Fairall 2018.

Study name	Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa
Methods	Cluster‐randomised controlled trial
Participants	Clusters: 40 nurse‐led primary care clinics providing ART in the Dr Kenneth Kaunda and Bojonala districts of the North West Province, South Africa Inclusion criteria 1. Age ≥ 18 years 2. Receiving ART at time of enrolment 3. Depressive symptoms, as indicated by total score ≥ 9 or more on the PHQ‐9 4. Planning to reside in the area for the next year 5. Capable of actively engaging in an interviewer‐administered questionnaire at the time of recruitment and 3, 6, and 12 months later 6. Written consent to participate in the study Exclusion criteria 1. Clinics a. Clinics that participate in formative research and piloting of the intervention 2. Patients a. Inability to meet the above inclusion criteria
Interventions	Intervention Primary Care 101 Plus Supplementary training in PC101+ focusing on (1) increasing nurse capacity to detect and manage non‐communicable diseases, specifically, depression, cardiovascular disease, diabetes, and alcohol misuse among patients receiving lifelong ART; and (2) providing a group counselling intervention for depression for these participants Control Primary Care 101 Provision of the standard version of the PC101 guideline, excluding mental health and standard training
Outcomes	Primary outcome 1. PHQ‐9 response defined as ≥ 50% improvement in baseline score Secondary outcomes 1. PHQ‐9 including response at 12 months 2. PHQ‐9 mean scores at 6 and 12 months 3. Remission, defined as PHQ‐9 score ≤ 5 at 12 months 4. Category of depression severity based on PHQ‐9 (mild, moderate, severe) at 6 and 12 months 5. Treatment for depression, including initiation or intensification of antidepressant medication, referral to a counsellor for depression counselling, number of contacts with a counsellor, and referral to a mental health specialist (clinical psychologist, psychiatrist, or secondary care services) 6. Perceived Stress Scale 7.HIV viral suppression at 12 months defined as viral load < 400 copies/mL, virologic failure defined as 2 consecutive viral load values > 1000 copies/mL, change in viral load values over time 8. Antiretroviral therapy programme retention 9. Appropriate maintenance on enrolment ART regimen 10. ART regimen switched to second line 11. Internalised AIDS Related Stigma Scale 12. Adherence to ART medication (30‐day VAS self‐reported measure) 13. Risk factors for cardiovascular diseases (blood pressure, weight, smoking status) 14. Detection and treatment of other chronic disease 15. Mortality (mortality reported at loss to follow‐up or through the South African Population register) 16. Hospital admissions (number and duration of overnight hospital stays) 17. Care utilisation and resource use 18. Provision of integrated care from patient perspective will be assessed using the Patient Assessment of Care for Chronic Conditions (PACIC)
Starting date	16/4/2015
Contact information	lara.fairall@uct.ac.za
Notes	Also registered as NCT02407691 at ClinicalTrials.gov