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OpenTrials
Completed

NCT Number: NCT05101044

Open Trial to Improve Retention in Care for Persons With HIV Who Use Substances

The open trial will examine the feasibility and acceptability of a brief, empirically-supported acceptance-based behavioral therapy intervention to promote retention in care for out-of-care people with HIV who use substances.

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Key information

Conditions

Substance Use Disorders Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Social Behavior Social Stigma Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University, Providence, Rhode Island, United States

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About this study

The proposed study will adapt a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to help people with HIV (PWH) who use substances tolerate fears of stigmatization, increase acceptance of HIV status and substance use problems, and increase engagement in care. By conducting an open trial with 15 adults recruited from an HIV primary medical care clinic, the study will focus on the feasibility of recruiting out-of-care PWH and determine the acceptability of the refined ABBT protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV+
  • Meet DSM-5 criteria for one or more of the following substance use disorders, at any severity level: cocaine, methamphetamine, and/or opioid
  • ≥18 years old
  • Poorly retained in care, defined as no attended medical appointment in the past 9 months
  • Able to speak and read English at a level sufficient to complete the study procedures
  • Have telephone access

Exclusion criteria

(a) Patients who are cognitively impaired, which will be determined by chart review during screening

Treatment and study plan

Acceptance-based Behavioral Therapy (ABBT) Intervention

Behavioral

This acceptance-based behavioral therapy (ABBT) intervention intends to enhance retention in HIV care for people who use substances by targeting stigma. ABBT promotes an accepting stance towards life's challenges and encourages participants to thoughtfully disclose the serostatus and/or substance abuse problems as a behavioral step towards challenging stigmatization fears. The central hypothesis is that increased tolerance of stigmatization, facilitated through increased acceptance of HIV status and substance use behaviors, will increase PWH's longitudinal commitment to care.

Primary outcomes

  1. Client Satisfaction Questionnaire (CSQ)

    Time frame: 1 month

    The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.

Secondary outcomes

  1. Participant Retention Rate Across Intervention Sessions

    Time frame: Baseline and 1 month

    The investigators will examine the percent of participants that complete all intervention sessions.

  2. Participant Retention Rate for Follow Up Assessments

    Time frame: Baseline and 1 month

    The investigators will examine the percent of participants that complete the 1-month follow-up assessment.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • The Miriam Hospital

Registry information

Official study title

Improving Retention in Care for Persons With HIV Who Use Substances by Increasing Acceptance and Reducing Stigma (Open Trial)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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