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Contextualizing & Responding to HIV Risk Behaviors

NCT ID: NCT03300908

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-05

Study Completion Date

2016-12-21

Brief Summary

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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

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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.

Conditions

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Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants were not aware of which intervention they were assigned to. A randomization scheme was developed and participants were assigned to treatment groups accordingly.

Study Groups

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Project ADHERE

Participants will receive a 3-session antiretroviral medication adherence and risk reduction intervention called Project ADHERE.

Group Type EXPERIMENTAL

Project ADHERE

Intervention Type BEHAVIORAL

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.

Control MACE

Participants will receive a one-session antiretroviral medication adherence intervention called MACE.

Group Type ACTIVE_COMPARATOR

MACE

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Project ADHerence Education and Risk Evaluation Medication Adherence and Care Engagement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Tawandra Rowell-Cunsolo

Assistant Professor of Social Welfare Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tawandra Rowell-Cunsolo, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Social Welfare Science (in Nursing), Nursing Scholarship & Research

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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K01DA036411

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAL7007

Identifier Type: -

Identifier Source: org_study_id