COBALT (CO-morBidity of AIDS/ HIV Affective disorder, and Long-Term Health) is a pragmatic cluster randomised controlled trial in public sector primary care clinics in the North West province of South Africa.
The trial will evaluate the effectiveness of a facility-based intervention combining depression case detection by non-physician clinicians (in this setting, nurses) with individual and group psychosocial counselling for depression delivered by lay-health workers, on mental health and HIV outcomes in depressed adults receiving antiretroviral treatment (ART).
COBALT is a five year project with 40 primary care clinics in two districts of the North West province being randomised either to receive the intervention or to continue with usual care. Data will be collected at a patient level, with 2000 patient participants being interviewed at three time points (baseline, 6 and 12 months) between April 2015 and November 2017.
The primary outcomes will be depression symptoms measured at 6 months and viral load blood tests measured at 12 months. Secondary outcome measures will include adherence to ART medication, risk factors for cardiovascular disease (blood pressure, body mass index and smoking status) and cost effectiveness of the intervention.
The trial is designed to provide vital evidence on how integrated multi-disease management can be achieved within resource constrained settings. This evidence will also have important implications internationally, especially for other low and middle-income countries as ART becomes more available.
COBALT is funded by the National Institute of Mental Health, National Institutes of Health (NIH). Ethical approval for the study has been obtained from the University of Cape Town Human Research Ethics Committee, the University of KwaZulu-Natal Biomedical Research Ethics Committee, and the King’s College London Research Ethics Committee. The principal investigators are Prof Graham Thornicroft, King’s College London; Dr Lara Fairall, University of Cape Town Lung Institute; and Prof Inge Petersen, University of KwaZulu-Natal.
The goal of the PRogramme for Improving Mental health carE (PRIME) is to generate research evidence on the implementation and scaling-up of treatment programmes for mental disorders in low resource settings. PRIME is a multi-country initiative supported by the Department for International Development (DFID), and is a six year programme which was launched in May 2011.
PRIME South Africa is being conducted in the North West Province. The initiative includes the stepped-care intervention described above, aimed at improving the diagnosis and management of depression in patients attending public sector primary care clinics. A pragmatic cluster randomsied controlled trial will be conducted alongside the COBALT trial to evaluate the stepped-care intervention on mental health and hypertension outcomes in depressed adults receiving antihypertensive medication.