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
Open accessAbstract
BACKGROUND: The scale-up of antiretroviral treatment (ART) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis, non-communicable diseases (NCDs) and mental health disorders. Depression is one such disorder that is associated with higher rates of non-adherence, progression to AIDS and greater mortality. Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90% of those on ART and is in line with the recent 90-90-90 Joint United Nations Programme on HIV/AIDS (UNAIDS) targets. The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART. METHODS: The study design is a pragmatic, parallel group, stratified, cluster randomised trial in 40 clinics across two rural districts of the North West Province of South Africa. The unit of randomisation is the clinic, with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Questionnaire (PHQ-9). Control group clinics are implementing the South African Department of Health's Integrated Clinical Services Management model, which aims to reduce fragmentation of care in the context of rising multimorbidity, and which includes training in the Primary Care 101 (PC101) guide covering communicable diseases, NCDs, women's health and mental disorders. In intervention clinics, we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care. We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling (eight sessions, individual or group), as well as adherence counselling sessions (one session, individual). The co-primary patient outcomes are a reduction in PHQ-9 scores of at least 50% from baseline and viral load suppression rates measured at 6 and 12 months, respectively. DISCUSSION: The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in resource-constrained settings. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02407691 ) registered on 19 March 2015; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015; South African National Clinical Trials Register (SANCTR) ( DOH-27-0515-5048 ) NHREC number 4048 issued on 21/04/2015.
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Integrated care may mean supporting staff in primary health care clinics to gain clinical skills and confidence to treat mental illnesses, as in North West Province South Africa within the COBALT and PRIME trials.
“Conversely, integrated care may mean supporting staff in primary health care clinics to gain the clinical skills and confidence to treat mental illnesses among the clinical cases treated, such as in clinics in the North West Province of South Africa within the COBALT and PRIME trials 80,81 (see Figure 3).”
From Integrated care for people with long-term mental and physical health conditions in low-income and middle-income countries (2019) · cites this paper as [81]
Evidence for integrated care is scarce in LMICs, especially for co-/multi-morbidities that include a mental disorder.
“Nevertheless, evidence for integrated care is still scarce in LMICs, and particularly so for co-/multi-morbidities that include a mental disorder 80,81 .”
From Integrated care for people with long-term mental and physical health conditions in low-income and middle-income countries (2019) · cites this paper as [81]
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- Authors
- the CobALT research team, 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.
- Affiliations
- University of Cape Town (ZA)
- University of KwaZulu-Natal (ZA)
- South African Medical Research Council (ZA)
- University of East Anglia (GB)
- World Health Organization Regional Office for Europe (DK)
- King's College London (GB)
- National Health Laboratory Service (ZA)
- Brigham and Women's Hospital (US)
- Corresponding author
- Fairall, Lara
- ORCID
- Venue
- Trials
- Published
- 2018-03-22
- Volume
- 19
- Issue
- 1
- Pages
- 193-193
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC5863840
- OpenAlex
- W2800766663
- Cited by
- 53
- References
- 81
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 7 · 2023: 7 · 2022: 8 · 2021: 11 · 2020: 7 · 2019: 4 · 2018: 3
- FWCI
- 4.71
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Portal (King's College London) (publishedVersion, cc-by)
- UEA Digital Repository (University of East Anglia) (acceptedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Open University of Cape Town (University of Cape Town) (submittedVersion, cc-by)
- Funders
- National Institute of Mental Health (5R01MH100470-03)
- Department for International Development (HRPC10)
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- collaborative care, depression, HIV, antiretroviral therapy, depression screening, PHQ-9, nurse-led care, adherence counseling, viral suppression, treatment gap, psychiatric comorbidity, resource-limited settings, South Africa, North West Province, rural clinics, cost-effectiveness, 90-90-90 targets
- MeSH terms
- Intersectoral Collaboration, Adult, Data Collection, Data Interpretation, Statistical, Depression, Humans, Referral and Consultation, Multicenter Studies as Topic, HIV Infections, Process Assessment, Health Care, Sample Size, Anti-Retroviral Agents, Pragmatic Clinical Trials as Topic
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