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

NCT05101044 | Completed

• 2 other identifiers: 2104002974R34DA053738
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Substance Use Disorders; Hiv

Keywords

Acceptance and commitment therapy; Acceptance-based behavioral therapy; Behavioral intervention; Acceptability and feasibility; Stigma

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Questionnaire (CSQ)

  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.

  1 month

Secondary Outcomes (2)

• Participant Retention Rate Across Intervention Sessions

  Baseline and 1 month

• Participant Retention Rate for Follow Up Assessments

  Baseline and 1 month

Study Arms (1)

Acceptance-based Behavioral Therapy (ABBT) Intervention

EXPERIMENTAL

All recruited individuals will receive ABBT intervention. ABBT involves 2 sessions delivered within about a week of each other, consisting of a 20-25 minute session 1, and a 10 minute session 2.

Behavioral: Acceptance-based Behavioral Therapy (ABBT) Intervention

Interventions

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.

Acceptance-based Behavioral Therapy (ABBT) Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Brown University: lead
• The Miriam Hospital: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome; Social Stigma

Interventions

Methods

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; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ethan Moitra, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An uncontrolled open trial approach will be used in which all participants receive the ABBT intervention.

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: April 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)