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

Not Applicable

Completed

• Conditions: Chronic Diseases of Lifestyle; HIV/AIDS; Depression
• Interventions: Other: Primary care 101 plus mental health; Other: Standard Primary Care 101

• Registration Number: NCT02407691
• Lead Sponsor: University of Cape Town

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-19
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2002

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Care 101 Enhanced guideline	Primary care 101 plus mental health	Primary Care 101 guideline with enhanced mental health
Standard of care	Standard Primary Care 101	Primary Care 101 standard version guideline

Primary Outcome Measures

Name	Time	Method
Viral load suppression	12 months	viral load value of \<1000 RNA copies/ml
Patient Health Questionnaire 9 (PHQ-9) response	6 months	At least 50% improvement in PHQ-9 score compared with baseline

Secondary Outcome Measures

Name	Time	Method
Mean PHQ-9 score at 6 and 12 months	6 and 12 months	Average score in the PHQ-9
PHQ-9 Response at 12 months	12 months	At least 50% improvement in PHQ-9 score compared with baseline
Depression Remission at 12 months	12 months	Score of less than 5 in PHQ-9
Antiretroviral therapy programme retention	12 months	continuation in the ART programme
Viral load suppression at 12 months	12 months	Defined as a viral load of \<400 copies/ml
Virological failure	12 months	Defined as two viral load values \>1000 copies/ml
Appropriate maintenance on enrollment ART regimen OR ART regimen switched to second-line	12 months	continuation with the ART regimen OR change
ART adherence	12 months	30 day VAS self reported measure
Change in viral load values over time	12 months	change in HIV RNA copies measured by PCR
Depression severity (categorised as mild, moderate, moderately severe or severe depression at 6 and 12 months)	6 and 12 months	Mild depression defined as a score of 5 to 9; moderate depression defined as a score of 10-14 Moderately severe depression defines as a core of 15-19, and Severe depression defined as a score of 20-27.
Antidepressant treatment initiated or intensified	12 months	start or intensification of anti-depressants after baseline
Counselling for depression by a clinic-based counsellor	12 months	Having counselling sessions with the clinic counsellor
Referral to specialist mental health worker/service	12 months	Referral by a nurse to mental health worker/service
Hospital admissions	12 months	number and duration of overnight hospital stays
Mortality	12 months	Mortality reported at loss to follow-up or through the South African Population register
Stress	12 months	Measured through the Percieved Stress Scale
Risk factors for cardiovascular diseases	12 months	Measured by blood pressure, weight, smoking status
Detection and treatment of other chronic diseases	12 months	Identification of new cases of NCDs or risk factors of Chronic deseases
Stigma	12 months	Measured through the 6-item AIDS related stigma scale
Provision of integrated care from patient perspective	12 months	Assessed using the Patient Assessment of Care for Chronic Conditions (PACIC)

Trial Locations

Locations (2)

Bojanala District; 🇿🇦 Rustenburg, North West, South Africa

Dr Kenneth Kaunda District; 🇿🇦 Klerksdorp, North West, South Africa