Contextualizing & Responding to HIV Risk Behaviors

September 29, 2017 updated by: Tawandra Rowell-Cunsolo, Columbia University

Contextualizing & Responding to HIV Risk Behaviors Among Black Drug Offenders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Project ADHERE
Participants will receive a 3-session antiretroviral medication adherence and risk reduction intervention called Project ADHERE.
Behavioral: Project ADHERE
This is a 3-session ART medication adherence and risk reduction intervention. Participants are educated about the importance of staying healthy and taking their medication as prescribed; to discuss importance of improved immune functioning and what their "viral load" means; reminded that they can still infect others with HIV, and that there currently is no cure for HIV; expected to generate strategies to overcome adherence barriers; educated about sexually transmitted infections (STI)/HIV transmission modes; assisted in devising an appropriate medication adherence and risk reduction plan. Participants will report their progress and discuss challenges experienced when implementing their medication adherence and risk reduction plans while establishing short- and long-term goals.
Other Names:
  • Project ADHerence Education and Risk Evaluation
Active Comparator: Control MACE
Participants will receive a one-session antiretroviral medication adherence intervention called MACE.
Behavioral: MACE
This one-session medication adherence intervention covers the following content: 1) a discussion on what viral load represents and what HIV does to the body; 2) referral to a provider for participants without a provider; 3) the importance of maintaining regular contact with a health care provider; and 4) benefits of being retained in care.
Other Names:
  • Medication Adherence and Care Engagement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who reached at least 85% medication adherence rate.
Time Frame: 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 (%).
Over a 3-month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants with HIV risk behaviors
Time Frame: 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.
Over a 3-month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Tawandra Rowell-Cunsolo, MD, Assistant Professor of Social Welfare Science (in Nursing), Nursing Scholarship & Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2016

Primary Completion (Actual)

December 21, 2016

Study Completion (Actual)

December 21, 2016

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

September 29, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAL7007
  • K01DA036411 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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