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NCT04201288

Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

Completed NA Results posted Last updated 14 October 2025
What this trial tests

NA trial testing Acceptance-Based Behavior Therapy (ABBT) in HIV/AIDS in 38 participants. Completed in 31 March 2025.

Timeline
21 December 2020
Primary endpoint
31 March 2025
31 March 2025

Quick facts

Lead sponsorBrown University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment38
Start date21 December 2020
Primary completion31 March 2025
Estimated completion31 March 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brown University

Who can join

18 and older, any sex, with HIV/AIDS. 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.

Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks Primary · 52 weeks

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.

GroupValue95% CI
Acceptance-Based Behavior Therapy (ABBT)20
Enhanced-Treatment-as-Usual (ETAU)16
Number of Participants Who Met HIV Virologic Suppression Primary · 52 weeks

Objective 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

GroupValue95% CI
Acceptance-Based Behavior Therapy (ABBT)20
Enhanced-Treatment-as-Usual (ETAU)14
Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence Secondary · 52 weeks

Self-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.

GroupValue95% CI
Acceptance-Based Behavior Therapy (ABBT)4.5± 0.7
Enhanced-Treatment-as-Usual (ETAU)4.6± 0.7
Brief HIV Disclosure Scale (BHD) Secondary · 52 weeks

The 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.

GroupValue95% CI
Acceptance-Based Behavior Therapy (ABBT)21.3± 3.2
Enhanced-Treatment-as-Usual (ETAU)22.1± 4.2
The Multidimensional Scale of Perceived Social Support (MSPSS) Secondary · 52 weeks

The MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support.

GroupValue95% CI
Acceptance-Based Behavior Therapy (ABBT)5.8± 0.7
Enhanced-Treatment-as-Usual (ETAU)5.3± 0.9
HIV Stigma Scale (HSS) Secondary · 52 weeks

The 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.

GroupValue95% CI
Acceptance-Based Behavior Therapy (ABBT)19.5± 4.5
Enhanced-Treatment-as-Usual (ETAU)21.1± 5.0

Sponsor's own description

The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care. The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Acceptance-Based Behavior Therapy (ABBT)

Trials testing the same drug.

Other recruiting trials for HIV/AIDS

Currently open trials in the same condition.

Other Brown University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04201288.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing