Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial

Trials

the CobALT research team¹  Crick Lund²  Carl Lombard³  Thomas Gaziano⁴  Graham Thornicroft⁵  One Selohilwe⁶  Ntokozo Mntambo⁶  Inge Petersen⁶  Tasneem Kathree⁶  Arvin Bhana⁶  Ruwayda Petrus⁶  Naomi Levitt⁷  Sergio Carmona⁸  Max Bachmann⁹  Jill Hanass-Hancock^1,10  Paul McCrone^1,11  Lara Fairall^1,12  Naomi Folb^1,12  Babalwa Zani^1,12  Daniella Georgeu-Pepper^1,12  Daniel Chisholm^1,13 

[1] ;Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town;Biostatistics Unit, South African Medical Research Council;Cardiovascular Medicine, Brigham & Women’s Hospital;Centre for Global Mental Health, Institute of Psychiatry, Psychology and Neuroscience, King′s College London;Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal;Department of Medicine, University of Cape Town;Department of Molecular Medicine and Haematology, University of the Witwatersrand, National Health Laboratory Service;Department of Population Health and Primary Care, Norwich Medical School, University of East Anglia;HIV Prevention Research Unit, South African Medical Research Cuncil;King’s Health Economics, Institute of Psychiatry, Psychology & Neuroscience, King’s College London;Knowledge Translation Unit, University of Cape Town Lung Institute;World Health Organization Regional Office for Europe;

关键词: Antiretroviral therapy;    Viral load;    Depression;    Mental health gap;    Primary healthcare;    Pragmatic trials;   

DOI  :  10.1186/s13063-018-2517-7

来源: DOAJ

【 摘 要 】

Abstract Background The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. Methods The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health’s Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women’s health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. Discussion The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. Trial registration ClinicalTrials.gov (NCT02407691) registered on 19 March 2015; Pan African Clinical Trials Registry (201504001078347) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) (DOH-27-0515-5048) NHREC number 4048 issued on 21/04/2015.

【 授权许可】

Unknown