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Depressive symptoms are common in South African primary care patients with chronic medical conditions, but are usually unrecognised and untreated. This study evaluated an integrated, task-sharing collaborative approach to management of depression comorbid with chronic diseases in primary health care (PHC) patients in a real-world setting. Existing HIV clinic counsellors provided a manualised depression counselling intervention with stepped-up referral pathways to PHC doctors for initiation of anti-depressant medication and/ or referral to specialist mental health services. Using a comparative group cohort design, adult PHC patients in 10 PHC facilities were screened with the Patient Health Questionnaire-9 with those scoring above the validated cut-off enrolled. PHC nurses independently assessed, diagnosed and referred patients. Referral for treatment was independently associated with substantial improvements in depression symptoms three months later. The study confirms the viability of task-shared stepped-up collaborative care for depression treatment using co-located counselling in underserved real-world PHC settings. [ABSTRACT FROM AUTHOR]

Background: The treatment gap for mental health services is a growing public health concern. A lay-counselling service located at primary health care (PHC) level could potentially help to close the large treatment gap for common mental disorders in South Africa. The aim of this study was to understand multilevel factors contributing to implementation and potential dissemination of such a service for depression at PHC level. Methods: Process qualitative data of the lay-counselling service for patients with depressive symptoms was collected alongside a pragmatic randomized controlled trial evaluating a collaborative care model that included a lay-counselling service for patients with depressive symptoms. Semi-structured key informant interviews (SSI) were conducted with a purposive sample of PHC providers (lay-counsellors, nurse practitioners, operational managers), lay-counsellor supervisors, district and provincial managers, and patients in receipt of services. A total of 86 interviews were conducted. The Consolidated Framework for Implementation Research (CFIR) was used to guide data collection as well as Framework Analysis to determine barriers and facilitators for implementation and dissemination of the lay-counselling service. Results: Facilitators identified include supervision and support available for counsellors; person focused counselling approach; organizational integration of the counsellor within facilities. Barriers included lack of organizational support of the counselling service, including lack of counselling dedicated space; high counsellor turnover, resulting in a counsellor not available all the time; lack of an identified cadre to deliver the intervention in the system; and treatment of mental health conditions including counselling not included within mental health indicators. Conclusions: Several system level issues need to be addressed to promote integration and dissemination of lay-counselling services within PHC facilities in South Africa. Key system requirements are facility organizational readiness for improvement of integration of lay-counselling services; formal recognition of counselling services provided by lay counsellors as well as inclusion of lay counselling as a treatment modality within mental health treatment data element definitions and the need for diversification of the roles of psychologists to include training and supervision of lay counsellors was also emphasized. [ABSTRACT FROM AUTHOR]

Integrating mental health services into primary healthcare platforms is an established health systems strategy in low-to-middle-income countries. In South Africa, this was pursued through the Programme for Improving Mental Health Care (PRIME), a multi-country initiative that relied on task-sharing as a principle implementation strategy. Towards better describing the implementation processes, qualitative comparative analysis was adopted to explore causal pathways in the intervention. This study aimed to explore factors that could have influenced key outcomes of an integrated mental healthcare intervention in South Africa. Drawing from an embedded multiple case study design, the analysis used qualitative comparative analysis. Focusing on nine PHC clinics in the Dr Kenneth Kaunda District as cases, with depression reduction scores set as outcome measures, trial data variables were modelled in a hypothetical causal process. A fuzzy-set qualitative comparative analysis was performed by 1) developing the research questions, 2) developing the fuzzy set, 3) testing necessity and 4) testing sufficiency. These steps were undertaken collaboratively among the research team. The data were calibrated during several meetings among team members to gain a degree of consensus. Necessity analyses suggested that none of the causal conditions exceeded the threshold of necessity and triviality, and confirmed the inclusion of relevant variables in line with the proposed models. Sufficiency analyses produced two configurations, which were subjected to standard and specific analyses. Ultimately, the results suggested that none of the causal conditions were necessary for a reduction in depression scores to occur, while programme fidelity was identified as a sufficient condition for a reduction in scores to occur. The study highlights the importance of understanding implementation pathways to enable better integration of mental health services within primary healthcare in low-to-middle-income settings. It underlines the importance of programme fidelity in achieving the goals of implementation. [ABSTRACT FROM AUTHOR]

Background: The high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA).Methods/design: The study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months.Discussion: This trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa.Trial Registration: South African National Clinical Trial Register: SANCTR ( http://www.sanctr.gov.za/SAClinicalTrials ) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov : ID: NCT02425124 . Registered on 22 April 2015. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction: A task-sharing collaborative care model for integrated depression care for South Africa's burgeoning primary health care population with chronic conditions was developed and tested through two pragmatic cluster randomized controlled trials. One trial focused on patients with hypertension and was located in one district where a collaborative care model was co-designed with district stakeholders. The other trial, focused on patients on antiretroviral treatment, was located in the same district site, with the addition of a second neighbouring district, without adaptation of the original model. This paper describes the package used to implement this model, and implementation outcomes across the two sites, and summarises lessons and challenges.Methods: The Template for Intervention Description and Replication (TIDieR) framework, adapted for complex health systems interventions, was used to describe components of the package. Additional elements of 'modifications made' and 'actual implementation' introduced in the 'Getting messier with TIDieR' framework, were used to describe implementation outcomes in terms of reach, adoption and implementation across the two trial districts.Results: In the absence of a co-design process to adapt the model to the context of the second site, there was less system level support for the model. Consequently, more project employed human resources were deployed to support training of primary care nurses in identification and referral of patients with depression; and supervise co-located lay counsellors. Referrals to co-located lay counselling services were more than double in the second site. However, uptake of counselling sessions was greater in the first site. This was attributed to greater in-vivo supervision and support from existing mental health specialists in the system. There was greater reliance on online supervision and support in the second site where geographical distances between clinics were larger.Conclusion: The need for in-country co-designed collaborative care models, and 'implementation heavy' implementation research to understand adaptations required to accommodate varying in-country health system contexts is highlighted. [ABSTRACT FROM AUTHOR]

Background: In South Africa, the escalating prevalence of chronic illness and its high comorbidity with mental disorders bring to the fore the need for integrating mental health into chronic care at district level.Aims: To develop a district mental healthcare plan (MHCP) in South Africa that integrates mental healthcare for depression, alcohol use disorders and schizophrenia into chronic care.Method: Mixed methods using a situation analysis, qualitative key informant interviews, theory of change workshops and piloting of the plan in one health facility informed the development of the MHCP.Results: Collaborative care packages for the three conditions were developed to enable integration at the organisational, facility and community levels, supported by a human resource mix and implementation tools. Potential barriers to the feasibility of implementation at scale were identified.Conclusions: The plan leverages resources and systems availed by the emerging chronic care service delivery platform for the integration of mental health. This strengthens the potential for future scale up. [ABSTRACT FROM AUTHOR]

Background: We tested the real-world effectiveness of a collaborative task-sharing model on depressive symptom reduction in hypertensive Primary Health Care (PHC) patients in South Africa.Method: A pragmatic parallel cluster randomised trial in 20 clinics in the Dr Kenneth Kaunda district, North West province. PHC clinics were stratified by sub-district and randomised in a 1:1 ratio. Control clinics received care as usual (CAU), involving referral to PHC doctors and/or mental health specialists. Intervention clinics received CAU plus enhanced mental health training and a lay counselling referral service. Participant inclusion criteria were ≥ 18 years old, Patient Health Questionnaire-9 (PHQ-9) score ≥ 9 and receiving hypertension medication. Primary superiority outcome was ≥ 50% reduction in PHQ-9 score at 6 months. Statistical analyses comprised mixed effects regression models and a non-inferiority analysis.Trial Registration Number: NCT02425124.Results: Between April 2015 and October 2015, 1043 participants were enrolled (504 intervention and 539 control); 82% were women; half were ≥ 55 years. At 6 and 12 months follow-up, 91% and 89% of participants were interviewed respectively. One control group participant committed suicide. There was no significant difference in the primary outcome between intervention (N=256/456) and control (N=232/492) groups (55.9% versus 50.9%; adjusted risk difference = -0.04 ([95% CI = -0.19; 0.11], p = 0.6). The difference in PHQ-9 scores was within the defined equivalence limits at 6 and 12 months for the non-inferiority analysis.Limitations: The trial was limited by low exposure to depression treatment by trial participants and by observed co-intervention in control clinics CONCLUSIONS: Incorporating lay counselling services within collaborative care models does not produce superior nor inferior outcomes to models with specialist only counselling services.Funding: This work was supported by the UK Department for International Development [201446] as well as the National Institute of Mental Health, United States of America, grant number 1R01MH100470-01. Graham Thornicroft is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) South London at King's College London and King's College Hospital NHS Foundation Trust. [ABSTRACT FROM AUTHOR]