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

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

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.

Study Overview

• Status: Completed
• Conditions: Hiv; Substance Use Disorders
• Intervention / Treatment: Behavioral: Acceptance-based Behavioral Therapy (ABBT) Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. HIV+
2. Meet DSM-5 criteria for one or more of the following substance use disorders, at any severity level: cocaine, methamphetamine, and/or opioid
3. ≥18 years old
4. Poorly retained in care, defined as no attended medical appointment in the past 9 months
5. Able to speak and read English at a level sufficient to complete the study procedures
6. Have telephone access

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Acceptance-based Behavioral Therapy (ABBT) Intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Retention Rate Across Intervention Sessions	The investigators will examine the percent of participants that complete all intervention sessions.	Baseline and 1 month
Participant Retention Rate for Follow Up Assessments	The investigators will examine the percent of participants that complete the 1-month follow-up assessment.	Baseline and 1 month

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Institute on Drug Abuse (NIDA); The Miriam Hospital
• Investigators: Principal Investigator: Ethan Moitra, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Stigma; Behavioral intervention; Acceptance and commitment therapy; Acceptance-based behavioral therapy; Acceptability and feasibility
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2104002974; R34DA053738 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No