Skip to main content
OpenTrials
Completed

NCT Number: NCT04481373

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thrive

Behavioral

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.

Other names: Acceptance and Commitment Therapy plus Education

Treatment as Usual

Other

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

Primary outcomes

  1. Acceptability of Enrollment and Randomization: Eligible But Declined Participation

    Time frame: 6 months

    The number of eligible PWH who agree and decline to participate, and reasons for declining;

  2. Acceptability of Enrollment and Randomization: Completion Sessions

    Time frame: 6 months

    Completion of at least 3 out of 4 intervention sessions in the THRIVE group

  3. Acceptability of the Intervention: 6 Month Follow-up

    Time frame: 6 months

    The completion of participant 6-month follow-up assessments

  4. Acceptability of the Intervention

    Time frame: 6 months

    Mean duration of contact for participants who completed all four sessions

Secondary outcomes

  1. Viral Load Improvement

    Time frame: 6 months

    Viral load less than 200 copies/mL at 180 days +/- 42 days of follow up

  2. Number of Patients Who Are Retained in HIV Care

    Time frame: 6 months

    Number of patients who complete at least 2 visits with an HIV clinician within 6 months, including 1 visit within 30 days of discharge

Other outcomes

  1. Internalized AIDS-Related Stigma Scale (IARSS)

    Time frame: 6 months

    The Internalized AIDS-Related Stigma Scale (IARSS) is a 6-item scale with scores that range between 0 and 6. There are 6 questions in the stigma scale. Each question answered "yes" counts as one point. A higher total sum suggests more internalized stigma, which is not beneficial.

  2. Depression Anxiety and Stress Scale (DASS-21).

    Time frame: 6 months

    The Depression Anxiety and Stress Scale (DASS-21) has 21 items. Each item is scored 1, 2, or 3. The score is calculated by adding each item's score, multiplied by 2. The range of scores for the total scale is between 0 and 126. Each subscale (depression, anxiety, and stress) has 7 items with a range of scores between 0 and 42. Higher scores suggest higher depression, anxiety, and stress, which are not beneficial.

  3. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: 6 months

    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.

  4. The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)

    Time frame: 6 months

    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.

  5. Coping With HIV/AIDS Scale: Coping and Social Support

    Time frame: 6 months

    The coping with HIV/AIDS positive coping scale scores range between 0 and 5. There are 5 questions in the positive coping subscale. Each question answered "often or a lot of the time" counts as one point. A higher total sum suggests more positive coping, which is beneficial.

    The coping with HIV/AIDS avoidance coping scale scores range between 0 and 9. There are 9 questions in the avoidance coping subscale. Each question answered "often or a lot of the time" counts as one point. A higher total sum suggests more avoidance coping, which is not beneficial.

  6. Coping With HIV/AIDS Scale

    Time frame: 6 months

    There are 2 questions in the seeking social support subscale. We report the number of participants who answer each question "often or a lot of the time". More responses "often or a lot of the time" suggests seeking more social support, which is beneficial.

  7. Client Satisfaction Questionnaire (CSQ)

    Time frame: 2 weeks

    The Client Satisfaction Questionnaire (CSQ) scale has 8 items. Each item is scored 1, 2, 3, or 4. The score is calculated by adding each item's score. The range of scores for the total scale is between 8 and 32. Higher scores represent greater satisfaction with the THRIVE intervention.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Brown University
  • National Institute of Mental Health (NIMH)
  • University of Iowa
  • University of Texas

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2020
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.