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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hiv, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Acceptance-based Behavioral Therapy (ABBT) Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: An uncontrolled open trial approach will be used in which all participants receive the ABBT intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acceptance-based Behavioral Therapy (ABBT) Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acceptance and commitment therapy, Acceptance-based behavioral therapy, Behavioral intervention, Acceptability and feasibility, Stigma