Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

Brown University

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: Acceptance-Based Behavior Therapy (ABBT); Behavioral: Enhanced-Treatment-as-Usual (ETAU)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04201288

1908002504

R01MH119919 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HIV+
2. ≥18 years old
3. Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
4. Able to speak and read English at the level to be able to complete the study procedures
5. Have telephone access.

Exclusion criteria

1. Cognitively impaired

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups, including a placebo group

Acceptance-Based Behavior Therapy (ABBT)

Experimental group

Description:

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

Treatment:

Behavioral: Acceptance-Based Behavior Therapy (ABBT)

Enhanced-Treatment-as-Usual (ETAU)

Placebo Comparator group

Description:

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

Treatment:

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