Clinical trial NCT04201288: Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Official title: Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Medication adherence
Treatment adherence
HIV
Acceptance and Commitment Therapy
Retention
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-12-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention in medical care
timeFrame: 52 weeks
measure: Virologic suppression
timeFrame: 52 weeks
Secondary outcomes:
measure: Self-Rating Scale Item (SRSI) - Antiretroviral Treatment adherence
timeFrame: 52 weeks
measure: Brief HIV Disclosure and Safer Sex Self-Efficacy Scales (BHD)
timeFrame: 52 weeks
measure: The Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: 52 weeks
measure: HIV Stigma Scale (HSS)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Ethan Moitra, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: