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

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dc.contributor.authorFairall, Lara
dc.contributor.authorPetersen, Inge
dc.contributor.authorZani, Babalwa
dc.contributor.authorFolb, Naomi
dc.contributor.authorGeorgeu-Pepper, Daniella
dc.contributor.authorSelohilwe, One
dc.contributor.authorPetrus, Ruwayda
dc.contributor.authorMntambo, Ntokozo
dc.contributor.authorBhana, Arvin
dc.contributor.authorLombard, Carl
dc.contributor.authorBachmann, Max
dc.contributor.authorLund, Crick
dc.contributor.authorHanass-Hancock, Jill
dc.contributor.authorChisholm, Daniel
dc.contributor.authorMcCrone, Paul
dc.contributor.authorCarmona, Sergio
dc.contributor.authorGaziano, Thomas
dc.contributor.authorLevitt, Naomi
dc.contributor.authorKathree, Tasneem
dc.contributor.authorThornicroft, Graham
dc.date.accessioned2018-05-04T09:35:14Z
dc.date.available2018-05-04T09:35:14Z
dc.date.issued2018-03-22
dc.date.updated2018-04-09T15:13:12Z
dc.description.abstractBackground 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.
dc.identifier.apacitationFairall, L., Petersen, I., Zani, B., Folb, N., Georgeu-Pepper, D., Selohilwe, O., ... Thornicroft, G. (2018). 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. <i>Trials</i>, http://hdl.handle.net/11427/27934en_ZA
dc.identifier.chicagocitationFairall, Lara, Inge Petersen, Babalwa Zani, Naomi Folb, Daniella Georgeu-Pepper, One Selohilwe, Ruwayda Petrus, et al "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." <i>Trials</i> (2018) http://hdl.handle.net/11427/27934en_ZA
dc.identifier.citationFairall, L., Petersen, I., Zani, B., Folb, N., Georgeu-Pepper, D., Selohilwe, O., ... & Bachmann, M. (2018). 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, 19(1), 193.
dc.identifier.ris TY - Journal Article AU - Fairall, Lara AU - Petersen, Inge AU - Zani, Babalwa AU - Folb, Naomi AU - Georgeu-Pepper, Daniella AU - Selohilwe, One AU - Petrus, Ruwayda AU - Mntambo, Ntokozo AU - Bhana, Arvin AU - Lombard, Carl AU - Bachmann, Max AU - Lund, Crick AU - Hanass-Hancock, Jill AU - Chisholm, Daniel AU - McCrone, Paul AU - Carmona, Sergio AU - Gaziano, Thomas AU - Levitt, Naomi AU - Kathree, Tasneem AU - Thornicroft, Graham AB - 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. DA - 2018-03-22 DB - OpenUCT DO - 10.1186/s13063-018-2517-7 DP - University of Cape Town J1 - Trials LK - https://open.uct.ac.za PB - University of Cape Town PY - 2018 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/27934 ER - en_ZA
dc.identifier.urihttp://dx.doi.org/10.1186/s13063-018-2517-7
dc.identifier.urihttp://hdl.handle.net/11427/27934
dc.identifier.vancouvercitationFairall L, Petersen I, Zani B, Folb N, Georgeu-Pepper D, Selohilwe O, et al. 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; http://hdl.handle.net/11427/27934.en_ZA
dc.language.isoen
dc.publisherBioMed Central
dc.publisher.departmentDepartment of Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rights.holderThe Author(s).
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.sourceTrials
dc.source.urihttps://trialsjournal.biomedcentral.com/
dc.subject.otherAntiretroviral therapy
dc.subject.otherViral load
dc.subject.otherDepression
dc.subject.otherMental health gap
dc.subject.otherPrimary healthcare
dc.subject.otherPragmatic trials
dc.subject.otherLow- and middle-income countries
dc.subject.otherImplementation science
dc.titleCollaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial
dc.typeJournal Article
uct.type.filetypeText
uct.type.filetypeImage
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