Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

HIV/AIDS Clinical Trial

Official title:

Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04201288
• Other study ID #: 1908002504
• Secondary ID: R01MH119919
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2023
• Source: Brown University
• Contact: Debra Herman, Ph.D.
• Phone: 401-455-6652
• Email: DHerman[@]Butler.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: November 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in medical care	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
Primary	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.	52 weeks
Secondary	Self-Rating Scale Item (SRSI) - Antiretroviral Treatment adherence	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.	52 weeks
Secondary	Brief HIV Disclosure and Safer Sex Self-Efficacy Scales (BHD)	The BHD HIV disclosure subscale 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.	52 weeks
Secondary	The Multidimensional Scale of Perceived Social Support (MSPSS)	The MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support.	52 weeks
Secondary	HIV Stigma Scale (HSS)	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.	52 weeks