Human Immunodeficiency VirusNCT04481373
Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')
A study testing THRIVE and Treatment as Usual in people with Human Immunodeficiency Virus and Depression, run by Baylor College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Human Immunodeficiency Virus, Depression, Anxiety
- What is being tested?
- THRIVE and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2021to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus, Depression, Anxiety
- Being tested
- THRIVE, Treatment as Usual
- Keywords
- Acceptance and Commitment Therapy, HIV, depression, anxiety, distress, avoidance
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THRIVEBehavioural
Also called Acceptance and Commitment Therapy plus Education
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.
Treatment as UsualOther
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE | Experimental | 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. Receives: Behavioral: THRIVE |
| 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Enrollment and Randomization: Eligible But Declined Participation
The number of eligible PWH who agree and decline to participate, and reasons for declining;
Measured: 6 months
Acceptability of Enrollment and Randomization: Completion Sessions
Completion of at least 3 out of 4 intervention sessions in the THRIVE group
Measured: 6 months
Acceptability of the Intervention: 6 Month Follow-up
The completion of participant 6-month follow-up assessments
Measured: 6 months
Acceptability of the Intervention
Mean duration of contact for participants who completed all four sessions
Measured: 6 months
Secondary outcomes (2)
Viral Load Improvement
Viral load less than 200 copies/mL at 180 days +/- 42 days of follow up
Measured: 6 months
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, including 1 visit within 30 days of discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start3 Mar 2021
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iowa, Brown University, University of Texas, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Thomas Giordano, Baylor College of Medicine
- Investigators
- Lilian Dindo, Ph.D, Principal investigator, Baylor College of MedicineThomas Giordano, M.D., M.P.H., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481373
- Sponsor's protocol ID
- H-47444
- Other IDs
- 5R34MH122294
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2020
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35628955
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')
- ClinicalTrials.gov ID
- NCT04481373
- Acronym / sponsor ID
- H-47444
- Conditions
- Human Immunodeficiency Virus, Depression, Anxiety
- Keywords
- Acceptance and Commitment Therapy, HIV, depression, anxiety, distress, avoidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Iowa, Brown University, University of Texas, National Institute of Mental Health (NIMH)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| THRIVE | Experimental | Behavioral: THRIVEAcceptance 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. |
| Treatment as Usual | Other | Other: Treatment as UsualPatients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THRIVEAlso: Acceptance and Commitment Therapy plus EducationThe 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. | Behavioural | THRIVE |
| Treatment as UsualPatients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care. | Other | Treatment as Usual |
Primary outcome
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;
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
Acceptability of the Intervention: 6 Month Follow-up
Time frame: 6 months
The completion of participant 6-month follow-up assessments
Acceptability of the Intervention
Time frame: 6 months
Mean duration of contact for participants who completed all four sessions
2 secondary outcomes
Viral Load Improvement
Time frame: 6 months
Number of Patients Who Are Retained in HIV Care
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35628955Dindo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lilian Dindo, Ph.D principal investigator
Baylor College of Medicine
Thomas Giordano, M.D., M.P.H. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THRIVE and Treatment as Usual in people with Human Immunodeficiency Virus and Depression, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Enrollment and Randomization: Eligible But Declined Participation (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04481373, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.