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.

Journal: BMJ open

Volume: 12

Issue: 12

Year of Publication: 2022

Affiliated Institutions:  Section of Epidemiology, Health Services and Population Research Department, King's College London, London, UK. Department of Primary Health Care Sciences, Unit of Mental Health, University of Zimbabwe, Harare, Zimbabwe. Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA. Department of Biostatistics and Health Informatics, King's College London, London, UK. Health Service and Population Research Department, Institute Of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Department of Psychiatry, University of Zimbabwe, Harare, Zimbabwe. Medical School Clinical Research Centre, University of Zimbabwe, Harare, Zimbabwe. Department of Psychology, University of Miami, Coral Gables, Florida, USA. Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA cocleirigh@mgh.harvard.edu.

Abstract summary 

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.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.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.NCT04018391.

Authors & Co-authors:  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

Study Outcome 

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Statistics
Citations :  Heestermans T, Browne JL, Aitken SC, et al. . Determinants of adherence to antiretroviral therapy among HIV-positive adults in sub-Saharan Africa: a systematic review. BMJ Glob Health 2016;1:e000125. 10.1136/bmjgh-2016-000125
Authors :  16
Identifiers
Doi : e057844
SSN : 2044-6055
Study Population
Male,Female
Mesh Terms
Humans
Other Terms
Depression & mood disorders;HEALTH ECONOMICS;HIV & AIDS;MENTAL HEALTH;PUBLIC HEALTH
Study Design
Study Approach
Country of Study
Zimbabwe
Publication Country
England