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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Lara Fairall, Inge Petersen, Babalwa Zani, Naomi Folb, Daniella Georgeu-Pepper, One Selohilwe, Ruwayda Petrus, Ntokozo Mntambo, Arvin Bhana, Carl Lombard, Max Bachmann, Crick Lund, Jill Hanass-Hancock, Daniel Chisholm, Paul McCrone, Sergio Carmona, Thomas Gaziano, Naomi Levitt, Tasneem Kathree, Graham Thornicroft, the CobALT research team

Published in: Trials | Issue 1/2018

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Abstract

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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Metadata
Title
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
Authors
Lara Fairall
Inge Petersen
Babalwa Zani
Naomi Folb
Daniella Georgeu-Pepper
One Selohilwe
Ruwayda Petrus
Ntokozo Mntambo
Arvin Bhana
Carl Lombard
Max Bachmann
Crick Lund
Jill Hanass-Hancock
Daniel Chisholm
Paul McCrone
Sergio Carmona
Thomas Gaziano
Naomi Levitt
Tasneem Kathree
Graham Thornicroft
the CobALT research team
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2517-7

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