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

Not Applicable

Completed

• Conditions: Substance Use Disorders; Hiv
• Interventions: Behavioral: Acceptance-based Behavioral Therapy (ABBT) Intervention

• Registration Number: NCT05101044
• Lead Sponsor: Brown University

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.

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 Timeline

• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-11-01
• Study Start: 2022-04-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acceptance-based Behavioral Therapy (ABBT) Intervention	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.

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ)	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 Outcome Measures

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

Trial Locations

Locations (2)

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States