Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

NCT04201288 | Completed Results DMC

• 2 other identifiers: 1908002504R01MH119919
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV/AIDS

Keywords

Medication adherence; Treatment adherence; HIV; Acceptance and Commitment Therapy; Retention

Outcome Measures

Primary Outcomes (2)

• Number of Participants Meeting Retention in HIV Medical Care Guidelines at 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.

  52 weeks

• Number of Participants Who Met HIV Virologic Suppression

  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 health.

  52 weeks

Secondary Outcomes (4)

• Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence

  52 weeks

• Brief HIV Disclosure Scale (BHD)

  52 weeks

• The Multidimensional Scale of Perceived Social Support (MSPSS)

  52 weeks

• HIV Stigma Scale (HSS)

  52 weeks

Study Arms (2)

Acceptance-Based Behavior Therapy (ABBT)

EXPERIMENTAL

The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.

Behavioral: Acceptance-Based Behavior Therapy (ABBT)

Enhanced-Treatment-as-Usual (ETAU)

PLACEBO COMPARATOR

In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.

Behavioral: Enhanced-Treatment-as-Usual (ETAU)

Interventions

Acceptance-Based Behavior Therapy (ABBT) BEHAVIORAL

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.

Acceptance-Based Behavior Therapy (ABBT)

Enhanced-Treatment-as-Usual (ETAU) BEHAVIORAL

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.

Enhanced-Treatment-as-Usual (ETAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+
• ≥18 years old
• Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
• Able to speak and read English at the level to be able to complete the study procedures
• Have telephone access.

You may not qualify if:

• \. Cognitively impaired

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Behavior

Results Point of Contact

• Title: Ethan Moitra, Associate Professor of Psychiatry and Human Behavior
• Organization: Brown University

ethan_moitra@brown.edu

401-444-1949

Study Officials

• Ethan Moitra, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: December 21, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared upon the completion of the study and after summary data are published in a peer-reviewed journal. Consistent with NIMH guidelines, there will be no specific time limit regarding how long IPD are available.
• Access Criteria: Request to access the data will be evaluated by the PI to ensure that they meet reasonable standards of scientific integrity.

Locations

US (1)