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Background. Integration of depression treatment into primary care could improve patient outcomes in low-resource settings. Losses along the depression care cascade limit integrated service effectiveness. This study identified patient-level factors that predicted detection of depressive symptoms by nurses, referral for depression treatment, and uptake of counseling, as part of integrated care in KwaZulu-Natal, South Africa. Methods. This was an analysis of baseline data from a prospective cohort. Participants were adult patients with at least moderate depressive symptoms at primary care facilities in Amajuba, KwaZulu-Natal, South Africa. Participants were screened for depressive symptoms prior to routine assessment by a nurse. Generalized linear mixed-effects models were used to estimate associations between patient characteristics and service delivery outcomes. Results. Data from 412 participants were analyzed. Nurses successfully detected depressive symptoms in 208 [50.5%, 95% confidence interval (CI) 38.9-62.0] participants; of these, they referred 76 (36.5%, 95% CI 20.3-56.5) for depression treatment; of these, 18 (23.7%, 95% CI 10.7-44.6) attended at least one session of depression counseling. Depressive symptom severity, alcohol use severity, and perceived stress were associated with detection. Similar factors did not drive referral or counseling uptake. Conclusions. Nurses detected patients with depressive symptoms at rates comparable to primary care providers in high-resource settings, though gaps in referral and uptake persist. Nurses were more likely to detect symptoms among patients in more severe mental distress. Implementation strategies for integrated mental health care in low-resource settings should target improved rates of detection, referral, and uptake. [ABSTRACT FROM AUTHOR]

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]

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: 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]

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]

Background: Community health workers (CHWs) play key roles in delivering health programmes in many countries worldwide. CHW programmes can improve coverage of maternal and child health services for the most disadvantaged and remote communities, leading to substantial benefits for mothers and children. However, there is limited evidence of effective mentoring and supervision approaches for CHWs.Methods: This is a cluster randomised controlled trial to investigate the effectiveness of a continuous quality improvement (CQI) intervention amongst CHWs providing home-based education and support to pregnant women and mothers. Thirty CHW supervisors were randomly allocated to intervention (n = 15) and control (n = 15) arms. Four CHWs were randomly selected from those routinely supported by each supervisor (n = 60 per arm). In the intervention arm, these four CHWs and their supervisor formed a quality improvement team. Intervention CHWs received a 2-week training in WHO Community Case Management followed by CQI mentoring for 12 months (preceded by 3 months lead-in to establish QI processes). Baseline and follow-up surveys were conducted with mothers of infants <12 months old living in households served by participating CHWs.Results: Interviews were conducted with 736 and 606 mothers at baseline and follow-up respectively; socio-demographic characteristics were similar in both study arms and at each time point. At follow-up, compared to mothers served by control CHWs, mothers served by intervention CHWs were more likely to have received a CHW visit during pregnancy (75.7 vs 29.0%, p < 0.0001) and the postnatal period (72.6 vs 30.3%, p < 0.0001). Intervention mothers had higher maternal and child health knowledge scores (49 vs 43%, p = 0.02) and reported higher exclusive breastfeeding rates to 6 weeks (76.7 vs 65.1%, p = 0.02). HIV-positive mothers served by intervention CHWs were more likely to have disclosed their HIV status to the CHW (78.7 vs 50.0%, p = 0.007). Uptake of facility-based interventions were not significantly different.Conclusions: Improved training and CQI-based mentoring of CHWs can improve quantity and quality of CHW-mother interactions at household level, leading to improvements in mothers' knowledge and infant feeding practices.Trial Registration: ClinicalTrials.Gov NCT01774136. [ABSTRACT FROM AUTHOR]

Background: Mental, neurological and substance use disorders contribute to a significant proportion of the world's disease burden, including in low and middle income countries (LMICs). In this study, we focused on the health systems required to support integration of mental health into primary health care (PHC) in Ethiopia, India, Nepal, Nigeria, South Africa and Uganda. Methods: A checklist guided by the World Health Organization Assessment Instrument for Mental Health Systems (WHO-AIMS) was developed and was used for data collection in each of the six countries participating in the Emerging mental health systems in low and middle-income countries (Emerald) research consortium. The documents reviewed were from the following domains: mental health legislation, health policies/plans and relevant country health programs. Data were analyzed using thematic content analysis. Results: Three of the study countries (Ethiopia, Nepal, Nigeria, and Uganda) were working towards developing mental health legislation. South Africa and India were ahead of other countries, having enacted recent Mental Health Care Act in 2004 and 2016, respectively. Among all the 6 study countries, only Nepal, Nigeria and South Africa had a standalone mental health policy. However, other countries had related health policies where mental health was mentioned. The lack of fully fledged policies is likely to limit opportunities for resource mobilization for the mental health sector and efforts to integrate mental health into PHC. Most countries were found to be allocating inadequate budgets from the health budget for mental health, with South Africa (5%) and Nepal (0.17%) were the countries with the highest and lowest proportions of health budgets spent on mental health, respectively. Other vital resources that support integration such as human resources and health facilities for mental health services were found to be in adequate in all the study countries. Monitoring and evaluation systems to support the integration of mental health into PHC in all the study countries were also inadequate. Conclusion: Integration of mental health into PHC will require addressing the resource limitations that have been identified in this study. There is a need for up to date mental health legislation and policies to engender commitment in allocating resources to mental health services. [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]