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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05101044

Enrollment

Registered

2021-11-01

Start date

2022-04-01

Completion date

2024-05-31

Last updated

2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, Substance Use Disorders

Keywords

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

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.

Interventions

BEHAVIORALAcceptance-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026