Trial Outcomes & Findings for Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE') (NCT NCT04481373)

NCT ID: NCT04481373

Last Updated: 2025-10-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

6 months

Results posted on

2025-10-14

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
39
36
Overall Study
COMPLETED
35
35
Overall Study
NOT COMPLETED
4
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Protocol Violation
1
0
Overall Study
Viral load in hospital not over 1000
2
1
Overall Study
Death before hospital discharge
1
0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
THRIVE
n=35 Participants
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.
Treatment as Usual
n=35 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Total
n=70 Participants
Total of all reporting groups
Age, Continuous
47.2 Years
STANDARD_DEVIATION 12.3 • n=99 Participants
42.1 Years
STANDARD_DEVIATION 11.8 • n=107 Participants
44.7 Years
STANDARD_DEVIATION 12.1 • n=206 Participants
Sex: Female, Male
Female
8 Participants
n=99 Participants
7 Participants
n=107 Participants
15 Participants
n=206 Participants
Sex: Female, Male
Male
27 Participants
n=99 Participants
28 Participants
n=107 Participants
55 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
18 Participants
n=99 Participants
20 Participants
n=107 Participants
38 Participants
n=206 Participants
Race (NIH/OMB)
White
15 Participants
n=99 Participants
13 Participants
n=107 Participants
28 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
9 Participants
n=99 Participants
9 Participants
n=107 Participants
18 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants
n=99 Participants
26 Participants
n=107 Participants
52 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Coping with HIV/AIDS Scale - Positive Coping
2 units on a scale
n=99 Participants
3 units on a scale
n=107 Participants
2 units on a scale
n=206 Participants
Coping with HIV/AIDS Scale - Avoidance Coping
2 units on a scale
n=99 Participants
3 units on a scale
n=107 Participants
3 units on a scale
n=206 Participants
Coping with HIV/AIDS Scale - Seeking Social Support Subscale
Seeking Social Support - "Often" or "a lot" for 1 of the 2 subscale items
10 Participants
n=99 Participants
6 Participants
n=107 Participants
16 Participants
n=206 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 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
Internalized AIDS-Related Stigma Scale (IARSS)
2 units on a scale
n=99 Participants
3 units on a scale
n=107 Participants
3 units on a scale
n=206 Participants
Depression Anxiety and Stress Scale (DASS-21)
DASS-21 Depression
8 units on a scale
n=99 Participants
10 units on a scale
n=107 Participants
10 units on a scale
n=206 Participants
Depression Anxiety and Stress Scale (DASS-21)
DASS-21 Stress
10 units on a scale
n=99 Participants
10 units on a scale
n=107 Participants
10 units on a scale
n=206 Participants
Depression Anxiety and Stress Scale (DASS-21)
DASS-21 Anxiety
10 units on a scale
n=99 Participants
10 units on a scale
n=107 Participants
10 units on a scale
n=206 Participants
Depression Anxiety and Stress Scale (DASS-21)
DASS Total
26 units on a scale
n=99 Participants
36 units on a scale
n=107 Participants
31 units on a scale
n=206 Participants
AUDIT (Hazardous Alcohol Use)
Alcohol use (at least monthly)
20 Participants
n=99 Participants
10 Participants
n=107 Participants
30 Participants
n=206 Participants
AUDIT (Hazardous Alcohol Use)
Consumption at Hazardous level
7 Participants
n=99 Participants
6 Participants
n=107 Participants
13 Participants
n=206 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Tobacco products
19 Participants
n=99 Participants
23 Participants
n=107 Participants
42 Participants
n=206 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Alcoholic beverages
29 Participants
n=99 Participants
27 Participants
n=107 Participants
56 Participants
n=206 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Cannabis/Cocaine/Amphetamine/Inhalants/S
35 Participants
n=99 Participants
33 Participants
n=107 Participants
68 Participants
n=206 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Tobacco products
14 Participants
n=99 Participants
10 Participants
n=107 Participants
24 Participants
n=206 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Alcoholic beverages
7 Participants
n=99 Participants
2 Participants
n=107 Participants
9 Participants
n=206 Participants
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Cannabis/Cocaine/Amphetamine
7 Participants
n=99 Participants
5 Participants
n=107 Participants
12 Participants
n=206 Participants

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure
THRIVE
n=39 Participants
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.
Treatment as Usual
n=36 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Acceptability of Enrollment and Randomization: Eligible But Declined Participation
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure
THRIVE
n=35 Participants
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.
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.
Acceptability of Enrollment and Randomization: Completion Sessions
28 Participants
0 Participants

PRIMARY outcome

Timeframe: 6 months

The completion of participant 6-month follow-up assessments

Outcome measures

Outcome measures
Measure
THRIVE
n=35 Participants
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.
Treatment as Usual
n=35 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Acceptability of the Intervention: 6 Month Follow-up
21 Participants
26 Participants

PRIMARY outcome

Timeframe: 6 months

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

Mean duration of contact for participants who completed all four sessions

Outcome measures

Outcome measures
Measure
THRIVE
n=25 Participants
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.
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.
Acceptability of the Intervention
135.5 minutes

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure
THRIVE
n=31 Participants
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.
Treatment as Usual
n=32 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Viral Load Improvement
12 Participants
14 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
THRIVE
n=33 Participants
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.
Treatment as Usual
n=32 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Number of Patients Who Are Retained in HIV Care
13 Participants
16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
THRIVE
n=21 Participants
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.
Treatment as Usual
n=26 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Internalized AIDS-Related Stigma Scale (IARSS)
2 units on a scale
Interval 2.0 to 5.0
3 units on a scale
Interval 2.0 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
THRIVE
n=21 Participants
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.
Treatment as Usual
n=26 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Depression Anxiety and Stress Scale (DASS-21).
DASS-21 Total
28 units on a scale
Interval 16.0 to 48.0
32 units on a scale
Interval 18.0 to 48.0
Depression Anxiety and Stress Scale (DASS-21).
DASS-21 Depression
8 units on a scale
Interval 4.0 to 14.0
10 units on a scale
Interval 2.0 to 18.0
Depression Anxiety and Stress Scale (DASS-21).
DASS-21 Stress
10 units on a scale
Interval 6.0 to 16.0
12 units on a scale
Interval 6.0 to 16.0
Depression Anxiety and Stress Scale (DASS-21).
DASS-21 Anxiety
8 units on a scale
Interval 2.0 to 18.0
11 units on a scale
Interval 8.0 to 16.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
THRIVE
n=21 Participants
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.
Treatment as Usual
n=26 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Alcohol Use Disorders Identification Test (AUDIT)
Alcohol use (at least monthly)
8 Participants
13 Participants
Alcohol Use Disorders Identification Test (AUDIT)
Consumption at Hazardous level
6 Participants
9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
THRIVE
n=21 Participants
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.
Treatment as Usual
n=26 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Alcoholic beverages
4 Participants
3 Participants
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Tobacco products
10 Participants
13 Participants
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Alcoholic beverages
12 Participants
20 Participants
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Ever Used Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives
20 Participants
26 Participants
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Tobacco products
7 Participants
11 Participants
The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Used in past 3 months Cannabis/Cocaine/Amphetamine/Inhalants/Sedatives
7 Participants
7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
THRIVE
n=21 Participants
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.
Treatment as Usual
n=26 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Coping With HIV/AIDS Scale: Coping and Social Support
Coping with HIV - Positive Coping
4 Medan, ICR
Interval 3.0 to 4.0
3.5 Medan, ICR
Interval 1.0 to 4.0
Coping With HIV/AIDS Scale: Coping and Social Support
Coping with HIV - Avoidance Coping
3 Medan, ICR
Interval 1.0 to 5.0
3 Medan, ICR
Interval 1.0 to 4.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
THRIVE
n=21 Participants
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.
Treatment as Usual
n=26 Participants
Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
Coping With HIV/AIDS Scale
Seeking Social Support - Often/a lot for 1 of 2 items
4 Participants
4 Participants
Coping With HIV/AIDS Scale
Seeking Social Support - Often/a lot for 2 of 2 items
2 Participants
2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 weeks

Population: CSQ was only measured in the THRIVE arm.

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.

Outcome measures

Outcome measures
Measure
THRIVE
n=27 Participants
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.
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.
Client Satisfaction Questionnaire (CSQ)
31 units on a scale
Interval 26.0 to 31.0

Adverse Events

THRIVE

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Treatment as Usual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Giordano

Baylor College of Medicine

Phone: 7137988918

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place