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

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ClinicalTrials.gov Identifier: NCT02037594
Recruitment Status : Active, not recruiting
First Posted : January 16, 2014
Last Update Posted : January 5, 2018
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Gilead Sciences
Information provided by (Responsible Party):
Sarit Golub, Hunter College of City University of New York

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
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) Not Applicable

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 Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
Actual Study Start Date : January 30, 2014
Actual Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. PrEP Uptake [ Time Frame: BL through 3-months ]
    Whether or not the patient decides to take PrEP

  2. PrEP Persistence [ Time Frame: BL through 12-months ]
    Whether or not patients who decide to take PrEP persist with the medication for the duration of the study.

  3. PrEP Adherence [ Time Frame: BL through 12 months ]
    Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.

  4. Sexual Risk Behavior [ Time Frame: BL through 12-months ]
    Measured through STI testing and self-report.


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037594


Locations
United States, New York
Callen-Lorde Community Health Center
New York, New York, United States, 10011
Sponsors and Collaborators
Hunter College of City University of New York
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Gilead Sciences
Investigators
Principal Investigator: Sarit A Golub, PhD, MPH Hunter College, CUNY
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Study Website  This link exits the ClinicalTrials.gov site

Responsible Party: Sarit Golub, Associate Professor, Hunter College of City University of New York
ClinicalTrials.gov Identifier: NCT02037594     History of Changes
Other Study ID Numbers: 349555-6
R01AA022067 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by Sarit Golub, Hunter College of City University of New York:
HIV
Pre-exposure prophylaxis
PrEP
MSM
Demonstration Project

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