Contextualizing & Responding to HIV Risk Behaviors

NCT03300908 | Completed

• 2 other identifiers: AAAL7007K01DA036411
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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 (%).

  Over a 3-month period

Secondary Outcomes (1)

• Percentage of participants with HIV risk behaviors

  Over a 3-month period

Study Arms (2)

Project ADHERE

EXPERIMENTAL

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

Behavioral: Project ADHERE

Control MACE

ACTIVE COMPARATOR

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

Behavioral: MACE

Interventions

Project ADHERE 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.

Also known as: Project ADHerence Education and Risk Evaluation

Project ADHERE

MACE 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.

Also known as: Medication Adherence and Care Engagement

Control MACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• living in a healthcare or assisted living facility
• experienced incarceration longer than five years ago

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

omega-Chloroacetophenone

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Acetophenones; Ketones; Organic Chemicals

Study Officials

• Tawandra Rowell-Cunsolo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not aware of which intervention they were assigned to. A randomization scheme was developed and participants were assigned to treatment groups accordingly.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Social Welfare Science

Model Details: Participants were randomly assigned to Project ADHERE, or the control condition, MACE. The randomization process was described to participants during the informed consent process.

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 4, 2017
• Study Start: July 5, 2016
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-09

Locations

US (1)