Characteristic | PRIME (PRogramme for Improving Mental health carE-SA) trial | CobALT (Co-morbid Affective Disorders and Long-term Health) trial |
---|---|---|
Setting | Dr. Kenneth Kaunda District, North West Province, South Africa | Dr. Kenneth Kaunda and Bojanala Districts, North West Province, South Africa |
Clinic participants | 20 primary care clinics | 40 primary care clinics |
Patient participants | Patients 18 years or older attending for hypertension treatment with a Patient Health Questionnaire score of 9 or more (n = 1000, 50 per clinic) | Patients 18 years or older attending for antiretroviral therapy (ART) with a Patient Health Questionnaire score of 9 or more (n = 2000, 50 per clinic) |
Number and unit of randomisation | 20 primary care clinics | 40 primary care clinics |
Trial participants | Patients 18 years or older attending for hypertension treatment with a Patient Health Questionnaire score of 9 or more (n = 1000, 50 per clinic) | Patients 18 years or older attending for ART with a Patient Health Questionnaire score of 9 or more (n = 2000, 50 per clinic) |
Control arm | The Integrated Services Delivery Model which includes distribution and training in the PC101 guide | Same |
Intervention arm | Three additional elements: 1. Clinical communications skills training for nurse clinicians 2. Supplementary training in the mental health components of PC101 3. Clinic-based behaviour-change counsellors equipped to provide morning talks on mental health to promote mental health literacy, manualised counselling for depression (8 sessions, individual or group) and adherence counselling (individual) | Same |
Primary mental health outcome | Response at 6 months, defined as a 50% improvement from baseline in the Patient Health Questionnaire 9 score | Same |
Primary clinical health outcome | Not applicable | Viral load suppression at 12 months |
Duration of fieldwork | April 2015 to December 2016 | April 2015 to December 2017 |
Controlled Trials Registration Number | NCT02425124 | NCT02407691 |
Funding | UK Department for International Development | National Institutes of Mental Health, United States of America |