Trial Outcomes & Findings for Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients (NCT NCT04201288)
NCT ID: NCT04201288
Last Updated: 2025-10-14
Results Overview
Objective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
52 weeks
Results posted on
2025-10-14
Participant Flow
Recruitment occurred during routine intake at HIV clinics in Minneapolis, New Orleans, and Providence from December 2021 through March 2024.
Randomization was stratified by active substance use and depression severity.
Participant milestones
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
16
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Baseline characteristics by cohort
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
n=20 Participants
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
n=16 Participants
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Addiction Severity Index
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
AUDIT-C
|
3.7 units on a scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksObjective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period.
Outcome measures
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
n=20 Participants
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
n=16 Participants
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
|---|---|---|
|
Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks
|
20 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 52 weeksObjective data from participants' electronic health records will be obtained to examine their viral load, which is a blood-based measure of the amount of HIV viruses in the person's body. If participants are not currently retained in medical care and blood sample results are not available in their electronic health record, they will submit 1-3ml of blood at each assessment through the study's research phlebotomist. A viral load that measures as "undetectable" (i.e., fewer than 200 copies of HIV per millilitre of blood) will represent virologic suppression, which is a positive indication of HIV health.
Outcome measures
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
n=20 Participants
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
n=16 Participants
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
|---|---|---|
|
Number of Participants Who Met HIV Virologic Suppression
|
20 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 52 weeksSelf-report data of participants' HIV antiretroviral treatment adherence will be obtained with the SRSI. Scores range from 0 to 5, which correspond to "very poor" to "excellent" medication adherence.
Outcome measures
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
n=13 Participants
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
n=12 Participants
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
|---|---|---|
|
Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence
|
4.5 score on a scale
Standard Deviation 0.7
|
4.6 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 52 weeksThe BHD HIV disclosure scale will be used to assess for willingness to make informed disclosure and for actual disclosure of HIV status. Scores range from 8-32, with higher scores indicating increased willingness to disclose.
Outcome measures
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
n=13 Participants
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
n=12 Participants
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
|---|---|---|
|
Brief HIV Disclosure Scale (BHD)
|
21.3 units on a scale
Standard Deviation 3.2
|
22.1 units on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 52 weeksThe MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support.
Outcome measures
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
n=13 Participants
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
n=12 Participants
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
|---|---|---|
|
The Multidimensional Scale of Perceived Social Support (MSPSS)
|
5.8 units on a scale
Standard Deviation 0.7
|
5.3 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 52 weeksThe HSS will be used to measure self-reported experiences, fear, and perception of stigmatization due to being HIV+. Scores range from 6-24, with lower scores indicating less fear or concern about stigmatization.
Outcome measures
| Measure |
Acceptance-Based Behavior Therapy (ABBT)
n=13 Participants
The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.
Acceptance-Based Behavior Therapy (ABBT): Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
|
Enhanced-Treatment-as-Usual (ETAU)
n=12 Participants
In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Enhanced-Treatment-as-Usual (ETAU): ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
|
|---|---|---|
|
HIV Stigma Scale (HSS)
|
19.5 units on a scale
Standard Deviation 4.5
|
21.1 units on a scale
Standard Deviation 5.0
|
Adverse Events
Acceptance-Based Behavior Therapy (ABBT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Enhanced-Treatment-as-Usual (ETAU)
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
Ethan Moitra, Associate Professor of Psychiatry and Human Behavior
Brown University
Phone: 401-444-1949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place