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

Abstract

BackgroundThe 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.MethodsThe 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.DiscussionThe 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 registrationClinicalTrials.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.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2517-7) contains supplementary material, which is available to authorized users.

Empowering frontline providers to deliver universal primary healthcare using the Practical Approach to care kit

“…Absolute effect sizes are in line with implementation science literature, and effects extend to health outcomes and economic benefits, including fewer and shorter hospital admissions 21 23. A further four trials involving almost 50 000 patients from 88 clinics are underway, with components evaluating mental health24 25 and non-communicable diseases,26 as well as preliminary work for a trial of PACK Child 27…”

“…PACK aims to contribute by starting with clear guidance on how best to manage the clinical aspects of a consultation, recognising that clinicians who fear missing a potentially fatal diagnosis or are uncertain about how to start assessing a particular complaint are in no position to provide person centred care. We have developed clinical communication skills focused on mental health in our training programmes24 25 and are raising awareness of the understanding that person centred care includes care of clinicians too.…”

Patient-level predictors of detection of depressive symptoms, referral, and uptake of depression counseling among chronic care patients in KwaZulu-Natal, South Africa

“…An integrated, collaborative approach to the management of depression and other CMDs was developed and evaluated in South Africa with the support of the Programme for Improving Mental Healthcare (PRIME) consortium [40]. The history and design of this model have been described in detail elsewhere (Fairall et al ., 2018 ; Petersen et al ., 2018 ). It was piloted and trialed in North West Province, and scaled to Amajuba District in KwaZulu-Natal with the support of the President's Emergency Plan For AIDS Relief (PEPFAR).…”

Empowering frontline providers to deliver universal primary healthcare using the Practical Approach to Care Kit

“… 19 20 21 22 Absolute effect sizes are in line with implementation science literature, and effects extend to health outcomes and economic benefits, including fewer and shorter hospital admissions. 21 23 A further four trials involving almost 50 000 patients from 88 clinics are underway, with components evaluating mental health 24 25 and non-communicable diseases, 26 as well as preliminary work for a trial of PACK Child. 27 …”

“…PACK aims to contribute by starting with clear guidance on how best to manage the clinical aspects of a consultation, recognising that clinicians who fear missing a potentially fatal diagnosis or are uncertain about how to start assessing a particular complaint are in no position to provide person centred care. We have developed clinical communication skills focused on mental health in our training programmes 24 25 and are raising awareness of the understanding that person centred care includes care of clinicians too.…”