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

NCT ID: NCT05101044

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-05-31

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.

Conditions

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Substance Use Disorders Hiv

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Acceptance-based Behavioral Therapy (ABBT) Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ethan Moitra, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R34DA053738

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2104002974

Identifier Type: -

Identifier Source: org_study_id

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