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Completed

NCT Number: NCT02037594

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sexual Health Counseling

Behavioral

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.

Enhanced Adherence Intervention

Behavioral

This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.

PrEP Information (Active Control)

Behavioral

Standard of Care Information about PrEP

Standard of Care Adherence Support (Active Control)

Behavioral

Standard of care information and instruction about PrEP adherence.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • Gilead Sciences
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: SPARK

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Jan 16, 2014
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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