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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05101044
• Other study ID #: 2104002974
• Secondary ID: R34DA053738
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2023
• Source: Brown University
• Contact: Ethan Moitra, PhD
• Phone: (401) 444-1949
• Email: ethan_moitra[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	National Institute on Drug Abuse (NIDA), The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant Retention Rate Across Intervention Sessions	The investigators will examine the percent of participants that complete all intervention sessions.	Baseline and 1 month
Secondary	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