Clinical trial NCT04481373: 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
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Depression
Anxiety
Keywords: Acceptance and Commitment Therapy
HIV
depression
anxiety
distress
avoidance
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: Brown University
name: University of Texas
First posted: 2020-07-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Acceptability of enrollment and randomization
timeFrame: 6 months
measure: Acceptability of enrollment and randomization
timeFrame: 6 months
measure: Acceptability of the intervention
timeFrame: 6 months
measure: Acceptability of the intervention
timeFrame: 6 months
measure: Acceptability of the intervention
timeFrame: 6 months
Secondary outcomes:
measure: Viral Load Improvement
timeFrame: 6 months
measure: Number of patients who are retained in HIV Care
timeFrame: 6 months
Other outcomes:
measure: Internalized AIDS-Related Stigma Scale (IARSS)
timeFrame: 6 months
measure: Depression Anxiety and Stress Scale (DASS-21).
timeFrame: 6 months
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 6 months
measure: The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: 6 months
measure: Coping with HIV/AIDS scale
timeFrame: 6 months
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 6 months
Locations:
city: Houston
country: United States
facility: Ben Taub Hospital
state: Texas
Study officials:
References:
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.