Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Primary Purpose
HIV/AIDS
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance-Based Behavior Therapy (ABBT)
Enhanced-Treatment-as-Usual (ETAU)
Sponsored by
About this trial
This is an interventional treatment trial for HIV/AIDS focused on measuring Medication adherence, Treatment adherence, HIV, Acceptance and Commitment Therapy, Retention
Eligibility Criteria
Inclusion Criteria:
- HIV+
- ≥18 years old
- Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
- Able to speak and read English at the level to be able to complete the study procedures
- Have telephone access.
Exclusion Criteria:
1. Cognitively impaired
Sites / Locations
- Brown UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acceptance-Based Behavior Therapy (ABBT)
Enhanced-Treatment-as-Usual (ETAU)
Arm Description
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Outcomes
Primary Outcome Measures
Retention in medical care
Objective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period.
Virologic suppression
Objective data from participants' electronic health records will be obtained to examine their viral load, which is a blood-based measure of the amount of HIV viruses in the person's body. If participants are not currently retained in medical care and blood sample results are not available in their electronic health record, they will submit 1-3ml of blood at each assessment through the study's research phlebotomist.
Secondary Outcome Measures
Self-Rating Scale Item (SRSI) - Antiretroviral Treatment adherence
Self-report data of participants' HIV antiretroviral treatment adherence will be obtained with the SRSI. Scores range from 0 to 5, which correspond to "very poor" to "excellent" medication adherence.
Brief HIV Disclosure and Safer Sex Self-Efficacy Scales (BHD)
The BHD HIV disclosure subscale will be used to assess for willingness to make informed disclosure and for actual disclosure of HIV status. Scores range from 8-32, with higher scores indicating increased willingness to disclose.
The Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support.
HIV Stigma Scale (HSS)
The HSS will be used to measure self-reported experiences, fear, and perception of stigmatization due to being HIV+. Scores range from 6-24, with lower scores indicating less fear or concern about stigmatization.
Full Information
NCT ID
NCT04201288
First Posted
December 12, 2019
Last Updated
February 8, 2023
Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04201288
Brief Title
Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Official Title
Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 21, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.
The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.
Detailed Description
Drop-out rates from medical clinics in the first months following linkage to HIV care are as high as 50%, with 31-46% of patients dropping out after the first visit. People Living with HIV (PLWH) who are not consistently retained in care are at risk for: delayed antiretroviral treatment (ART) initiation, reduced ART adherence, unsuppressed viremia, and mortality. Moreover, poor retention means effective ART cannot be leveraged to prevent further HIV transmission. The objective of this study is to conduct a fully powered, randomized controlled trial (RCT) to assess the efficacy of a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to enhance retention in HIV care.
The aims of this proposal are: (1) To test, in a 2-arm RCT, the efficacy of the ABBT intervention on retention in care and virologic suppression (primary outcomes); and, ART adherence, disclosure of HIV status, perceived social support, HIV stigmatization (secondary outcomes), relative to an Enhanced-Treatment-as-Usual condition; and, (2) To examine the degree to which retention in HIV care and virologic suppression are mediated by (a) increased HIV acceptance (and decreased HIV experiential avoidance) and (b) increased willingness to disclose HIV status. The sample will consist of 270 HIV patients who are new to care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Medication adherence, Treatment adherence, HIV, Acceptance and Commitment Therapy, Retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acceptance-Based Behavior Therapy (ABBT)
Arm Type
Experimental
Arm Description
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Arm Title
Enhanced-Treatment-as-Usual (ETAU)
Arm Type
Placebo Comparator
Arm Description
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance-Based Behavior Therapy (ABBT)
Intervention Description
Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced-Treatment-as-Usual (ETAU)
Intervention Description
ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
Primary Outcome Measure Information:
Title
Retention in medical care
Description
Objective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period.
Time Frame
52 weeks
Title
Virologic suppression
Description
Objective data from participants' electronic health records will be obtained to examine their viral load, which is a blood-based measure of the amount of HIV viruses in the person's body. If participants are not currently retained in medical care and blood sample results are not available in their electronic health record, they will submit 1-3ml of blood at each assessment through the study's research phlebotomist.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Self-Rating Scale Item (SRSI) - Antiretroviral Treatment adherence
Description
Self-report data of participants' HIV antiretroviral treatment adherence will be obtained with the SRSI. Scores range from 0 to 5, which correspond to "very poor" to "excellent" medication adherence.
Time Frame
52 weeks
Title
Brief HIV Disclosure and Safer Sex Self-Efficacy Scales (BHD)
Description
The BHD HIV disclosure subscale will be used to assess for willingness to make informed disclosure and for actual disclosure of HIV status. Scores range from 8-32, with higher scores indicating increased willingness to disclose.
Time Frame
52 weeks
Title
The Multidimensional Scale of Perceived Social Support (MSPSS)
Description
The MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support.
Time Frame
52 weeks
Title
HIV Stigma Scale (HSS)
Description
The HSS will be used to measure self-reported experiences, fear, and perception of stigmatization due to being HIV+. Scores range from 6-24, with lower scores indicating less fear or concern about stigmatization.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV+
≥18 years old
Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
Able to speak and read English at the level to be able to complete the study procedures
Have telephone access.
Exclusion Criteria:
1. Cognitively impaired
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debra Herman, Ph.D.
Phone
401-455-6652
Email
DHerman@Butler.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ethan Moitra, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
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
Yes
IPD Sharing Plan Description
The investigators will share data via the Research Data Center at the CDC's National Center for Health Statistics (NCHS).
IPD Sharing Time Frame
Data will be shared upon the completion of the study and after summary data are published in a peer-reviewed journal. Consistent with NIMH guidelines, there will be no specific time limit regarding how long IPD are available.
IPD Sharing Access Criteria
Request to access the data will be evaluated by the PI to ensure that they meet reasonable standards of scientific integrity.
Learn more about this trial
Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
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