Table 1 Comparison of the pair of trials evaluating the intervention developed during PRIME-SA
Characteristic | PRIME (Programme for Improving Mental Health CarE-SA) Trial | CobALT (Comorbid Affective Disorders, AIDS/HIV, 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 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 clinicians2. Supplementary training in the mental health components of PC1013. Clinic-based behavioural health 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 October 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 |