Contextualizing & Responding to HIV Risk Behaviors

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus
• Interventions: Behavioral: Project ADHERE; Behavioral: MACE

• Registration Number: NCT03300908
• Lead Sponsor: Columbia University

Brief Summary

The purpose of this study was to pilot test the potential for improvement in antiretroviral medication adherence of a an adapted group-based, multi-session, community-based Antiretroviral Therapy (ART) adherence and risk reduction intervention, Project ADHerence Education and Risk Evaluation (ADHERE). Project ADHERE was compared to a single-session group-based medication adherence intervention, Medication Adherence and Care Engagement (MACE).

A secondary aim was to examine the impact of Project ADHERE on HIV risk behaviors (i.e., illicit drug use and unprotected sexual behavior).

This study was designed to inform, design, and pilot test the two antiretroviral medication adherence interventions for HIV-infected formerly incarcerated individuals.

Detailed Description

Formerly incarcerated Black drug offenders are at an elevated risk for HIV infection. Despite substantial research expressing the need for HIV prevention services for ex-offenders postrelease, this population has limited access to quality programming and services related to HIV risk reduction. This K01 application seeks to inform and adapt an HIV risk reduction intervention to address the needs of formerly incarcerated Black drug offenders who are being released from prisons in the New York City metropolitan area.The study will utilize qualitative and quantitative methods to inform and adapt an HIV prevention intervention for this study population.

Study Timeline

• Study Start: 2016-07-05
• Primary Completion: 2016-12-21
• Study Completion: 2016-12-21
• Status Verified: 2017-09
• Study First Submitted: 2017-09-29
• Study First Submitted QC: 2017-09-29
• Last Update Submitted: 2017-09-29
• Study First Posted: 2017-10-04
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. ≥18 years of age
2. HIV seropositive with "detectable" viral load (VL)(defined as >50 copies/mL)
3. history of drug use (used illicit drugs within the past year)
4. experienced incarceration in prison or jail within the past five years

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Exclusion Criteria

1. living in a healthcare or assisted living facility
2. experienced incarceration longer than five years ago

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Project ADHERE	Project ADHERE	Participants will receive a 3-session antiretroviral medication adherence and risk reduction intervention called Project ADHERE.
Control MACE	MACE	Participants will receive a one-session antiretroviral medication adherence intervention called MACE.

Primary Outcome Measures

Name	Time	Method
Number of participants who reached at least 85% medication adherence rate.	Over a 3-month period	Self-report data and viral loads to test for medication adherence will be collected and analyzed to yield the rate (%).

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with HIV risk behaviors	Over a 3-month period	Information on illicit drug use and unprotected sexual behavior wil be collected and analyzed. We sought to reduce the frequency of illicit drug use, and instance of unprotected sexual behavior as calculated in the percentage of participants.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States