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

Depression Clinical Trial

— COBALT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407691
• Other study ID #: 1R01MH100470-01
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: January 2018

Study information

• Verified date: November 2023
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2002
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases of Lifestyle
• Depression
• Depressive Disorder
• HIV/AIDS

Intervention

Other:
• Primary care 101 plus mental health
A facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.
• Standard Primary Care 101
Standard Primary Care 101 guideline with standard training

Locations

Country	Name	City	State
South Africa	Dr Kenneth Kaunda District	Klerksdorp	North West
South Africa	Bojanala District	Rustenburg	North West

Sponsors (3)

Lead Sponsor	Collaborator
University of Cape Town	King's College London, University of KwaZulu

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disability	Measured by WHODAS 2	12 months
Other	Care utilization and resource use	Measured by service use questionnaire	12 months
Other	Productivity and economic measures	Self reported	12 months
Primary	Viral load suppression	viral load value of <1000 RNA copies/ml	12 months
Primary	Patient Health Questionnaire 9 (PHQ-9) response	At least 50% improvement in PHQ-9 score compared with baseline	6 months
Secondary	PHQ-9 Response at 12 months	At least 50% improvement in PHQ-9 score compared with baseline	12 months
Secondary	Depression Remission at 12 months	Score of less than 5 in PHQ-9	12 months
Secondary	Mean PHQ-9 score at 6 and 12 months	Average score in the PHQ-9	6 and 12 months
Secondary	Antiretroviral therapy programme retention	continuation in the ART programme	12 months
Secondary	Viral load suppression at 12 months	Defined as a viral load of <400 copies/ml	12 months
Secondary	Virological failure	Defined as two viral load values >1000 copies/ml	12 months
Secondary	Appropriate maintenance on enrollment ART regimen OR ART regimen switched to second-line	continuation with the ART regimen OR change	12 months
Secondary	ART adherence	30 day VAS self reported measure	12 months
Secondary	Change in viral load values over time	change in HIV RNA copies measured by PCR	12 months
Secondary	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
Secondary	Antidepressant treatment initiated or intensified	start or intensification of anti-depressants after baseline	12 months
Secondary	Counselling for depression by a clinic-based counsellor	Having counselling sessions with the clinic counsellor	12 months
Secondary	Referral to specialist mental health worker/service	Referral by a nurse to mental health worker/service	12 months
Secondary	Hospital admissions	number and duration of overnight hospital stays	12 months
Secondary	Mortality	Mortality reported at loss to follow-up or through the South African Population register	12 months
Secondary	Stress	Measured through the Percieved Stress Scale	12 months
Secondary	Stigma	Measured through the 6-item AIDS related stigma scale	12 months
Secondary	Risk factors for cardiovascular diseases	Measured by blood pressure, weight, smoking status	12 months
Secondary	Detection and treatment of other chronic diseases	Identification of new cases of NCDs or risk factors of Chronic deseases	12 months
Secondary	Provision of integrated care from patient perspective	Assessed using the Patient Assessment of Care for Chronic Conditions (PACIC)	12 months

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