Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa (COBALT)

University of Cape Town (UCT)

Status: Completed

Conditions: Chronic Diseases of Lifestyle; Depression; HIV/AIDS

Treatments: Other: Primary care 101 plus mental health; Other: Standard Primary Care 101

Study type: Interventional

Funder types: Other

Identifiers

NCT02407691

1R01MH100470-01

Details and patient eligibility

About

With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned from a terminal illness to a long-term condition. It is likely to be accompanied by higher levels of disability and other chronic non-communicable diseases, resulting from the HIV itself, as well as adverse effects of medication. This requires an expansion of the purview of HIV care beyond direct HIV clinical care to also include a more comprehensive and integrated package of treatment and care for physical and mental conditions and their consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public sector primary care clinics in the North West Province of SA. It will assess mental health and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness of a facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.

Enrollment: 2,002 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Clinics:

1. 40 nurse-led primary care clinics providing ART in the Dr Kenneth Kaunda and Bojonala districts of the North West Province, South Africa

Patients:

1. Age ≥ 18 years and
2. Receiving ART at the time of enrollment and
3. Depressive symptoms, as indicated by a total score of 9 or more on the PHQ-9 and
4. Planning to reside in the area for the next year and
5. Capable of actively engaging in an interviewer-administered questionnaire at the time of recruitment, six and twelve months later and
6. Written consent to participate in the study

Exclusion criteria

Clinics:

1. Clinics which participate in the formative research and piloting of the intervention

Patients:

1. Inability to meet the above inclusion criteria

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,002 participants in 2 patient groups

Primary Care 101 Enhanced guideline

Experimental group

Description:

Primary Care 101 guideline with enhanced mental health

Treatment:

Other: Primary care 101 plus mental health

Standard of care

Active Comparator group

Description:

Primary Care 101 standard version guideline

Treatment:

Other: Standard Primary Care 101