Contextualizing & Responding to HIV Risk Behaviors
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project ADHERE
MACE
Sponsored by
About this trial
This is an interventional supportive care trial for Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
- ≥18 years of age
- HIV seropositive with "detectable" viral load (VL)(defined as >50 copies/mL)
- history of drug use (used illicit drugs within the past year)
- experienced incarceration in prison or jail within the past five years
Exclusion Criteria:
- living in a healthcare or assisted living facility
- experienced incarceration longer than five years ago
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Project ADHERE
Control MACE
Arm Description
Participants will receive a 3-session antiretroviral medication adherence and risk reduction intervention called Project ADHERE.
Participants will receive a one-session antiretroviral medication adherence intervention called MACE.
Outcomes
Primary Outcome Measures
Number of participants who reached at least 85% medication adherence rate.
Self-report data and viral loads to test for medication adherence will be collected and analyzed to yield the rate (%).
Secondary Outcome Measures
Percentage of participants with HIV risk behaviors
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.
Full Information
NCT ID
NCT03300908
First Posted
September 29, 2017
Last Updated
September 29, 2017
Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03300908
Brief Title
Contextualizing & Responding to HIV Risk Behaviors
Official Title
Contextualizing & Responding to HIV Risk Behaviors Among Black Drug Offenders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 5, 2016 (Actual)
Primary Completion Date
December 21, 2016 (Actual)
Study Completion Date
December 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Participants were not aware of which intervention they were assigned to. A randomization scheme was developed and participants were assigned to treatment groups accordingly.
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Project ADHERE
Arm Type
Experimental
Arm Description
Participants will receive a 3-session antiretroviral medication adherence and risk reduction intervention called Project ADHERE.
Arm Title
Control MACE
Arm Type
Active Comparator
Arm Description
Participants will receive a one-session antiretroviral medication adherence intervention called MACE.
Intervention Type
Behavioral
Intervention Name(s)
Project ADHERE
Other Intervention Name(s)
Project ADHerence Education and Risk Evaluation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MACE
Other Intervention Name(s)
Medication Adherence and Care Engagement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who reached at least 85% medication adherence rate.
Description
Self-report data and viral loads to test for medication adherence will be collected and analyzed to yield the rate (%).
Time Frame
Over a 3-month period
Secondary Outcome Measure Information:
Title
Percentage of participants with HIV risk behaviors
Description
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.
Time Frame
Over a 3-month period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥18 years of age
HIV seropositive with "detectable" viral load (VL)(defined as >50 copies/mL)
history of drug use (used illicit drugs within the past year)
experienced incarceration in prison or jail within the past five years
Exclusion Criteria:
living in a healthcare or assisted living facility
experienced incarceration longer than five years ago
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tawandra Rowell-Cunsolo, MD
Organizational Affiliation
Assistant Professor of Social Welfare Science (in Nursing), Nursing Scholarship & Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Contextualizing & Responding to HIV Risk Behaviors
We'll reach out to this number within 24 hrs