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

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sexual Health Counseling
Enhanced Adherence Intervention
PrEP Information (Active Control)
Standard of Care Adherence Support (Active Control)
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) focused on measuring HIV, Pre-exposure prophylaxis, PrEP, MSM, Demonstration Project

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Callen-Lorde Community Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Counseling + SOC Adherence

Counseling + Enhanced Adherence

Information + SOC Adherence

Information + Enhanced Adherence

Arm Description

Sexual Health Counseling followed by Standard of Care Adherence Support

Sexual Health Counseling followed by Enhanced Adherence Intervention

PrEP Information followed by Standard of Care Adherence Support

PrEP Information followed by Enhanced Adherence Intervention

Outcomes

Primary Outcome Measures

PrEP Uptake
Whether or not the patient decides to take PrEP
PrEP Persistence
Whether or not patients who decide to take PrEP persist with the medication for the duration of the study.
PrEP Adherence
Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.
Sexual Risk Behavior
Measured through STI testing and self-report.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2014
Last Updated
October 9, 2018
Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02037594
Brief Title
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
Acronym
SPARK
Official Title
Intervention to Enhance PrEP Uptake and Adherence in a Community-Based Setting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2014 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
Keywords
HIV, Pre-exposure prophylaxis, PrEP, MSM, Demonstration Project

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Counseling + SOC Adherence
Arm Type
Experimental
Arm Description
Sexual Health Counseling followed by Standard of Care Adherence Support
Arm Title
Counseling + Enhanced Adherence
Arm Type
Experimental
Arm Description
Sexual Health Counseling followed by Enhanced Adherence Intervention
Arm Title
Information + SOC Adherence
Arm Type
Experimental
Arm Description
PrEP Information followed by Standard of Care Adherence Support
Arm Title
Information + Enhanced Adherence
Arm Type
Experimental
Arm Description
PrEP Information followed by Enhanced Adherence Intervention
Intervention Type
Behavioral
Intervention Name(s)
Sexual Health Counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Adherence Intervention
Intervention Description
This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
Intervention Type
Behavioral
Intervention Name(s)
PrEP Information (Active Control)
Intervention Description
Standard of Care Information about PrEP
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Adherence Support (Active Control)
Intervention Description
Standard of care information and instruction about PrEP adherence.
Primary Outcome Measure Information:
Title
PrEP Uptake
Description
Whether or not the patient decides to take PrEP
Time Frame
BL through 3-months
Title
PrEP Persistence
Description
Whether or not patients who decide to take PrEP persist with the medication for the duration of the study.
Time Frame
BL through 12-months
Title
PrEP Adherence
Description
Biological measure of medication adherence using dried blood spots, and self-report measure of adherence using VAS.
Time Frame
BL through 12 months
Title
Sexual Risk Behavior
Description
Measured through STI testing and self-report.
Time Frame
BL through 12-months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarit A Golub, PhD, MPH
Organizational Affiliation
Hunter College, CUNY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Callen-Lorde Community Health Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cunyhart.org/spark
Description
Study Website

Learn more about this trial

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

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