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

University of Cape Town2,002 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

2,002

Conditions

HIV/AIDS Depression Chronic Diseases of Lifestyle

Interventions

Primary care 101 plus mental healthOTHER

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 101OTHER

Standard Primary Care 101 guideline with standard training

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Dr Kenneth Kaunda District

Klerksdorp, North West, South Africa

Bojanala District

Rustenburg, North West, South Africa

Outcomes

Primary Outcomes

Viral load suppression

viral load value of \<1000 RNA copies/ml

Time frame: 12 months

Patient Health Questionnaire 9 (PHQ-9) response

At least 50% improvement in PHQ-9 score compared with baseline

Time frame: 6 months

Secondary Outcomes

PHQ-9 Response at 12 months

At least 50% improvement in PHQ-9 score compared with baseline

Time frame: 12 months

Depression Remission at 12 months

Score of less than 5 in PHQ-9

Time frame: 12 months

Mean PHQ-9 score at 6 and 12 months

Average score in the PHQ-9

Time frame: 6 and 12 months

Antiretroviral therapy programme retention

continuation in the ART programme

Time frame: 12 months

Viral load suppression at 12 months

Defined as a viral load of \<400 copies/ml

Time frame: 12 months

Virological failure

Defined as two viral load values \>1000 copies/ml

Time frame: 12 months

Appropriate maintenance on enrollment ART regimen OR ART regimen switched to second-line

continuation with the ART regimen OR change

Time frame: 12 months

ART adherence

30 day VAS self reported measure

Time frame: 12 months

Change in viral load values over time

change in HIV RNA copies measured by PCR

Time frame: 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.

Time frame: 6 and 12 months

Antidepressant treatment initiated or intensified

start or intensification of anti-depressants after baseline

Time frame: 12 months

Counselling for depression by a clinic-based counsellor

Having counselling sessions with the clinic counsellor

Time frame: 12 months

Referral to specialist mental health worker/service

Referral by a nurse to mental health worker/service

Time frame: 12 months

Hospital admissions

number and duration of overnight hospital stays

Time frame: 12 months

Mortality

Mortality reported at loss to follow-up or through the South African Population register

Time frame: 12 months

Stress

Measured through the Percieved Stress Scale

Time frame: 12 months

Stigma

Measured through the 6-item AIDS related stigma scale

Time frame: 12 months

Risk factors for cardiovascular diseases

Measured by blood pressure, weight, smoking status

Time frame: 12 months

Detection and treatment of other chronic diseases

Identification of new cases of NCDs or risk factors of Chronic deseases

Time frame: 12 months

Provision of integrated care from patient perspective

Assessed using the Patient Assessment of Care for Chronic Conditions (PACIC)

Time frame: 12 months

Data from ClinicalTrials.gov

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