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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hunter College
Sponsor:
Collaborators:
Gilead Sciences
Information provided by (Responsible Party):
Sarit Golub, Hunter College
ClinicalTrials.gov Identifier:
NCT02037594
First received: January 14, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

January 14, 2014
January 14, 2014
January 2014
June 2017   (final data collection date for primary outcome measure)
  • PrEP Uptake [ Time Frame: BL through 3-months ] [ Designated as safety issue: No ]
    Whether or not the patient decides to take PrEP
  • PrEP Persistence [ Time Frame: BL through 12-months ] [ Designated as safety issue: No ]
    Whether or not patients who decide to take PrEP persist with the medication for the duration of the study.
  • PrEP Adherence [ Time Frame: BL through 12 months ] [ Designated as safety issue: No ]
    Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.
  • Sexual Risk Behavior [ Time Frame: BL through 12-months ] [ Designated as safety issue: No ]
    Measured through STI testing and self-report.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Human Immunodeficiency Virus (HIV)
  • 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.
  • Behavioral: PrEP Information (Active Control)
    Standard of Care Information about PrEP
  • Behavioral: Standard of Care Adherence Support (Active Control)
    Standard of care information and instruction about PrEP adherence.
  • Experimental: Counseling + SOC Adherence
    Sexual Health Counseling followed by Standard of Care Adherence Support
    Interventions:
    • Behavioral: Sexual Health Counseling
    • Behavioral: Standard of Care Adherence Support (Active Control)
  • Experimental: Counseling + Enhanced Adherence
    Sexual Health Counseling followed by Enhanced Adherence Intervention
    Interventions:
    • Behavioral: Sexual Health Counseling
    • Behavioral: Enhanced Adherence Intervention
  • Experimental: Information + SOC Adherence
    PrEP Information followed by Standard of Care Adherence Support
    Interventions:
    • Behavioral: PrEP Information (Active Control)
    • Behavioral: Standard of Care Adherence Support (Active Control)
  • Experimental: Information + Enhanced Adherence
    PrEP Information followed by Enhanced Adherence Intervention
    Interventions:
    • Behavioral: Enhanced Adherence Intervention
    • Behavioral: PrEP Information (Active Control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
445
July 2017
June 2017   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact: Sarit A Golub, PhD, MPH 212-396-6304 sgolub@hunter.cuny.edu
Contact: Amy M Hilley, MPH 212-271-7200 ext 7418 ahilley@callen-lorde.org
United States
 
NCT02037594
349555-6, R01AA022067
Yes
Sarit Golub, Hunter College
Hunter College
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Gilead Sciences
Principal Investigator: Sarit A Golub, PhD, MPH Hunter College, CUNY
Hunter College
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP