search
Back to results

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

Primary Purpose

Substance Use Disorders, Hiv

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance-based Behavioral Therapy (ABBT) Intervention
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders focused on measuring Acceptance and commitment therapy, Acceptance-based behavioral therapy, Behavioral intervention, Acceptability and feasibility, Stigma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Miriam HospitalRecruiting
  • Brown UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acceptance-based Behavioral Therapy (ABBT) Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2021
Last Updated
February 8, 2023
Sponsor
Brown University
Collaborators
The Miriam Hospital, National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05101044
Brief Title
Open Trial to Improve Retention in Care for Persons With HIV Who Use Substances
Official Title
Improving Retention in Care for Persons With HIV Who Use Substances by Increasing Acceptance and Reducing Stigma (Open Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
The Miriam Hospital, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Hiv
Keywords
Acceptance and commitment therapy, Acceptance-based behavioral therapy, Behavioral intervention, Acceptability and feasibility, Stigma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An uncontrolled open trial approach will be used in which all participants receive the ABBT intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance-based Behavioral Therapy (ABBT) Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-based Behavioral Therapy (ABBT) Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Participant Retention Rate Across Intervention Sessions
Description
The investigators will examine the percent of participants that complete all intervention sessions.
Time Frame
Baseline and 1 month
Title
Participant Retention Rate for Follow Up Assessments
Description
The investigators will examine the percent of participants that complete the 1-month follow-up assessment.
Time Frame
Baseline and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ethan Moitra, PhD
Phone
(401) 444-1949
Email
ethan_moitra@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Pinkston-Camp, PhD
Phone
(401) 793-3582
Email
mpinkston@lifespan.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ethan Moitra, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Pinkston-Camp, PhD
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Moitra
Phone
401-444-1949
Email
ethan_moitra@brown.edu
First Name & Middle Initial & Last Name & Degree
Ethan Moitra, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs