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

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 (Adult, Senior)
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

Locations


United States, New York
Callen-Lorde Community Health Center
New York, New York, United States, 10011

Sponsors and Collaborators

Hunter College

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Gilead Sciences

Investigators


Principal Investigator:	Sarit A Golub, PhD, MPH	Hunter College, CUNY

More Information

Additional Information:

Study Website This link exits the ClinicalTrials.gov site


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:	June 13, 2016
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:


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

ClinicalTrials.gov processed this record on September 23, 2016

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