Collaborative implementation of an evidence-based package of integrated primary mental healthcare using quality improvement within a learning health systems approach: Lessons from the Mental health INTegration programme in South Africa.

Introduction: The treatment gap for mental health disorders persists in low- and middle-income countries despite overwhelming evidence of the efficacy of task-sharing mental health interventions. Key barriers in the uptake of these innovations include the absence of policy to support implementation and diverting of staff from usual routines in health systems that are already overstretched. South Africa enjoys a conducive policy environment; however, strategies for operationalizing the policy ideals are lacking. This paper describes the Mental health INTegration Programme (MhINT), which adopted a health system strengthening approach to embed an evidence-based task-sharing care package for depression to integrate mental health care into chronic care at primary health care (PHC). Methods: The MhINT care package consisting of psycho-education talks, nurse-led mental health assessment, and a structured psychosocial counselling intervention provided by lay counsellors was implemented in Amajuba district in KwaZulu-Natal over a 2-year period. A learning health systems approach was adopted, using continuous quality improvement (CQI) strategies to facilitate embedding of the intervention.MhINT was implemented along five phases: the project phase wherein teams to drive implementation were formed; the diagnostic phase where routinely collected data were used to identify system barriers to integrated mental health care; the intervention phase consisting of capacity building and using Plan-Do-Study-Act cycles to address implementation barriers and the impact and sustaining improvement phases entailed assessing the impact of the program and initiation of system-level interventions to sustain and institutionalize successful change ideas. Results: Integrated planning and monitoring were enabled by including key mental health service indicators in weekly meetings designed to track the performance of noncommunicable diseases and human immunovirus clinical programmes. Lack of standardization in mental health screening prompted the validation of a mental health screening tool and testing feasibility of its use in centralized screening stations. A culture of collaborative problem-solving was promoted through CQI data-driven learning sessions. The province-level screening rate increased by 10%, whilst the district screening rate increased by 7% and new patients initiated to mental health treatment increased by 16%. Conclusions: The CQI approach holds promise in facilitating the attainment of integrated mental health care in resource-scarce contexts. A collaborative relationship between researchers and health system stakeholders is an important strategy for facilitating the uptake of evidence-based innovations. However, the lack of interventions to address healthcare workers' own mental health poses a threat to integrated mental health care at PHC.

Prevalence estimates of tuberculosis infection in adults in Denmark: a retrospective nationwide register-based cross-sectional study, 2010 to 2018.

BackgroundTuberculosis (TB) elimination requires identifying and treating persons with TB infection (TBI).AimWe estimate the prevalence of positive interferon gamma release assay (IGRA) tests (including TB) and TBI (excluding TB) in Denmark based on TBI screening data from patients with inflammatory bowel disease (IBD) or inflammatory rheumatic disease (IRD).MethodsUsing nationwide Danish registries, we included all patients with IBD or IRD with an IGRA test performed between 2010 and 2018. We estimated the prevalence of TBI and positive IGRA with 95% confidence intervals (CI) in adolescents and adults aged 15-64 years after sample weighting adjusting for distortions in the sample from the background population of Denmark for sex, age group and TB incidence rates (IR) in country of birth.ResultsIn 13,574 patients with IBD or IRD, 12,892 IGRA tests (95.0%) were negative, 461 (3.4%) were positive and 221 (1.6%) were indeterminate, resulting in a weighted TBI prevalence of 3.2% (95% CI: 2.9-3.5) and weighted positive IGRA prevalence of 3.8% (95% CI: 3.5-4.2) among adults aged 15-64 years in the background population of Denmark. Unweighted TBI prevalence increased with age and birthplace in countries with a TB IR higher than 10/100,000 population.ConclusionEstimated TBI prevalence is low in Denmark. We estimate that 200,000 persons have TBI and thus are at risk of developing TB. Screening for TBI and preventive treatment, especially in persons born in high TB incidence countries or immunosuppressed, are crucial to reduce the risk of and eliminate TB.

Effect of Spironolactone on Kidney Function in Kidney Transplant Recipients: A Randomized Placebo-Controlled Clinical Trial.

BACKGROUND: Long-term kidney allograft survival is hampered by progressive interstitial fibrosis and tubular atrophy. The SPIREN trial tested the hypothesis that the mineralocorticoid receptor antagonist spironolactone stabilizes kidney function and attenuates glomerular barrier injury in kidney transplant patients treated with calcineurin inhibitors. METHODS: Randomized, placebo-controlled, double blind clinical trial including 188 prevalent kidney transplant patients. Patients were randomized to spironolactone or placebo for three years. Glomerular filtration rate was measured along with proteinuria and kidney fibrosis. The primary endpoint was change in measured glomerular filtration rate. Secondary outcomes were 24h proteinuria, kidney allograft fibrosis and cardiovascular events. Measured glomerular filtration rates, 24h proteinuria and blood pressure were determined yearly. Kidney biopsies were collected at baseline and after two years (n=48). Fibrosis was evaluated by quantitative stereology and classified according to Banff. RESULTS: The groups were comparable at baseline except for slightly older allografts in the spironolactone group. Spironolactone reduced measured glomerular filtration rates (up to -7.6 (95% CI -10.9;-4.3) ml/min compared to placebo) independently of time since transplantation and blood pressure with no impact on the kidney function curve over time and reduced 24h proteinuria after one year. There was no significant effect of spironolactone on the development of interstitial fibrosis. CONCLUSION: Spironolactone added to standard therapy for three years in kidney transplant patients did not improve kidney function, long-term proteinuria or interstitial fibrosis.

Humoral antibody response following mRNA vaccines against SARS-CoV-2 in solid organ transplant recipients; a status after a fifth and bivalent vaccine dose.

Background: In solid organ transplant (SOT) recipients, the humoral response following COVID-19 vaccination is reduced, as a result of their immunosuppressed treatment. In this study, we investigated antibody concentrations after booster vaccinations until the fifth dose, the latter by monovalent or bivalent BA1 or BA4/5 vaccines. In addition, we evaluated the efficacy of vaccination by recording breakthrough infections, hospitalizations, and deaths. Method: This prospective cohort study included 438 SOT recipients (>18 years) vaccinated with mRNA vaccines against COVID-19 from January 2021 until March 2023. Blood samples were drawn before and after each vaccination and tested for SARS-CoV-2 spike RBD IgG antibodies with the lowest and highest cut-off at 7.1 and 5,680 BAU/mL, respectively. Vaccine information, breakthrough infections, and hospitalizations were collected from the medical records. Results: Most participants received BNT162b2 and 61.4% received five vaccine doses. The response proportion in SOT recipients increased from 86.7% after the fourth dose to 93.0% following the fifth dose. Antibody concentration decreased with 142.7 BAU/mL between the third and fourth dose (median 132 days, Quartile 1: 123, Quartile 3: 148) and 234.3 BAU/mL between the fourth and fifth (median 250 days, Quartile 1: 241, Quartile 3: 262) dose among those without breakthrough infection (p=0.34). When comparing the Omicron BA.1 or Omicron BA.4/BA.5 adapted vaccines, no significant differences in antibody concentration were found, but 20.0% of SOT recipients receiving a monovalent fifth vaccine dose had a breakthrough infection compared to 4.0% and 7.9% among those who received BA.1 and BA.4/BA.5 adapted vaccines, respectively (p=0.04). Since January 2021, 240 (54.8%) participants had a breakthrough infection, and 22 were hospitalized, but no deaths were observed. Conclusions: The fifth COVID-19 vaccine dose raised antibody response to 93.0% of the study population. Additional booster doses, as well as bivalent vaccines, led to higher levels of antibody concentration in SOT recipients. We found a lower incidence of breakthrough infections among SOT recipients after receiving a bivalent vaccine as a fifth dose compared to those receiving a monovalent dose. Antibody concentrations did not wane when the time between doses was prolonged from four to eight months.

Strengthening integrated depression services within routine primary health care using the RE-AIM framework in South Africa.

Integration of mental health into routine primary health care (PHC) services in low-and middle-income countries is globally accepted to improve health outcomes of other conditions and narrow the mental health treatment gap. Yet implementation remains a challenge. The aim of this study was to identify implementation strategies that improve implementation outcomes of an evidence-based depression care collaborative implementation model integrated with routine PHC clinic services in South Africa. An iterative, quasi-experimental, observational implementation research design, incorporating the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, was applied to evaluate implementation outcomes of a strengthened package of implementation strategies (stage two) compared with an initial evaluation of the model (stage one). The first stage package was implemented and evaluated in 10 PHC clinics and the second stage strengthened package in 19 PHC clinics (inclusive of the initial 10 clinics) in one resource-scarce district in the province of KwaZulu-Natal, South Africa. Diagnosed service users were more likely to be referred for counselling treatment in the second stage compared with stage one (OR 23.15, SE = 18.03, z = 4.04, 95%CI [5.03-106.49], p < .001). Training in and use of a validated, mandated mental health screening tool, including on-site educational outreach and technical support visits, was an important promoter of nurse-level diagnosis rates (OR 3.75, 95% CI [1.19, 11.80], p = 0.02). Nurses who perceived the integrated care model as acceptable were also more likely to successfully diagnose patients (OR 2.57, 95% CI [1.03-6.40], p = 0.043). Consistent availability of a clinic counsellor was associated with a greater probability of referral (OR 5.9, 95%CI [1.29-27.75], p = 0.022). Treatment uptake among referred service users remained a concern across both stages, with inconsistent co-located counselling services associated with poor uptake. The importance of implementation research for strengthening implementation strategies along the cascade of care for integrating depression care within routine PHC services is highlighted.

Expanding mental health services in low- and middle-income countries: A task-shifting framework for delivery of comprehensive, collaborative, and community-based care.

This paper proposes a framework for comprehensive, collaborative, and community-based care (C4) for accessible mental health services in low-resource settings. Because mental health conditions have many causes, this framework includes social, public health, wellness and clinical services. It accommodates integration of stand-alone mental health programs with health and non-health community-based services. It addresses gaps in previous models including lack of community-based psychotherapeutic and social services, difficulty in addressing comorbidity of mental and physical conditions, and how workers interact with respect to referral and coordination of care. The framework is based on task-shifting of services to non-specialized workers. While the framework draws on the World Health Organization's Mental Health Gap Action Program and other global mental health models, there are important differences. The C4 Framework delineates types of workers based on their skills. Separate workers focus on: basic psychoeducation and information sharing; community-level, evidence-based psychotherapeutic counseling; and primary medical care and more advanced, specialized mental health services for more severe or complex cases. This paper is intended for individuals, organizations and governments interested in implementing mental health services. The primary aim is to provide a framework for the provision of widely accessible mental health care and services.

Missed Opportunities to Diagnose Common Variable Immunodeficiency: a Population-Based Case-Control Study Identifying Indicator Diseases for Common Variable Immunodeficiency.

PURPOSE: Delayed diagnosis of common variable immunodeficiency (CVID) remains a serious problem. We investigated whether some diseases diagnosed during out-patient visits or admission to hospitals could act as indicator conditions for CVID diagnosis. METHODS: In this nested case-control study, we identified 128 cases diagnosed with CVID in Denmark (1999-2013) and 640 age-, gender-, and region-matched controls. We obtained data on diseases diagnosed at hospitals in the five years before CVID diagnosis from The National Hospital Registry. We grouped hospital diagnoses in 33 major disease categories and 210 subcategories. We used conditional logistic regression to calculate the odds ratios (OR) and 95% confidence intervals (CI) to estimate associations between disease exposure and subsequent CVID. RESULTS: During the five years preceding a CVID diagnosis, cases had four times as many hospital contacts as the controls (p < 0.001). A diagnosis in 18 major disease categories showed a significant OR for subsequent diagnosis of CVID. The most substantial association with a subsequent CVID diagnosis was a diagnosis of lower respiratory tract infections (OR: 29.9; 95% CI: 14.2-63.2) and lung diseases (35.1; 15.0-82.5). We observed a similar association when we removed the last year before diagnosis from analysis and overall, in the years < 1, ≥ 1-3, and ≥ 3-5 before diagnosis, although the absolute number of exposures was small. Twenty-eight specific diseases displayed an at least 3-fold risk of subsequent CVID diagnosis. CONCLUSION: Targeted screening for antibody deficiency in patients diagnosed with specific diseases associated with CVID may lead to earlier CVID diagnosis and treatment and thereby potentially reduced morbidity and mortality.

Challenges and opportunities for implementation and dissemination of a task- sharing counselling intervention for depression at primary health care level in South Africa.

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.

Management of Depression in Chronic Care Patients Using a Task-Sharing Approach in a Real-World Primary Health Care Setting in South Africa: Outcomes of a Cohort Study.

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.

Peer-led recovery groups for people with psychosis in South Africa (PRIZE): protocol for a randomised controlled feasibility trial.

BACKGROUND: The available care for people with psychosis in South Africa is inadequate to support personal recovery. Group peer support interventions are a promising approach to foster recovery, but little is known about the preferences of service users, or the practical application of this care model, in low- and middle-income countries (LMIC). This study aims to assess the acceptability and feasibility of integrating peer-led recovery groups for people with psychosis and their caregivers in South Africa into existing systems of care, and to determine key parameters in preparation for a definitive trial. METHODS: The study is set in Nelson Mandela Bay Metropolitan district of the Eastern Cape Province, South Africa. The design is an individually randomised parallel group feasibility trial comparing recovery groups in addition to treatment as usual (TAU) with TAU alone in a 1:1 allocation ratio. We aim to recruit 100 isiXhosa-speaking people with psychosis and 100 linked caregivers. TAU comprises anti-psychotic medication-focused outpatient care. The intervention arm will comprise seven recovery groups, including service users and caregiver participants. Recovery groups will be delivered in two phases: a 2-month phase facilitated by an auxiliary social worker, then a 3-month peer-led phase. We will use mixed methods to evaluate the process and outcomes of the study. Intervention acceptability and feasibility (primary outcomes) will be assessed at 5 months post-intervention start using qualitative data collected from service users, caregivers, and auxiliary social workers, along with quantitative process indicators. Facilitator competence will be assessed with the GroupACT observational rating tool. Trial procedures will be assessed, including recruitment and retention rates, contamination, and validity of quantitative outcome measures. To explore potential effectiveness, quantitative outcome data (functioning, unmet needs, personal recovery, internalised stigma, health service use, medication adherence, and caregiver burden) will be collected at baseline, 2 months, and 5 months post-intervention start. DISCUSSION: This study will contribute to the sparse evidence on the acceptability and feasibility of peer-led and recovery-oriented interventions for people with psychosis in LMIC when integrated into existing care systems. Results from this feasibility trial will inform preparations for a definitive trial and subsequent larger-scale implementation. TRIAL REGISTRATION: Pan-African Clinical Trials Register PACTR202202482587686. Registered on 28 February 2022.  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=21496 .

A health systems intervention to strengthen the integration of tuberculosis and COVID-19 detection: Outcomes of a quasi-experimental study in a high burden tuberculosis district in KwaZulu Natal, South Africa.

OBJECTIVES: The adverse effects of the COVID-19 pandemic on tuberculosis (TB) detection have been well documented. Despite shared symptoms, guidance for integrated screening for TBand COVID-19 are limited, and opportunities for health systems strengthening curtailed by lockdowns. We partnered with a high TB burden district in KwaZulu-Natal, South Africa, to co-develop an integrated approach to assessing COVID-19 and TB, delivered using online learning and quality improvement, and evaluated its performance on TB testing and detection. METHODS: We conducted a mixed methods study incorporating a quasi-experimental design and process evaluation in 10 intervention and 18 control clinics. Nurses in all 28 clinics were all provided access to a four-session online course to integrate TB and COVID-19 screening and testing, which was augmented with some webinar and in-person support at the 10 intervention clinics. We estimated the effects of exposure to this additional support using interrupted time series Poisson regression mixed models. Process evaluation data comprised interviews before and after the intervention. Thematic coding was employed to provide explanations for effects of the intervention. RESULTS: Clinic-level support at intervention clinics was associated with a markedly higher uptake (177 nurses from 10 intervention clinics vs. 19 from 18 control clinics). Lack of familiarity with online learning, and a preference for group learning hindered the transition from face-to-face to online learning. Even so, any exposure to training was initially associated with higher rates of GeneXpert testing (adjusted incidence ratio [IRR] 1.11, 95% confidence interval 1.07-1.15) and higher positive TB diagnosis (IRR 1.38, 1.11-1.71). CONCLUSIONS: These results add to the knowledge base regarding the effectiveness of interventions to strengthen TB case detection during the COVID-19 pandemic. The findings support the feasibility of a shift to online learning approaches in low-resource settings with appropriate support and suggest that even low-intensity interventions are capable of activating nurses to integrate existing disease control priorities during pandemic conditions.

Introducing Cambridge Prisms: Global Mental Health.

With the launch of the Prisms Global Mental Health series, we are taking the opportunity to make explicit our vision for Global Mental Health. We strongly propose a Public Mental Health approach, incorporating culture and context and prioritizing equity and inclusion, particularly of previously marginalized groups. In using a Public Mental Health approach, we are framing Global Mental Health research as population-oriented research that seeks to understand the etiology, prevention, promotion, and treatment of mental and behavioral health problems with a strong emphasis on 'knowledge generation' which is relevant, transferable, and generalizable to different populations and settings. The public health approach also incorporates policy and systems research and evaluation, with a particular focus on accessibility and quality of care and human rights. By using the term Global, we are being explicit in acknowledging the role(s) of culture and context in all stages of research, from conceptualization through interpretation and dissemination. In centering equity and inclusion, we are advocating for a focus on populations who have been marginalized and have not been well represented within Global Mental Health research and active participation of voices of the populations that are included in the research. We are also working to promote participation of individuals from diverse and underrepresented communities and diverse experiences, including those with lived experience, in all stages of research pipeline: from conceptualization to publication of findings. Our readers will see these values and ideas operationalized in the choice of article topics and the published manuscripts as well as in the editorial and advisory board membership and selection of reviewers.

Mental health stigma experiences among caregivers and service users in South Africa: a qualitative investigation.

The study aimed to understand the nature and context of mental health stigma among people living with a mental health condition and the subsequent effect on their caregivers. Semi-structured qualitative face to face interviews were conducted by trained mental healthcare professionals with mental health service users (n = 26) and caregivers (n = 24) in private rooms at a tertiary health facility, where service users were admitted. Following transcription and translation, data was analysed using framework analysis. There was limited knowledge about their mental health diagnosis by service users and generally low mental health literacy among service users and caregivers. Mental health service users reported experiences of stigma from their own families and communities. Caregivers reported withholding the patient's diagnosis from the community for fear of being stigmatised, and this fear of stigma carries the risk of negatively affecting care treatment-seeking. Limited mental health knowledge, coupled with a high prevalence of perceived family and community stigma among caregivers and service users, impedes the capacity of caregivers to effectively cope in supporting their family members living with mental illness. There is a need for interventions to provide psychoeducation, reduce community stigma, and support coping strategies for caregivers and people with mental health conditions.

Vitamin K supplementation and bone mineral density in dialysis: results of the double-blind, randomized, placebo-controlled RenaKvit trial.

BACKGROUND: Vitamin K deficiency is highly prevalent in patients on dialysis and may contribute to their low bone mineral density (BMD) and increased risk of fracture. This study investigated the effect of menaquinone-7 (MK-7) supplementation on BMD in patients on chronic dialysis. METHODS: In a multicentre, double-blind, placebo-controlled intervention trial, 123 patients on chronic dialysis were randomised to a daily oral supplement of either MK-7 360 µg or placebo for 2 years. BMD of the distal radius (1/3, mid, ultradistal and total), femoral neck, lumbar spine (L1-L4) and whole body was assessed by dual-energy X-ray absorptiometry. Serum levels of vitamin K1 and MK-7 and plasma levels of total osteocalcin, dephosphorylated-uncarboxylated matrix Gla protein and protein induced by vitamin K absence II were measured to assess vitamin K status. RESULTS: After 2 years, an accelerated BMD loss of the 1/3 distal radius was found with MK-7 supplementation {mean difference of changes relative to placebo -0.023 g/cm2 [95% confidence interval (CI) -0.039 to -0.008]}, whereas the decrease in lumbar spine BMD seen in the placebo group was prevented [mean difference of changes between groups 0.050 g/cm2 (95% CI 0.015-0.085)]. No significant effects were observed at the remaining skeletal sites. Vitamin K status strongly improved in MK-7-supplemented participants. CONCLUSION: Compared with placebo, an accelerated BMD loss of the 1/3 distal radius was found after 2 years of MK-7 supplementation, whereas a decline in lumbar spine BMD was prevented. As such, MK-7 supplementation might modify BMD site-specifically in patients on dialysis. In aggregate, our findings do not support MK-7 supplementation to preserve bone in patients on dialysis.

Humoral immune response following a third SARS-CoV-2 mRNA vaccine dose in solid organ transplant recipients compared with matched controls.

Background: Solid organ transplant (SOT) recipients have shown suboptimal antibody response following COVID-19 vaccination. Several risk factors for the diminished response have been identified including immunosuppression and older age, but the influence of different comorbidities is not fully elucidated. Method: This case-control study consisted of 420 Danish adult SOT recipients and 840 sex- and age-matched controls, all vaccinated with a third homologous dose of either BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) vaccine. The primary outcome was differences in humoral immune response. The secondary outcome was breakthrough infections. Additionally, we looked for factors that could predict possible differences between the two groups. Results: Response rate increased from 186/382 (49%) to 275/358 (77%) in SOT recipients and remained on 781/790 (99%) to 601/609 (99%) in controls following a third vaccine dose. SOT recipients had significantly lower median antibody concentrations after third dose compared to controls (332.6 BAU/ml vs 46,470.0 BAU/ml, p <0.001). Lowest median antibody concentrations were seen in SOT recipients with liver disease (10.3 BAU/ml, IQR 7.1-319) and diabetes (275.3 BAU/ml, IQR 7.3-957.4). Breakthrough infections occurred similarly frequent, 150 (40%) among cases and 301 (39%) among controls (p = 0.80). Conclusion: A third COVID-19 vaccine dose resulted in a significant increase in humoral immunogenicity in SOT recipients and maintained high response rate in controls. Furthermore, SOT recipients were less likely to produce antibodies with overall lower antibody concentrations and humoral immunity was highly influenced by the presence of liver disease and diabetes. The prevalence of breakthrough infections was similar in the two groups.

A collaborative care package for depression comorbid with chronic physical conditions in South Africa.

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.

Applying learning health systems thinking in codeveloping integrated tuberculosis interventions in the contexts of COVID-19.

The COVID-19 pandemic reversed much of global progress made in combatting tuberculosis, with South Africa experiencing one of the largest impacts on tuberculosis detection. The aim of this paper is to share our experiences in applying learning health systems (LHS) thinking to the codevelopment of an intervention improving an integrated response to COVID-19 and tuberculosis in a South African district. A sequential partially mixed-methods study was undertaken between 2018 and 2021 in the district of Amajuba in KwaZulu-Natal. Here, we report on the formulation of a Theory of Change, codesigning and refining proposed interventions, and piloting and evaluating codesigned interventions in primary healthcare facilities, through an LHS lens. Following the establishment and formalisation of a district Learning Community, diagnostic work and a codevelopment of a theory of change, intervention packages tailored according to pandemic lockdowns were developed, piloted and scaled up. This process illustrates how a community of learning can generate more responsive, localised interventions, and suggests that the establishment of a shared space of research governance can provide a degree of resilience to facilitate adaption to external shocks. Four main lessons have been gleaned from our experience in adopting an LHS approach in a South African district, which are (1) the importance of building and sustaining relationships, (2) the utility of colearning, coproduction and adaptive capacity, (3) the centrality of theory-driven systems strengthening and (4) reflections on LHS as a framework.

Accuracy of a community mental health education and detection (CMED) tool for common mental disorders in KwaZulu-Natal, South Africa.

BACKGROUND: Screening tools for mental health disorders improve detection at a primary health care (PHC) level. However, many people with mental health conditions do not seek care because of a lack of knowledge about mental health, stigma about mental illness and a lack of awareness of mental health services available at a PHC facility level. Interventions at a community level that raise awareness about mental health and improve detection of mental health conditions, are thus important in increasing demand and optimising the supply of available mental health services. This study sought to evaluate the accuracy of a Community Mental Health Education and Detection (CMED) Tool in identifying mental health conditions using pictorial vignettes. METHODS: Community Health Workers (CHWs) administered the CMED tool to 198 participants on routine visits to households. Consenting family members provided basic biographical information prior to the administration of the tool. To determine the accuracy of the CMED in identifying individuals in households with possible mental health disorders, we compared the number of individuals identified using the CMED vignettes to the validated Brief Mental Health (BMH) screening tool. RESULTS: The CMED performed at an acceptable level with an area under the curve (AUC) of 0.73 (95% CI 0.67-0.79), identifying 79% (sensitivity) of participants as having a possible mental health problem and 67% (specificity) of participants as not having a mental health problem. Overall, the CMED positively identified 55.2% of household members relative to 49.5% on the BMH. CONCLUSION: The CMED is acceptable as a mental health screening tool for use by CHWs at a household level.

The Danish linguistic validation of the Ureteral Stent Symptoms Questionnaire.

INTRODUCTION: The aim of the study was to validate the Ureteral Stent Symptom Questionnaire (USSQ) in Danish for patients with indwelling ureteral stents. METHODS: The linguistic validation of the original USSQ was performed following standardised multi-step translation procedures. Seventy patients with indwelling ureteral stents were asked to complete the Danish USSQ one and two weeks after stent placement and four weeks after stent removal. RESULTS: A total of 65 patients (92.9%) completed the USSQ. Statistical evaluation revealed good internal consistency in all domains except work performance. Satisfactory convergent validity (less-than -0.4 or greater-than 0.4) was demonstrated for urinary symptoms, body pain and global quality of life. The test-retest reliability-coefficient was statistically significant for urinary symptoms, general health, pain and sexual matters. Inter-domain associations were positive and monotone for all subscales. All sub-scores, except sexual matters, significantly decreased from one week after stent insertion to four weeks after stent removal (p less-than 0.001). CONCLUSION: The Danish USSQ is a reliable and valid instrument with which to evaluate urinary symptoms and general health in patients with indwelling ureteral stents. FUNDING: Ideforum, Vejle Hospital, University Hospital of Southern Denmark, granted 80,000 DKK to support this work. TRIAL REGISTRATION: The Danish National Ethics Committee and Region Syddanmark approved the study (Study approval number 20192000-168 and journal number 19-52219, respectively).