Adherence Intervention for HIV-infected Drug Users

NCT02907697 | Unknown

• 1 other identifier: K23DA039037
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Many people living with HIV use illicit drugs, which leads to worsened health outcomes and increased transmission of HIV due to poor adherence to medication regimens. This research will develop an intervention targeting medication adherence that is tailored to the unique needs of HIV-infected drug users. This research will promote adherence and improve treatment outcomes among HIV-infected drug users thereby minimizing the development of drug resistant strains of HIV and reducing transmission.

Conditions

HIV; Substance Use

Keywords

HIV/AIDS; adherence; substance use; HIV care continuum

Outcome Measures

Primary Outcomes (1)

• Antiretroviral Adherence

  Change in Antiretroviral Adherence will be assessed by use of medical event monitoring systems (MEMS). MEMS is a pill-bottle-cap with a pressure activated chip which records time/date the bottle is opened. MEMS data will be collected on one antiretroviral medication following a triage criterion established in studies of antiretroviral adherence.

  1-, 3-, and 6-months

Secondary Outcomes (8)

• Center for Epidemiologic Studies Depression Scale (CES-D)

  1-, 3-, and 6-months

• HIV Treatment Adherence Self-Efficacy (HIV-ASES)

  1-, 3-, and 6-months

• U.S. Health Resources and Service Administration measure of HIV treatment retention

  1-, 6-months

• Risk Assessment Battery

  1-, 3-, and 6-months

• HIV1 Ultra RT PCR-Roche test

  1-, 3-, and 6-months

Study Arms (2)

LifeSteps-Drug Use

EXPERIMENTAL

The investigators expect the LifeSteps-Drug Use adaptation will be modeled after the Life Steps adherence intervention with the addition of a Drug Use module based on motivational interviewing and the FRAMES approach. The LifeSteps-Drug Use intervention is expected to include two in-person sessions and two telephone booster sessions. While anticipated preliminary adaptations have been based on the extant literature, changes to the protocol will be based on data obtained during the qualitative phase which will be sufficiently broad and open to assess for factors that we have not anticipated.

Behavioral: Life Steps-Drug Use

Health Education

ACTIVE COMPARATOR

The health education condition is a time-matched, active control arm. It will consist of two in-person sessions and two telephone sessions. Each session will cover a general health education topic.

Behavioral: General Health Education

Interventions

Life Steps-Drug Use BEHAVIORAL

LifeSteps-Drug Use

General Health Education BEHAVIORAL

Health Education

Eligibility Criteria

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

You may qualify if:

• over 18 years of age
• HIV-infected
• prescribed an antiretroviral regimen
• meet DSM-V criteria for a substance use disorder (other than tobacco and alcohol) and report ≥3 days of use of an illicit drug per month over the past 90 days.
• self-report \<100% adherence and have experienced a detectable viral load (\>20 copies/mL) within the last 6 months.

You may not qualify if:

• cognitive impairments that jeopardize informed consent
• active psychosis
• current suicidal ideation
• not fluent in English
• have a prescription for and report only medicinal use of marijuana

Sponsors & Collaborators

• University of Texas at Austin: lead
• Brown University: collaborator

Study Sites (1)

Unviersity of Texas Dell Medical School

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Claborn K, Becker S, Operario D, Safren S, Rich JD, Ramsey S. Adherence intervention for HIV-infected persons who use drugs: adaptation, open trial, and pilot randomized hybrid type 1 trial protocol. Addict Sci Clin Pract. 2018 Apr 2;13(1):12. doi: 10.1186/s13722-018-0113-5.

  PMID: 29606129 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; 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

Study Officials

• Kasey Claborn, PhD

  The Unviersity of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 20, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2022
• Study Completion: December 30, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)