Clinical trial NCT02407691: Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Depression
Chronic Diseases of Lifestyle
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: King's College London
name: University of KwaZulu
First posted: 2015-04-03
Enrollment: 2002
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Viral load suppression
timeFrame: 12 months
measure: Patient Health Questionnaire 9 (PHQ-9) response
timeFrame: 6 months
Secondary outcomes:
measure: PHQ-9 Response at 12 months
timeFrame: 12 months
measure: Depression Remission at 12 months
timeFrame: 12 months
measure: Mean PHQ-9 score at 6 and 12 months
timeFrame: 6 and 12 months
measure: Antiretroviral therapy programme retention
timeFrame: 12 months
measure: Viral load suppression at 12 months
timeFrame: 12 months
measure: Virological failure
timeFrame: 12 months
measure: Appropriate maintenance on enrollment ART regimen OR ART regimen switched to second-line
timeFrame: 12 months
measure: ART adherence
timeFrame: 12 months
measure: Change in viral load values over time
timeFrame: 12 months
measure: Depression severity (categorised as mild, moderate, moderately severe or severe depression at 6 and 12 months)
timeFrame: 6 and 12 months
measure: Antidepressant treatment initiated or intensified
timeFrame: 12 months
measure: Counselling for depression by a clinic-based counsellor
timeFrame: 12 months
measure: Referral to specialist mental health worker/service
timeFrame: 12 months
measure: Hospital admissions
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Stress
timeFrame: 12 months
measure: Stigma
timeFrame: 12 months
measure: Risk factors for cardiovascular diseases
timeFrame: 12 months
measure: Detection and treatment of other chronic diseases
timeFrame: 12 months
measure: Provision of integrated care from patient perspective
timeFrame: 12 months
Other outcomes:
measure: Disability
timeFrame: 12 months
measure: Care utilization and resource use
timeFrame: 12 months
measure: Productivity and economic measures
timeFrame: 12 months
Locations:
city: Klerksdorp
country: South Africa
facility: Dr Kenneth Kaunda District
state: North West
city: Rustenburg
country: South Africa
facility: Bojanala District
state: North West
Study officials:
affiliation: University of Cape Town, Cape Town, South Africa
name: Lara Fairall, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of KwaZulu-Natal, Durban, South Africa
name: Inge Pitersen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Graham Thornicroft, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.