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;
COMPLETED
NA
75 participants
6 months
2025-10-14
Participant Flow
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
| 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
| 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 monthsThe number of eligible PWH who agree and decline to participate, and reasons for declining;
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 monthsPopulation: 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
| 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 monthsThe completion of participant 6-month follow-up assessments
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 monthsPopulation: Treatment as usual participants did not get any intervention.
Mean duration of contact for participants who completed all four sessions
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 monthsViral load less than 200 copies/mL at 180 days +/- 42 days of follow up
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 monthsNumber 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
| 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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 weeksPopulation: 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
| 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
Treatment as Usual
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place