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

Study Overview
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Brief Summary
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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.

Official Title
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Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa: a Pragmatic Cluster Randomized Controlled Trial

Conditions
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HIV/AIDS, Depression, Chronic Diseases of Lifestyle

Intervention / Treatment
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* Other: Primary care 101 plus mental health
* Other: Standard Primary Care 101


Participation Criteria
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Eligibility Criteria
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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: Age ≥ 18 years and Receiving ART at the time of enrollment and Depressive symptoms, as indicated by a total score of 9 or more on the PHQ-9 and Planning to reside in the area for the next year and Capable of actively engaging in an interviewer-administered questionnaire at the time of recruitment, six and twelve months later and 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Care 101 Enhanced guideline<br>Primary Care 101 guideline with enhanced mental health | Other: Primary care 101 plus mental health<br>* A facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.<br>|
| Active Comparator: Standard of care<br>Primary Care 101 standard version guideline | Other: Standard Primary Care 101<br>* Standard Primary Care 101 guideline with standard training<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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