NCT04481373

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

Completed NA Results posted Last updated 14 October 2025

What this trial tests

NA trial testing THRIVE in Human Immunodeficiency Virus in 75 participants. Completed in 29 February 2024.

Timeline

3 March 2021

Primary endpoint
29 February 2024

29 February 2024

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	75
Start date	3 March 2021
Primary completion	29 February 2024
Estimated completion	29 February 2024
Sites	1 location across United States

Drugs / interventions tested

• THRIVE
• Treatment as Usual

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →

Sponsor

Baylor College of Medicine

Who can join

Adults 18 to 80, any sex, with Human Immunodeficiency Virus or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability of Enrollment and Randomization: Eligible But Declined Participation Primary · 6 months

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

Group	Value	95% CI
THRIVE	0
Treatment as Usual	0

Acceptability of Enrollment and Randomization: Completion Sessions Primary · 6 months

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

Group	Value	95% CI
THRIVE	28
Treatment as Usual	0

Acceptability of the Intervention: 6 Month Follow-up Primary · 6 months

The completion of participant 6-month follow-up assessments

Group	Value	95% CI
THRIVE	21
Treatment as Usual	26

Acceptability of the Intervention Primary · 6 months

Mean duration of contact for participants who completed all four sessions

Group	Value	95% CI
THRIVE	135.5

Viral Load Improvement Secondary · 6 months

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

Group	Value	95% CI
THRIVE	12
Treatment as Usual	14

Number of Patients Who Are Retained in HIV Care Secondary · 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

Group	Value	95% CI
THRIVE	13
Treatment as Usual	16

Internalized AIDS-Related Stigma Scale (IARSS) Secondary · 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.

Group	Value	95% CI
THRIVE	2	2 – 5
Treatment as Usual	3	2 – 5

Depression Anxiety and Stress Scale (DASS-21). Secondary · 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.

DASS-21 Total

Group	Value	95% CI
THRIVE	28	16 – 48
Treatment as Usual	32	18 – 48

DASS-21 Depression

Group	Value	95% CI
THRIVE	8	4 – 14
Treatment as Usual	10	2 – 18

DASS-21 Stress

Group	Value	95% CI
THRIVE	10	6 – 16
Treatment as Usual	12	6 – 16

DASS-21 Anxiety

Group	Value	95% CI
THRIVE	8	2 – 18
Treatment as Usual	11	8 – 16

Alcohol Use Disorders Identification Test (AUDIT) Secondary · 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.

Alcohol use (at least monthly)

Group	Value	95% CI
THRIVE	8
Treatment as Usual	13

Consumption at Hazardous level

Group	Value	95% CI
THRIVE	6
Treatment as Usual	9

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

Ever Used Tobacco products

Group	Value	95% CI
THRIVE	10
Treatment as Usual	13

Ever Used Alcoholic beverages

Group	Value	95% CI
THRIVE	12
Treatment as Usual	20

Ever Used Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives

Group	Value	95% CI
THRIVE	20
Treatment as Usual	26

Used in past 3 months Tobacco products

Group	Value	95% CI
THRIVE	7
Treatment as Usual	11

Used in past 3 months Alcoholic beverages

Group	Value	95% CI
THRIVE	4
Treatment as Usual	3

Used in past 3 months Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives

Group	Value	95% CI
THRIVE	7
Treatment as Usual	7

Coping With HIV/AIDS Scale: Coping and Social Support Secondary · 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.

Coping with HIV - Positive Coping

Group	Value	95% CI
THRIVE	4	3 – 4
Treatment as Usual	3.5	1 – 4

Coping with HIV - Avoidance Coping

Group	Value	95% CI
THRIVE	3	1 – 5
Treatment as Usual	3	1 – 4

Coping With HIV/AIDS Scale Secondary · 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.

Seeking Social Support - Often/a lot for 1 of 2 items

Group	Value	95% CI
THRIVE	4
Treatment as Usual	4

Seeking Social Support - Often/a lot for 2 of 2 items

Group	Value	95% CI
THRIVE	2
Treatment as Usual	2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Dindo L, Moitra E, Roddy MK, Ratcliff C, et al · · 2022 · cited 1× · PMID 35628955 · DOI 10.3390/jcm11102827