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Completed

NCT Number: NCT04201288

Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Adherence and Compliance Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brown University

Providence, Rhode Island, 02912, United States

About this study

Drop-out rates from medical clinics in the first months following linkage to HIV care are as high as 50%, with 31-46% of patients dropping out after the first visit. People Living with HIV (PLWH) who are not consistently retained in care are at risk for: delayed antiretroviral treatment (ART) initiation, reduced ART adherence, unsuppressed viremia, and mortality. Moreover, poor retention means effective ART cannot be leveraged to prevent further HIV transmission. The objective of this study is to conduct a fully powered, randomized controlled trial (RCT) to assess the efficacy of a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to enhance retention in HIV care.

The aims of this proposal are: (1) To test, in a 2-arm RCT, the efficacy of the ABBT intervention on retention in care and virologic suppression (primary outcomes); and, ART adherence, disclosure of HIV status, perceived social support, HIV stigmatization (secondary outcomes), relative to an Enhanced-Treatment-as-Usual condition; and, (2) To examine the degree to which retention in HIV care and virologic suppression are mediated by (a) increased HIV acceptance (and decreased HIV experiential avoidance) and (b) increased willingness to disclose HIV status. The sample will consist of 270 HIV patients who are new to care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Cognitively impaired

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants Meeting Retention in HIV Medical Care Guidelines at 52 Weeks

    Time frame: 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.

  2. Number of Participants Who Met HIV Virologic Suppression

    Time frame: 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 health.

Secondary outcomes

  1. Self-Rating Scale Item (SRSI) - Antiretroviral Treatment Adherence

    Time frame: 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.

  2. Brief HIV Disclosure Scale (BHD)

    Time frame: 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.

  3. The Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: 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.

  4. HIV Stigma Scale (HSS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2019
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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