Clinical trial NCT03300908: Contextualizing & Responding to HIV Risk Behaviors
Official title: Contextualizing & Responding to HIV Risk Behaviors Among Black Drug Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-10-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to Project ADHERE, or the control condition, MACE. The randomization process was described to participants during the informed consent process.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of participants who reached at least 85% medication adherence rate.
timeFrame: Over a 3-month period
Secondary outcomes:
measure: Percentage of participants with HIV risk behaviors
timeFrame: Over a 3-month period
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Social Welfare Science (in Nursing), Nursing Scholarship & Research
name: Tawandra Rowell-Cunsolo, MD
role: PRINCIPAL_INVESTIGATOR
References: