Dataset Information

Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial.

ABSTRACT:

Introduction

Non-adherence to antiretroviral therapy (ART) is the main cause of viral non-suppression and its risk is increased by depression. In countries with high burden of HIV, there is a lack of trained professionals to deliver depression treatments. This paper describes the protocol for a 2-arm parallel group superiority 1:1 randomised controlled trial, to test the effectiveness and cost effectiveness of the TENDAI stepped care task-shifted intervention for depression, ART non-adherence and HIV viral suppression delivered by lay interventionists.

Methods and analysis

Two hundred and ninety people living with HIV aged ≥18 years with probable depression (Patient Health Questionnaire=>10) and viral non-suppression (≥ 1000 HIV copies/mL) are being recruited from HIV clinics in towns in Zimbabwe. The intervention group will receive a culturally adapted 6-session psychological treatment, Problem-Solving Therapy for Adherence and Depression (PST-AD), including problem-solving therapy, positive activity scheduling, skills to cope with stress and poor sleep and content to target barriers to non-adherence to ART. Participants whose score on the Patient Health Questionnaire-9 remains ≥10, and/or falls by less than 5 points, step up to a nurse evaluation for possible antidepressant medication. The control group receives usual care for viral non-suppression, consisting of three sessions of adherence counselling from existing clinic staff, and enhanced usual care for depression in line with the WHO Mental Health Gap intervention guide. The primary outcome is viral suppression (<1000 HIV copies/mL) at 12 months post-randomisation.

Ethics and dissemination

The study and its tools were approved by MRCZ/A/2390 in Zimbabwe and RESCM-18/19-5580 in the UK. Study findings will be shared through the community advisory group, conferences and open access publications.

Trial registration number

NCT04018391.

SUBMITTER: Abas M

PROVIDER: S-EPMC9723911 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial.

Abas Melanie M Mangezi Walter W Nyamayaro Primrose P Jopling Rebecca R Bere Tarisai T McKetchnie Samantha M SM Goldsmith Kimberley K Fitch Calvin C Saruchera Emily E Muronzie Thabani T Gudyanga Denford D Barrett Barbara M BM Chibanda Dixon D Hakim James J Safren Steven A SA O'Cleirigh Conall C

BMJ open 20221205 12

<h4>Introduction</h4>Non-adherence to antiretroviral therapy (ART) is the main cause of viral non-suppression and its risk is increased by depression. In countries with high burden of HIV, there is a lack of trained professionals to deliver depression treatments. This paper describes the protocol for a 2-arm parallel group superiority 1:1 randomised controlled trial, to test the effectiveness and cost effectiveness of the TENDAI stepped care task-shifted intervention for depression, ART non-adhe ...[more]

PMID: 36576191

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Project description:BACKGROUND:Youth living with HIV (YLWH) are confronted with many self-care challenges that can be experienced as overwhelming in the context of normal developmental processes that characterize adolescence and young adulthood. A sizable minority of YLWH have unsuppressed viral loads in the United States attributable to antiretroviral therapy (ART) nonadherence. Interventions to promote sustained viral suppression in YLWH are needed. OBJECTIVE:The aim of this study is to evaluate the efficacy of the Triggered Escalating Real-Time Adherence (TERA) intervention in comparison with standard of care (SOC) in YLWH (aged 13-24 years) failing ART on (1) primary outcome measures-HIV viral suppression (VLS), defined as both <200 copies/ml and <50 copies/ml at 12 weeks, and (2) secondary outcome measures-VLS rates and rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time as measured by an electronic dose monitoring (EDM) device. METHODS:The TERA study is a phase 2, multisite clinical trial conducted with 120 YLWH failing ART (randomized 1:1 to TERA or SOC) at participating clinical sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). Participants are followed for a total of 48 weeks. For TERA arm participants, the first 12 weeks involve delivery of the intervention. For all participants, clinical outcomes are collected throughout follow-up, and adherence is assessed using EDM over the full 48 weeks. During the 12-week intervention period, TERA arm participants receive 3 remote coaching sessions delivered in clinic via videoconferencing timed to coincide with baseline and follow-up clinical visits, text message reminders when the EDM has not been opened at dose time (which escalate to 2-way theory-informed short message service coaching interactions in response to real-time nonadherence), and review of dosing graphs produced by EDM at follow-up visits. RESULTS:Launch dates for enrollment varied by site. Enrollment began in April 2018 and is expected to be completed by August 2019, with results presented by the second quarter of 2021. CONCLUSIONS:Effective, generalizable, and scalable approaches to rapidly assist YLWH failing to achieve and sustain VLS may have a substantial impact on individual health and efforts to curb transmission. Coaching for a brief but intensive period from remote coaches and using communication channels common to youth may offer multiple unique advantages in promoting self-care. TRIAL REGISTRATION:ClinicalTrials.gov NCT03292432; https://clinicaltrials.gov/ct2/show/NCT03292432 (Archived by WebCite at http://www.webcitation.org/768J8ijjp). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/11416.

Dataset Information

Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial.

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