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Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')

Primary Purpose

Human Immunodeficiency Virus, Depression, Anxiety

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
THRIVE
Treatment as Usual
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring Acceptance and Commitment Therapy, HIV, depression, anxiety, distress, avoidance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized at Ben Taub Hospital, Houston, TX;
  • at least 18 years of age;
  • able to speak English or Spanish;
  • HIV infected;
  • able to provide informed consent and participate in the study (patients who are temporarily unable to participate will be followed and approached for enrollment if and when they are cognitively and physically capable of consenting and participating);
  • HIV VL>1000 c/mL;
  • never in care or currently out of HIV care, defined as not meeting the 'visit constancy' measure (≥1 completed HIV primary care visit at Thomas Street Health Center (TSHC), Houston, TX, in each of the three 4-month intervals preceding admission); or ≥2 "no shows" to HIV primary care visits at TSHC in the last year.
  • endorse one of two avoidance coping statements with the highest factor loadings on the Avoidant Coping Subscale from the Coping with HIV/AIDS scale

Exclusion Criteria:

  • intending to use a source of HIV primary care other than TSHC after discharge, because their outcomes cannot be evaluated;
  • in the opinion of the primary medical team caring for the patient, likely to be discharged to an institutional setting, die in the hospital or enter hospice;
  • incarcerated or expected to be discharged to prison or jail;
  • enrolled in another research study with prospective follow-up;
  • pregnant, since pregnant women receive additional efforts to be linked and retained in care;
  • admitted with acute psychosis which would preclude informed consent or meaningful participation with the intervention.

Sites / Locations

  • Ben Taub Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

THRIVE

Treatment as Usual

Arm Description

Acceptance and Commitment Therapy plus Education about HIV A master's level mental health professional will provide the 4-5 hour intervention for out-of-care PWH during a hospitalization. There are two important components to the intervention: Acceptance and Commitment Therapy (ACT) content, targeting avoidance with acceptance-based coping and active engagement in values-based living, and HIV education.

Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.

Outcomes

Primary Outcome Measures

Acceptability of enrollment and randomization
The number of eligible PWH who agree and decline to participate, and reasons for declining;
Acceptability of enrollment and randomization
The number of PWH who are not eligible to participate and the reasons for lack of eligibility.
Acceptability of the intervention
Intervention completion rate
Acceptability of the intervention
Retention of participants in follow-up assessments
Acceptability of the intervention
Duration of contacts

Secondary Outcome Measures

Viral Load Improvement
Change in Viral Load
Number of patients who are retained in HIV Care
Number of patients who complete at least 2 visits with an HIV clinician within 6 months

Full Information

First Posted
July 9, 2020
Last Updated
July 17, 2023
Sponsor
Baylor College of Medicine
Collaborators
University of Iowa, Brown University, University of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT04481373
Brief Title
Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')
Official Title
Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
University of Iowa, Brown University, University of Texas

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
Many people with HIV infection are not consistently engaged in outpatient HIV care, and avoidance, stigma and denial contribute to poor engagement in HIV care. This project will develop and pilot test a new intervention, "THRIVE," for hospitalized persons who are out of HIV care and endorse avoidance, to improve how well they stay in outpatient HIV care after discharge. If successfully developed, the intervention will undergo large scale testing in later studies and could improve the health of persons with HIV infection and help end the HIV epidemic in the United States.
Detailed Description
Poor retention in HIV primary care results in lower rates of HIV viral suppression, higher rates of HIV transmission, and exacerbates racial and ethnic disparities in health outcomes, including survival. To date, there are no interventions that effectively relink and retain PWH in care when they are found outside the HIV clinic. Many persons with HIV infection (PWH) are hospitalized with life-threatening but preventable complications of inadequately treated HIV infection. They are among the most important patients to retain in care. Our previous research shows that among PWH who are out of care and hospitalized, avoidance coping, stigma, and mental health difficulties were nearly universal. Further, avoidance coping was a predictor of failure to re-engage in care after discharge. Acceptance and Commitment Therapy (ACT) is a transdiagnostic intervention with the capacity to address a range of psychosocial and behavior-related issues that PWH experience. ACT helps patients overcome avoidance, particularly avoidance of uncomfortable internal states and the situations that trigger such states, by promoting acceptance-based coping and re-engagement in meaningful and valued-life activities. Brief ACT interventions appear to be feasible, acceptable, and at least preliminarily, have efficacy. The investigators propose to develop, refine, and pilot a brief (4-5 contact hours) ACT intervention for hospitalized, out-of-care PWH. 'Targeting HIV Retention and Improved Viral load through Engagement' ('THRIVE') will aim to help patients overcome avoidance, a maladaptive coping strategy implicated in a range of problems, including depression, anxiety, substance abuse, and HIV-related self-stigma, all of which constitute barriers to care. Delivering THRIVE in the hospital with a phone booster session after discharge will increase therapy initiation and completion, the lack of which is often the greatest obstacle to effective delivery of mental health services for PWH. In Aim 1, a brief hospital-based transdiagnostic, individually delivered ACT intervention (THRIVE) tailored specifically for out-of-care hospitalized PWH will be developed. Input from a multi-disciplinary team of expert care providers and PHW will be utilized to create the therapist protocol and patient workbook. The investigators will then pilot THRIVE in 10 hospitalized out-of-care PWH who will provide qualitative feedback on the intervention. The feedback, along with input from patients and the multi-disciplinary team, will be used to refine THRIVE. In Aim 2, the investigators will conduct a pilot randomized clinical trial (RCT) of the refined THRIVE intervention (N=35) compared to treatment as usual (N=35). This pilot RCT will 1) evaluate feasibility and acceptability for a full-scale RCT; and 2) examine trends in outcomes of interest for the definitive RCT. The investigators will then be positioned to submit a separate grant to test the efficacy of THRIVE in a fully powered randomized trial. This work has the potential to decrease HIV morbidity and racial/ethnic disparities and contribute to ending the HIV epidemic in the United States, which are NIH priorities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Depression, Anxiety
Keywords
Acceptance and Commitment Therapy, HIV, depression, anxiety, distress, avoidance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THRIVE
Arm Type
Experimental
Arm Description
Acceptance and Commitment Therapy plus Education about HIV A master's level mental health professional will provide the 4-5 hour intervention for out-of-care PWH during a hospitalization. There are two important components to the intervention: Acceptance and Commitment Therapy (ACT) content, targeting avoidance with acceptance-based coping and active engagement in values-based living, and HIV education.
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Intervention Type
Behavioral
Intervention Name(s)
THRIVE
Other Intervention Name(s)
Acceptance and Commitment Therapy plus Education
Intervention Description
The ACT components (3-3.5 hours) will focus on clarifying patient values and goals and identifying obstacles that may be getting in the way of living a rich life. Short-and long-term effects of avoidance will be discussed (e.g., avoidance reduces immediate contact with distressing experiences and provides short-term relief but leads to greater dysfunction in long run). Patients will be taught acceptance, mindfulness, and perspective taking to help patient cope with difficult emotions and thoughts that may interfere with living a values-driven life. Individuals will also be encouraged to examine the costs of stigmatization on their life (e.g. avoidance of medical care, sense of isolation). Education will include medical information about HIV, services available at the clinic, and health needs related to comorbidities. This content to be delivered in 30 minutes.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Primary Outcome Measure Information:
Title
Acceptability of enrollment and randomization
Description
The number of eligible PWH who agree and decline to participate, and reasons for declining;
Time Frame
6 months
Title
Acceptability of enrollment and randomization
Description
The number of PWH who are not eligible to participate and the reasons for lack of eligibility.
Time Frame
6 months
Title
Acceptability of the intervention
Description
Intervention completion rate
Time Frame
6 months
Title
Acceptability of the intervention
Description
Retention of participants in follow-up assessments
Time Frame
6 months
Title
Acceptability of the intervention
Description
Duration of contacts
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Viral Load Improvement
Description
Change in Viral Load
Time Frame
6 months
Title
Number of patients who are retained in HIV Care
Description
Number of patients who complete at least 2 visits with an HIV clinician within 6 months
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Internalized AIDS-Related Stigma Scale (IARSS)
Description
This is a 6-item measure examines internalized stigma. Response scores range from 0 (low stigma)-6 (high stigma) with higher scores representing higher levels of stigma.
Time Frame
6 months
Title
Depression Anxiety and Stress Scale (DASS-21).
Description
This is a 21-item measure. The total score ranges from 0-120 with higher scores reflecting higher levels of distress including depression, anxiety, and stress.
Time Frame
6 months
Title
Alcohol Use Disorders Identification Test (AUDIT)
Description
This 3-item screener that identifies problem alcohol use for both men and women. Participants respond on a 5-point scale. Higher numbers represent more difficulty.
Time Frame
6 months
Title
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Description
This measure asks about substance use of 7 categories of drugs in the previous 3 months and in a person's life time. Participants respond YES or NO to each category of drugs.
Time Frame
6 months
Title
Coping with HIV/AIDS scale
Description
This is a 16 item measure that examines positive coping, avoidant coping, and social support. Items are scores from 1-3 with higher scores reflecting greater positive coping, greater avoidant coping, and greater social support.
Time Frame
6 months
Title
Client Satisfaction Questionnaire (CSQ)
Description
This 8-item measure assesses patient satisfaction with services. Scores range from 8-32 with higher scores representing greater satisfaction.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized at Ben Taub Hospital, Houston, TX; at least 18 years of age; able to speak English or Spanish; HIV infected; able to provide informed consent and participate in the study (patients who are temporarily unable to participate will be followed and approached for enrollment if and when they are cognitively and physically capable of consenting and participating); HIV VL>1000 c/mL; never in care or currently out of HIV care, defined as not meeting the 'visit constancy' measure (≥1 completed HIV primary care visit at Thomas Street Health Center (TSHC), Houston, TX, in each of the three 4-month intervals preceding admission); or ≥2 "no shows" to HIV primary care visits at TSHC in the last year. endorse one of two avoidance coping statements with the highest factor loadings on the Avoidant Coping Subscale from the Coping with HIV/AIDS scale Exclusion Criteria: intending to use a source of HIV primary care other than TSHC after discharge, because their outcomes cannot be evaluated; in the opinion of the primary medical team caring for the patient, likely to be discharged to an institutional setting, die in the hospital or enter hospice; incarcerated or expected to be discharged to prison or jail; enrolled in another research study with prospective follow-up; pregnant, since pregnant women receive additional efforts to be linked and retained in care; admitted with acute psychosis which would preclude informed consent or meaningful participation with the intervention.
Facility Information:
Facility Name
Ben Taub Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35628955
Citation
Dindo L, Moitra E, Roddy MK, Ratcliff C, Markham C, Giordano T. Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial. J Clin Med. 2022 May 17;11(10):2827. doi: 10.3390/jcm11102827.
Results Reference
derived

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Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')

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