NCT04201288

Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2020-12-21
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2019-12-17
• Last updated: 2025-10-14
• Results posted: 2025-10-14

Locations

1 site across 1 country: United States