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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 2002
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • North West
    • Klerksdorp, North West, South Africa
      • Dr Kenneth Kaunda District
    • Rustenburg, North West, South Africa, 0299
      • Bojanala District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary Care 101 Enhanced guideline; Primary Care 101 guideline with enhanced mental health	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.
Active Comparator: Standard of care; Primary Care 101 standard version guideline	Other: Standard Primary Care 101; Standard Primary Care 101 guideline with standard training

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	Measured by WHODAS 2	12 months
Care utilization and resource use	Measured by service use questionnaire	12 months
Productivity and economic measures	Self reported	12 months

Collaborators and Investigators

• Sponsor: University of Cape Town
• Collaborators: King's College London; University of KwaZulu
• Investigators: Principal Investigator: Lara Fairall, PhD, University of Cape Town, Cape Town, South Africa; Principal Investigator: Inge Pitersen, PhD, University of KwaZulu-Natal, Durban, South Africa; Principal Investigator: Graham Thornicroft, PhD, King's College London

Publications and helpful links

General Publications

• Fairall L, Petersen I, Zani B, Folb N, Georgeu-Pepper D, Selohilwe O, Petrus R, Mntambo N, Bhana A, Lombard C, Bachmann M, Lund C, Hanass-Hancock J, Chisholm D, McCrone P, Carmona S, Gaziano T, Levitt N, Kathree T, Thornicroft G; CobALT research team. Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial. Trials. 2018 Mar 22;19(1):193. doi: 10.1186/s13063-018-2517-7.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: March 19, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimated): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Disease Attributes; Depression; Depressive Disorder; Chronic Disease
• Other Study ID Numbers: 1R01MH100470-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No