Golub, PhD, MPH, Hunter College, CUNY

Publications and helpful links

Helpful Links

• Study Website

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2014
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (ESTIMATE): January 16, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: HIV; PrEP; MSM; Pre-exposure prophylaxis; Demonstration Project
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 349555-6; R01AA022067 (NIH)