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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
  Purpose

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.


Condition Intervention
Human Immunodeficiency Virus (HIV)
Behavioral: Sexual Health Counseling
Behavioral: Enhanced Adherence Intervention
Behavioral: PrEP Information (Active Control)
Behavioral: Standard of Care Adherence Support (Active Control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting

Resource links provided by NLM:


Further study details as provided by Hunter College:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 445
Study Start Date: January 2014
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037594

Contacts
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

Locations
United States, New York
Callen-Lorde Community Health Center Recruiting
New York, New York, United States, 10011
Contact: Amy Hilley, MPH    212-271-7200 ext 7418    ahilley@callen-lorde.org   
Contact: Sarit A Golub, PhD, MPH    212-396-6305    sgolub@hunter.cuny.edu   
Principal Investigator: Anita Radix, MD         
Sponsors and Collaborators
Hunter College
Gilead Sciences
Investigators
Principal Investigator: Sarit A Golub, PhD, MPH Hunter College, CUNY
  More Information

Additional Information:
No publications provided

Responsible Party: Sarit Golub, Associate Professor, Hunter College
ClinicalTrials.gov Identifier: NCT02037594     History of Changes
Other Study ID Numbers: 349555-6, R01AA022067
Study First Received: January 14, 2014
Last Updated: January 14, 2014
Health Authority: United States: CUNY University Integrated Institutional Review Board

Keywords provided by Hunter College:
HIV
Pre-exposure prophylaxis
PrEP
MSM
Demonstration Project

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 24, 2014