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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04481373
Enrollment
75
Registered
2020-07-22
Start date
2021-03-03
Completion date
2024-02-29
Last updated
2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Human Immunodeficiency Virus

Keywords

Acceptance and Commitment Therapy, HIV, depression, anxiety, distress, avoidance

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.

Interventions

BEHAVIORALTHRIVE

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.

OTHERTreatment as Usual

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

Sponsors

University of Iowa
CollaboratorOTHER
Brown University
CollaboratorOTHER
University of Texas
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of Enrollment and Randomization: Eligible But Declined Participation6 monthsThe number of eligible PWH who agree and decline to participate, and reasons for declining;
Acceptability of Enrollment and Randomization: Completion Sessions6 monthsCompletion of at least 3 out of 4 intervention sessions in the THRIVE group
Acceptability of the Intervention: 6 Month Follow-up6 monthsThe completion of participant 6-month follow-up assessments
Acceptability of the Intervention6 monthsMean duration of contact for participants who completed all four sessions

Secondary

MeasureTime frameDescription
Viral Load Improvement6 monthsViral load less than 200 copies/mL at 180 days +/- 42 days of follow up
Number of Patients Who Are Retained in HIV Care6 monthsNumber of patients who complete at least 2 visits with an HIV clinician within 6 months, including 1 visit within 30 days of discharge

Other

MeasureTime frameDescription
Internalized AIDS-Related Stigma Scale (IARSS)6 monthsThe 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.
Client Satisfaction Questionnaire (CSQ)2 weeksThe 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.
Depression Anxiety and Stress Scale (DASS-21).6 monthsThe 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.
Alcohol Use Disorders Identification Test (AUDIT)6 monthsThis 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.
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)6 monthsThis 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.
Coping With HIV/AIDS Scale: Coping and Social Support6 monthsThe 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.
Coping With HIV/AIDS Scale6 monthsThere 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
THRIVE
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.
35
Treatment as Usual
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
35
Total70

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath before hospital discharge10
Overall StudyProtocol Violation10
Overall StudyViral load in hospital not over 100021

Baseline characteristics

CharacteristicTHRIVETotalTreatment as Usual
Age, Continuous47.2 Years
STANDARD_DEVIATION 12.3
44.7 Years
STANDARD_DEVIATION 12.1
42.1 Years
STANDARD_DEVIATION 11.8
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Alcoholic beverages
29 Participants56 Participants27 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Cannabis/Cocaine/Amphetamine/Inhalants/S
35 Participants68 Participants33 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Tobacco products
19 Participants42 Participants23 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Alcoholic beverages
7 Participants9 Participants2 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Cannabis/Cocaine/Amphetamine
7 Participants12 Participants5 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Tobacco products
14 Participants24 Participants10 Participants
AUDIT (Hazardous Alcohol Use)
Alcohol use (at least monthly)
20 Participants30 Participants10 Participants
AUDIT (Hazardous Alcohol Use)
Consumption at Hazardous level
7 Participants13 Participants6 Participants
Coping with HIV/AIDS Scale - Avoidance Coping2 units on a scale3 units on a scale3 units on a scale
Coping with HIV/AIDS Scale - Positive Coping2 units on a scale2 units on a scale3 units on a scale
Coping with HIV/AIDS Scale - Seeking Social Support Subscale
Seeking Social Support - Often or a lot for 1 of the 2 subscale items
10 Participants16 Participants6 Participants
Coping with HIV/AIDS Scale - Seeking Social Support Subscale
Seeking Social Support - Often or a lot for 2 of the 2 subscale items
1 Participants4 Participants3 Participants
Depression Anxiety and Stress Scale (DASS-21)
DASS-21 Anxiety
10 units on a scale10 units on a scale10 units on a scale
Depression Anxiety and Stress Scale (DASS-21)
DASS-21 Depression
8 units on a scale10 units on a scale10 units on a scale
Depression Anxiety and Stress Scale (DASS-21)
DASS-21 Stress
10 units on a scale10 units on a scale10 units on a scale
Depression Anxiety and Stress Scale (DASS-21)
DASS Total
26 units on a scale31 units on a scale36 units on a scale
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants18 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants52 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Internalized AIDS-Related Stigma Scale (IARSS)2 units on a scale3 units on a scale3 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
18 Participants38 Participants20 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants
Race (NIH/OMB)
White
15 Participants28 Participants13 Participants
Sex: Female, Male
Female
8 Participants15 Participants7 Participants
Sex: Female, Male
Male
27 Participants55 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 351 / 35
other
Total, other adverse events
0 / 350 / 35
serious
Total, serious adverse events
0 / 350 / 35

Outcome results

Primary

Acceptability of Enrollment and Randomization: Completion Sessions

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

Time frame: 6 months

Population: 80% of THRIVE participants received at least 3 of 4 sessions. Participants randomized to the Treatment as Usual arm were not analyzed and did not receive the intervention (sessions).

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
THRIVEAcceptability of Enrollment and Randomization: Completion Sessions28 Participants
Treatment as UsualAcceptability of Enrollment and Randomization: Completion Sessions0 Participants
Primary

Acceptability of Enrollment and Randomization: Eligible But Declined Participation

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
THRIVEAcceptability of Enrollment and Randomization: Eligible But Declined Participation0 Participants
Treatment as UsualAcceptability of Enrollment and Randomization: Eligible But Declined Participation0 Participants
Primary

Acceptability of the Intervention

Mean duration of contact for participants who completed all four sessions

Time frame: 6 months

Population: Treatment as usual participants did not get any intervention.

ArmMeasureValue (NUMBER)
THRIVEAcceptability of the Intervention135.5 minutes
Primary

Acceptability of the Intervention: 6 Month Follow-up

The completion of participant 6-month follow-up assessments

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
THRIVEAcceptability of the Intervention: 6 Month Follow-up21 Participants
Treatment as UsualAcceptability of the Intervention: 6 Month Follow-up26 Participants
Secondary

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
THRIVENumber of Patients Who Are Retained in HIV Care13 Participants
Treatment as UsualNumber of Patients Who Are Retained in HIV Care16 Participants
Secondary

Viral Load Improvement

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

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
THRIVEViral Load Improvement12 Participants
Treatment as UsualViral Load Improvement14 Participants
Other Pre-specified

Alcohol Use Disorders Identification Test (AUDIT)

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
THRIVEAlcohol Use Disorders Identification Test (AUDIT)Alcohol use (at least monthly)8 Participants
THRIVEAlcohol Use Disorders Identification Test (AUDIT)Consumption at Hazardous level6 Participants
Treatment as UsualAlcohol Use Disorders Identification Test (AUDIT)Alcohol use (at least monthly)13 Participants
Treatment as UsualAlcohol Use Disorders Identification Test (AUDIT)Consumption at Hazardous level9 Participants
Other Pre-specified

Client Satisfaction Questionnaire (CSQ)

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.

Time frame: 2 weeks

Population: CSQ was only measured in the THRIVE arm.

ArmMeasureValue (MEDIAN)
THRIVEClient Satisfaction Questionnaire (CSQ)31 units on a scale
Other Pre-specified

Coping With HIV/AIDS Scale

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.

Time frame: 6 months

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
THRIVECoping With HIV/AIDS ScaleSeeking Social Support - Often/a lot for 1 of 2 items4 Participants
THRIVECoping With HIV/AIDS ScaleSeeking Social Support - Often/a lot for 2 of 2 items2 Participants
Treatment as UsualCoping With HIV/AIDS ScaleSeeking Social Support - Often/a lot for 1 of 2 items4 Participants
Treatment as UsualCoping With HIV/AIDS ScaleSeeking Social Support - Often/a lot for 2 of 2 items2 Participants
Other Pre-specified

Coping With HIV/AIDS Scale: Coping and Social Support

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.

Time frame: 6 months

ArmMeasureGroupValue (MEDIAN)
THRIVECoping With HIV/AIDS Scale: Coping and Social SupportCoping with HIV - Positive Coping4 Medan, ICR
THRIVECoping With HIV/AIDS Scale: Coping and Social SupportCoping with HIV - Avoidance Coping3 Medan, ICR
Treatment as UsualCoping With HIV/AIDS Scale: Coping and Social SupportCoping with HIV - Positive Coping3.5 Medan, ICR
Treatment as UsualCoping With HIV/AIDS Scale: Coping and Social SupportCoping with HIV - Avoidance Coping3 Medan, ICR
Other Pre-specified

Depression Anxiety and Stress Scale (DASS-21).

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.

Time frame: 6 months

ArmMeasureGroupValue (MEDIAN)
THRIVEDepression Anxiety and Stress Scale (DASS-21).DASS-21 Total28 units on a scale
THRIVEDepression Anxiety and Stress Scale (DASS-21).DASS-21 Depression8 units on a scale
THRIVEDepression Anxiety and Stress Scale (DASS-21).DASS-21 Stress10 units on a scale
THRIVEDepression Anxiety and Stress Scale (DASS-21).DASS-21 Anxiety8 units on a scale
Treatment as UsualDepression Anxiety and Stress Scale (DASS-21).DASS-21 Anxiety11 units on a scale
Treatment as UsualDepression Anxiety and Stress Scale (DASS-21).DASS-21 Total32 units on a scale
Treatment as UsualDepression Anxiety and Stress Scale (DASS-21).DASS-21 Stress12 units on a scale
Treatment as UsualDepression Anxiety and Stress Scale (DASS-21).DASS-21 Depression10 units on a scale
Other Pre-specified

Internalized AIDS-Related Stigma Scale (IARSS)

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.

Time frame: 6 months

ArmMeasureValue (MEDIAN)
THRIVEInternalized AIDS-Related Stigma Scale (IARSS)2 units on a scale
Treatment as UsualInternalized AIDS-Related Stigma Scale (IARSS)3 units on a scale
Other Pre-specified

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

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
THRIVEThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Ever Used Tobacco products10 Participants
THRIVEThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Ever Used Alcoholic beverages12 Participants
THRIVEThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Ever Used Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives20 Participants
THRIVEThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Used in past 3 months Tobacco products7 Participants
THRIVEThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Used in past 3 months Alcoholic beverages4 Participants
THRIVEThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Used in past 3 months Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives7 Participants
Treatment as UsualThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Used in past 3 months Alcoholic beverages3 Participants
Treatment as UsualThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Ever Used Tobacco products13 Participants
Treatment as UsualThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Used in past 3 months Tobacco products11 Participants
Treatment as UsualThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Ever Used Alcoholic beverages20 Participants
Treatment as UsualThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Used in past 3 months Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives7 Participants
Treatment as UsualThe Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)Ever Used Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives26 Participants

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026