Comparing dedicated and designated approaches to integrating task-shared psychological interventions into chronic disease care in South Africa: a three-arm, cluster randomised, multicentre, open-label trial.

BACKGROUND: Community health workers (CHWs) are increasingly providing task-shared psychological interventions for depression and alcohol use in primary health care in low-income and middle-income countries. We aimed to compare the effectiveness of CHWs dedicated to deliver care with CHWs designated to deliver care over and above their existing responsibilities and with treatment as usual for patients with a chronic physical disease. METHODS: We did a three-arm, cluster randomised, multicentre, open-label trial done in 24 primary health-care clinics (clusters) within the Western Cape province of South Africa. Clinics were randomly assigned (1:1:1) to implement dedicated care, designated care, or treatment as usual, stratified by urban-rural status. Patients with HIV or type 1 or type 2 diabetes were eligible if they were 18 years old or older, taking antiretroviral therapy for HIV or medication to manage their diabetes, had an Alcohol Use Disorders Identification Test (AUDIT) score of eight or more or a Center for Epidemiologic Studies Depression Scale score of 16 or more, and were not receiving mental health treatment. In the intervention arms, all participants were offered three sessions of an evidence-based psychological intervention, based on motivational interviewing and problem-solving therapy, delivered by CHWs. Our primary outcomes were depression symptom severity and alcohol use severity, which we assessed separately for the intention-to-treat populations of people with HIV and people with diabetes cohorts and in a pooled cohort, at 12 months after enrolment. The Benjamini-Hochberg procedure was used to adjust for multiple testing. The trial was prospectively registered with the Pan African Clinical Trials Registry, PACTR201610001825403. FINDINGS: Between May 1, 2017, and March 31, 2019, 1340 participants were recruited: 457 (34·1%) assigned to the dedicated group, 438 (32·7%) assigned to the designated group, and 445 (33·2%) assigned to the treatment as usual group. 1174 (87·6%) participants completed the 12 month assessment. Compared with treatment as usual, the dedicated group (people with HIV adjusted mean difference -5·02 [95% CI -7·51 to -2·54], p<0·0001; people with diabetes -4·20 [-6·68 to -1·72], p<0·0001) and designated group (people with HIV -6·38 [-8·89 to -3·88], p<0·0001; people with diabetes -4·80 [-7·21 to -2·39], p<0·0001) showed greater improvement on depression scores at 12 months. By contrast, reductions in AUDIT scores were similar across study groups, with no intervention effects noted. INTERPRETATION: The dedicated and designated approaches to delivering CHW-led psychological interventions were equally effective for reducing depression, but enhancements are required to support alcohol reduction. This trial extends evidence for CHW-delivered psychological interventions, offering insights into how different delivery approaches affect patient outcomes. FUNDING: British Medical Research Council, Wellcome Trust, UK Department for International Development, the Economic and Social Research Council, and the Global Challenges Research Fund.

Women of Worth: the impact of a cash plus intervention to enhance attendance and reduce sexual health risks for young women in Cape Town, South Africa.

INTRODUCTION: Conditional cash transfers (CTs) augmented with other interventions are promising interventions for reducing HIV risk in adolescent girls and young women. METHODS: A multi-phase, quasi-experimental study assessed the impact of a CT (ZAR300; $22) conditional on attending a skills building intervention, Women of Worth (WoW), designed to improve sexual and reproductive health (SRH) outcomes in Cape Town, South Africa from May 2017 to December 2019. The intervention entailed 12 sessions with encouragement to attend adolescent and youth-friendly health services. Women aged 19-24 years were randomized 1:1 to receive the intervention with a CT ("cash + care" or C+C) or without a CT ("care"). The study included a pilot phase followed by a post-modification phase with improved uptake and retention without changing programme content or CT. Self-reported HIV prevalence and SRH/HIV vulnerability were assessed via a self-administered questionnaire at baseline, after 11 sessions, and 6-30 months' post-intervention for a subset. Mixed effect logistic regression models were fitted to estimate within-subject changes in outcomes. RESULTS: Of 5116 participants, 904 (452 participants per arm) were in the pilot and 4212 (2039 "care" participants and 2173 "C+C" participants) were in the post modified phase. There were 1867 (85.9%) and 135 (6,6%) participants in the "C+C" group and the "Care," respectively, that were WoW completers (≥ 11 sessions/retention). During the pilot phase, 194 (42.9%) and 18 (4.0%) participants in "C+C" and the "care" groups were retained. Receiving a CT sustained participation nearly 60-fold (OR 60.37; 95% CI: 17.32; 210.50, p <0.001). Three-hundred and thirty women were followed for a median of 15.0 months [IQR: 13.3; 17.8] to assess the durability of impact. Self-reported new employment status increased more than three-fold (p <0.001) at WoW completion and was sustained to the longer time point. Intimate partner violence indicators were reduced immediately after WoW, but this was not durable. CONCLUSIONS: Participants receiving CT had sustained participation in an SRH/HIV prevention skills building with improvement in employment and some SRH outcomes. Layered, "young woman centred" programmes to address HIV and SRH risk in young women may be enhanced with CT.

Patient outcomes and experience of a task-shared screening and brief intervention service for problem substance use in South African emergency centres: a mixed methods study.

BACKGROUND: Screening, brief intervention and referral to treatment (SBIRT) programmes have resulted in generally positive outcomes in healthcare settings, particularly for problem alcohol use, yet implementation is hampered by barriers such as concerns regarding the burden on healthcare professionals. In low-resourced settings, task-sharing approaches can reduce this burden by using non-professional healthcare workers, yet data are scarce regarding the outcomes and acceptability to patients within a SBIRT service. This study aims to evaluate patient-reported outcomes, patient acceptability, perceived benefits and recommendations for improving a task-shared SBIRT service in South African emergency centres (ECs). METHODS: This mixed methods study incorporates quantitative substance use screening and patient satisfaction data collected routinely within the service at three hospitals, and qualitative semi-structured interviews with 18 EC patient beneficiaries of the programme exploring acceptability and perceived benefits of the programme, as well as recommendations to improve the service. Approximately three months after the acute EC visit, a sub-sample of patients were followed up telephonically to assess patient-reported satisfaction and substance use outcomes. RESULTS: Of the 4847 patients eligible for the brief intervention, 3707 patients (76%) used alcohol as their primary substance and 794 (16%) used cannabis. At follow-up (n = 273), significant reductions in substance use frequency and severity were noted and over 95% of patients were satisfied with the service. In the semi-structured interviews, participants identified the non-judgemental caring approach of the counsellors, and the screening and psychoeducation components of the intervention as being the most valuable, motivating them to decrease substance use and make other positive lifestyle changes. Study participants made recommendations to include group sessions, market the programme in communities and extend the programme's reach to include a broader age group and a variety of settings. CONCLUSIONS: This task-shared SBIRT service was found to be acceptable to patients, who reported several benefits of a single SBIRT contact session delivered during an acute EC visit. These findings add to the SBIRT literature by highlighting the role of non-professional healthcare workers in delivering a low-intensity SBIRT service feasible to implement in low-resourced settings.

Integration of mental health counselling into chronic disease services at the primary health care level: Formative research on dedicated versus designated strategies in the Western Cape, South Africa.

OBJECTIVE: To explore health care providers' views on the acceptability and feasibility of two models for integrating facility-based counsellor delivered mental health counselling into chronic disease care, and how such an approach could be improved in South Africa. METHODS: Fourteen focus group discussions and 25 in-depth individual interviews were conducted with 109 health care workers and facility managers from 24 primary health clinics in the Western Cape, South Africa. RESULTS: Findings suggested that despite recent efforts to integrate mental health counselling into chronic disease services for common mental disorders, there remains limited availability of psychosocial and psychological counselling. Feedback on the two models of integration suggested equipoise and the potential of a hybrid approach where these approaches may be tailored to the specific needs and available resources of each facility. Participants identified constraints within the health system and broader social context that require consideration for integrating mental health counselling into chronic disease care. CONCLUSION: Although study participants unanimously agreed that counselling for common mental disorders should be integrated into chronic disease services, they had differing views on the type of model that should be adopted. There is a need for further testing of the two models and aspects of the health service that may require strengthening to implement any such model.

A task-sharing intervention for prepartum common mental disorders: Feasibility, acceptability and responses in a South African sample.

BACKGROUND: Peripartum common mental disorders (CMD) are highly prevalent in low- and middle-income countries (LMIC) such as South Africa. With limited public mental health resources, task sharing approaches to treatment are showing promise. However, little is known about the feasibility and acceptability of, as well as responses associated with problem-solving therapy (PST) for the treatment of prepartum CMD symptoms in South African public health settings. AIM: To investigate participants' preliminary responses to a task sharing PST intervention, and to evaluate the feasibility and acceptability of the intervention. SETTING: A Midwife and Obstetrics Unit attached to a Community Health Centre in a Western Cape district. METHODS: Using mixed methods, 38 participants' responses to a PST intervention, and their perceptions of its feasibility and acceptability, were explored. Primary outcomes included psychological distress (Self Reporting Questionnaire; SRQ-20) and depression symptoms (Edinborough Postnatal Depression Scale; EPDS). Semi-structured interviews were conducted three after the last session. Six stakeholders were also interviewed. RESULTS: Significant reductions were seen on EPDS (Cohen's d = 0.61; Hedges g = 0.60) and SRQ-20 (Cohen's d = 0.68; Hedges g = 0.67) scores. The intervention's acceptability lay in the opportunity for confidential disclosure of problems; and in relieving staff of the burden of managing of patients' distress. Barriers included lack of transport and work commitments. CONCLUSION: Results support task sharing PST to Registered Counsellors to treat antenatal CMDs in perinatal primary health care settings. Research is needed on how such programmes might be integrated into public health settings, incorporating other non-specialists.

A task-sharing intervention for prepartum common mental disorders: Feasibility, acceptability and responses in a South African sample

Background: Peripartum common mental disorders (CMD) are highly prevalent in low- and middle-income countries (LMIC) such as South Africa. With limited public mental health resources, task sharing approaches to treatment are showing promise. However, little is known about the feasibility and acceptability of, as well as responses associated with problem-solving therapy (PST) for the treatment of prepartum CMD symptoms in South African public health settings. Aim: To investigate participants' preliminary responses to a task sharing PST intervention, and to evaluate the feasibility and acceptability of the intervention. Setting: A Midwife and Obstetrics Unit attached to a Community Health Centre in a Western Cape district. Methods: Using mixed methods, 38 participants' responses to a PST intervention, and their perceptions of its feasibility and acceptability, were explored. Primary outcomes included psychological distress (Self Reporting Questionnaire; SRQ-20) and depression symptoms (Edinborough Postnatal Depression Scale; EPDS). Semi-structured interviews were conducted three after the last session. Six stakeholders were also interviewed. Results: Significant reductions were seen on EPDS (Cohen's d = 0.61; Hedges g = 0.60) and SRQ-20 (Cohen's d = 0.68; Hedges g = 0.67) scores. The intervention's acceptability lay in the opportunity for confidential disclosure of problems; and in relieving staff of the burden of managing of patients' distress. Barriers included lack of transport and work commitments. Conclusion: Results support task sharing PST to Registered Counsellors to treat antenatal CMDs in perinatal primary health care settings. Research is needed on how such programmes might be integrated into public health settings, incorporating other non-specialists

Implementation of a screening, brief intervention and referral to treatment programme for risky substance use in South African emergency centres: A mixed methods evaluation study.

BACKGROUND: Screening, brief intervention, and referral to treatment (SBIRT) for risky substance use is infrequently included in routine healthcare in low-resourced settings. A SBIRT programme, adopted by the Western Cape provincial government within an alcohol harm reduction strategy, employed various implementation strategies executed by a diverse team to translate an evidence-based intervention into services at three demonstration sites before broader programme scale-up. This paper evaluates the implementation of this programme delivered by facility-based counsellors in South African emergency centres. METHOD: Guided by the Consolidated Framework for Implementation Research, this mixed methods study evaluated the feasibility, acceptability, appropriateness and adoption of this task-shared SBIRT programme. Quantitative data were extracted from routinely collected health information. Qualitative interviews were conducted with 40 stakeholders in the programme's second year. RESULTS: In the first year, 13 136 patients were screened and 4 847 (37%) patients met criteria for risky substance use. Of these patients, 83% received the intervention, indicating programme feasibility. The programme was adopted into routine services and found to be acceptable and appropriate, particularly by stakeholders familiar with the emergency environment. These stakeholders highlighted the burden of substance-related harm in emergency centres and favourable patient responses to SBIRT. However, some stakeholders expressed scepticism of the behaviour change approach and programme compatibility with emergency centre operations. Furthermore, adoption was both facilitated and hampered by a top-down directive from provincial leadership to implement SBIRT, while rapid implementation limited effective engagement with a diverse stakeholder group. CONCLUSION: This is one of the first studies to address SBIRT implementation in low-resourced settings. The results show that SBIRT implementation and adoption was largely successful, and provide valuable insights that should be considered prior to implementation scale-up. Recommendations include ensuring ongoing monitoring and evaluation, and early stakeholder engagement to improve implementation readiness and programme compatibility in the emergency setting.

Adverse drug reactions in South African patients receiving bedaquiline-containing tuberculosis treatment: an evaluation of spontaneously reported cases.

BACKGROUND: Bedaquiline was recently introduced into World Health Organization (WHO)-recommended regimens for treatment of drug resistant tuberculosis. There is limited data on the long-term safety of bedaquiline. Because bedaquiline prolongs the QT interval, there are concerns regarding cardiovascular safety. The Western Cape Province in South Africa has an established pharmacovigilance programme: a targeted spontaneous reporting system which solicits reports of suspected adverse drug reactions (ADRs) in patients with HIV-1 and/or tuberculosis infection. Since 2015, bedaquiline has been included in the treatment regimens recommended for resistant tuberculosis in South Africa. We describe ADRs in patients on bedaquiline-containing tuberculosis treatment that were reported to the Western Cape Pharmacovigilance programme. METHODS: We reviewed reports of suspected ADRs and deaths received between March 2015 and June 2016 involving patients receiving bedaquiline-containing tuberculosis treatment. A multidisciplinary panel assessed causality, and categorised suspected ADRs using World Health Organisation-Uppsala Monitoring Centre system categories. "Confirmed ADRs" included all ADRs categorised as definite, probable or possible. Preventability was assessed using Schumock and Thornton criteria. Where a confirmed ADR occurred in a patient who died, the panel categorised the extent to which the ADR contributed to the patient's death as follows: major contributor, contributor or non-contributor. RESULTS: Thirty-five suspected ADRs were reported in 32 patients, including 13 deaths. There were 30 confirmed ADRs, of which 23 were classified as "possible" and seven as "probable". Bedaquiline was implicated in 22 confirmed ADRs in 22 patients. The most common confirmed ADR in patients receiving bedaquiline was QT prolongation (8 cases, 7 of which were severe). A fatal arrhythmia was suspected in 4 sudden deaths. These 4 patients were all taking bedaquiline together with other QT-prolonging drugs. There were 8 non-bedaquiline-associated ADRs, of which 7 contributed to deaths. CONCLUSIONS: Confirmed ADRs in patients receiving bedaquiline reflect the known safety profile of bedaquiline. Quantifying the incidence and clinical consequences of severe QT-prolongation in patients receiving bedaquiline-containing regimens is a research priority to inform recommendations for patient monitoring in treatment programmes for drug resistant tuberculosis. Pharmacovigilance systems within tuberculosis treatment programmes should be supported and encouraged, to provide ongoing monitoring of treatment-limiting drug toxicity.

Integrating a brief mental health intervention into primary care services for patients with HIV and diabetes in South Africa: study protocol for a trial-based economic evaluation.

INTRODUCTION: Depression and alcohol use disorders are international public health priorities for which there is a substantial treatment gap. Brief mental health interventions delivered by lay health workers in primary care services may reduce this gap. There is limited economic evidence assessing the cost-effectiveness of such interventions in low-income and middle-income countries. This paper describes the proposed economic evaluation of a health systems intervention testing the effectiveness, cost-effectiveness and cost-utility of two task-sharing approaches to integrating services for common mental disorders with HIV and diabetes primary care services. METHODS AND ANALYSIS: This evaluation will be conducted as part of a three-armed cluster randomised controlled trial of clinical effectiveness. Trial clinical outcome measures will include primary outcomes for risk of depression and alcohol use, and secondary outcomes for risk of chronic disease (HIV and diabetes) treatment failure. The cost-effectiveness analysis will evaluate cost per unit change in Alcohol Use Disorder Identification Test and Centre for Epidemiological Studies scale on Depression scores as well as cost per unit change in HIV RNA viral load and haemoglobin A1c, producing results of provider and patient cost per patient year for each study arm and chronic disease. The cost utility analyses will provide results of cost per quality-adjusted life year gained. Additional analyses relevant for implementation including budget impact analyses will be conducted to inform the development of a business case for scaling up the country's investment in mental health services. ETHICS AND DISSEMINATION: The Western Cape Department of Health (WCDoH) (WC2016_RP6_9), the South African Medical Research Council (EC 004-2/2015), the University of Cape Town (089/2015) and Oxford University (OxTREC 2-17) provided ethical approval for this study. Results dissemination will include policy briefs, social media, peer-reviewed papers, a policy dialogue workshop and press briefings. TRIAL REGISTRATION NUMBER: PACTR201610001825405.

Assessing capability for implementing mental health counselling within primary care facilities in a middle-income country: A feasibility study.

WHAT IS ALREADY KNOWN ABOUT THIS TOPIC?: Integrating mental health counselling into primary care services is a recommended strategy for reducing the mental health treatment gap in low- and middle-income countries. To support this strategy, potential barriers to counselling integration must be identified and addressed. Organizational preparedness for implementation may influence the extent to which the introduction of counselling is successful. Features of primary care facilities associated with preparedness for the implementation of mental health counselling have not been explored. WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE?: This study uses a novel approach to explore variations in preparedness of primary care services to implement counselling and factors potentially associated with these variations. Findings suggest there is considerable variation in the preparedness of facilities to implement counselling. Organizational factors such as resource availability, management style and facility environment are potentially associated with capability for implementing mental health counselling. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Health planners could use this method to identify poorly functioning services that may benefit from additional interventions to build preparedness for counselling implementation. Future research should examine whether differences in facility preparedness impact on the implementation and outcomes of this service. Abstract Introduction Differences in primary care facilities' preparedness for implementing mental health counselling may affect the implementation process but have rarely been studied. Aim To assess the feasibility of using a novel methodological approach to explore variations in capability for implementing mental health counselling and factors potentially associated with this variation among primary care services in the Western Cape, South Africa. Methods Staff from 26 facilities participated in discussions about their facility's mental health implementation capability. Three researchers conducted observations of the facility's environment, staff-patient interactions and resources. We used qualitative comparative analysis to identify factors potentially associated with implementation capability. Results Facilities appeared to vary in their capability for implementing counselling services. The availability of person-centred health services, a therapeutic environment and sufficient human resources may be requirements for implementation preparedness. Other factors that seem to support preparedness include the availability of confidential space for counselling and an adequately managed facility. Discussion This study identified several features of well-functioning primary care facilities. Facilities with these features may be better prepared to implement a new counselling service. Implications for practice This method may identify facilities that are poorly prepared for implementation that could benefit from preparedness-building interventions. Whether differences in preparedness affect counselling outcomes is yet to be established.

Community health worker-delivered counselling for common mental disorders among chronic disease patients in South Africa: a feasibility study.

OBJECTIVES: To examine the feasibility and acceptability of integrating a 'designated' approach to community health worker (CHW)-delivered mental health counselling (where existing CHWs deliver counselling in addition to usual duties) and a 'dedicated' approach (where additional CHWs have the sole responsibility of delivering mental health counselling) into chronic disease care. DESIGN: A feasibility test of a designated and dedicated approach to CHW-delivered counselling and qualitative interviews of CHWs delivering the counselling. SETTING: Four primary healthcare clinics in the Western Cape, South Africa allocated to either a designated or dedicated approach and stratified by urban/rural status. PARTICIPANTS: Forty chronic disease patients (20 with HIV, 20 with diabetes) reporting hazardous alcohol use or depression. Interviews with seven CHWs. INTERVENTION: Three sessions of structured mental health counselling. MAIN OUTCOME MEASURES: We assessed feasibility by examining the proportion of patients who were willing to be screened, met inclusion criteria, provided consent, completed counselling and were retained in the study. Acceptability of these delivery approaches was assessed through qualitative interviews of CHWs. RESULTS: Regardless of approach, a fair proportion (67%) of eligible patients were willing to receive mental health counselling. Patients who screened positive for depression were more likely to be interested in counselling than those with hazardous alcohol only. Retention in counselling (85%) and the study (90%) was good and did not differ by approach. Both dedicated and designated CHWs viewed the counselling package as highly acceptable but requested additional training and support to facilitate implementation. CONCLUSIONS: Dedicated and designated approaches to CHW-delivered mental health counselling were matched in terms of their feasibility and acceptability. A comparative efficacy trial of these approaches is justified, with some adjustments to the training and implementation protocols to provide further support to CHWs.

Patient preferences for the integration of mental health counseling and chronic disease care in South Africa.

PURPOSE: To describe patient perceptions of the acceptability of integrating mental health counseling within primary care facilities in the Western Cape province of South Africa and their preferences for the way in which this care is delivered. PATIENTS AND METHODS: Qualitative interviews with 30 purposively selected patients receiving treatment for HIV or diabetes within primary care facilities who screened positive for depression using the Center for Epidemiological Studies Depression Scale or hazardous alcohol use through the Alcohol Use Disorders Identification Test. RESULTS: Participants articulated high levels of unmet need for mental health services and strong associations between poor mental health and the challenges of living with a chronic disease. Consequently, they considered it acceptable to offer screening and mental health counseling within the context of chronic disease care. They thought counseling would be highly relevant if it helped patients develop adaptive strategies for coping with stress and negative emotions. Irrespective of chronic disease, patients indicated a preference for lay counselors rather than existing clinicians as potential delivery agents, supporting a task-shared approach to mental health counseling delivery in primary care settings. Some expressed concern about the feasibility of using lay counselors already present in facilities to deliver this service, suggesting that additional counselors might be needed. CONCLUSION: Findings demonstrate a need for mental health counseling within the context of chronic disease care in South Africa. Task-shared approaches, using lay counselors, seem acceptable to patients - provided counselors are selected to ensure they possess the qualities associated with effective counselors. Findings have informed the design of a task-shared mental health program that is responsive to the preferences of patients with chronic diseases.

Brief interventions to address substance use among patients presenting to emergency departments in resource poor settings: a cost-effectiveness analysis.

BACKGROUND: There are limited data describing the cost-effectiveness of brief interventions for substance use in resource-poor settings. Using a patient and provider perspective, this study investigates the cost-effectiveness of a brief motivational interviewing (MI) intervention versus a combined intervention of MI and problem solving therapy (MI-PST) for reducing substance use among patients presenting to emergency departments, in comparison to a control group. METHODS: Effectiveness data were extracted from Project STRIVE (Substance use and Trauma InterVention) conducted in South Africa. Patients were randomised to either receive 1 session of MI (n = 113) or MI in addition to four sessions of PST (n = 109) or no intervention [control (n = 110)]. Costs included the direct health care costs associated with the interventions. Patient costs included out of pocket payments incurred accessing the MI-PST intervention. Outcome measures were patients' scores on the Alcohol, Smoking and Substance Use Involvement Screening Test (ASSIST) and the Centre for Epidemiological Studies Depression Scale (CES-D). RESULTS: Cost per patient was low in all three groups; US$16, US$33 and US$11, and for MI, MI-PST and control respectively. Outcomes were 0.92 (MI), 1.06 (MI-PST) and 0.88 (control) for ASSIST scores; and 0.74 (MI), 1.27 (MI-PST) and 0.53 (control) for CES-D scores. In comparison to the control group, the MI intervention costs an additional US$119 per unit reduction in ASSIST score, (US$20 for CES-D); MI-PST in comparison to MI costs US$131 or US$33 per unit reduction in ASSIST or CES-D scores respectively. The sensitivity analyses showed that increasing the number of patients who screened positive and thus received the intervention could improve the effectiveness and cost-effectiveness of the interventions. CONCLUSION: MI or MI-PST interventions delivered by lay counsellors have the potential to be cost-effective strategies for the reduction of substance use disorder and depressive symptoms among patients presenting at emergency departments in resource poor settings. Given the high economic, social and health care cost of substance use disorders in South Africa, these results suggest that these interventions should be carefully considered for future implementation.Trial registration This study is part of a trial registered with the Pan African Clinical Trial Registry (PACTR201308000591418).

Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial.

BACKGROUND: In low- and middle-income countries (LMIC), it is uncertain whether a "dedicated" approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a "designated" approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes. METHODS/DESIGN: This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models will model the effect of the interventions on primary and secondary outcomes. The cost-effectiveness of each approach will be assessed using incremental cost-effectiveness ratios. DISCUSSION: Study findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting. TRIAL REGISTRATION: Pan African Clinical Trials Registry, Trial registration number: ACTR201610001825403 . Registered 17 October 2016.

Readiness to change is a predictor of reduced substance use involvement: findings from a randomized controlled trial of patients attending South African emergency departments.

BACKGROUND: This study examines whether readiness to change is a predictor of substance use outcomes and explores factors associated with RTC substance use among patients at South African emergency departments. METHODS: We use data from participants enrolled into a randomized controlled trial of a brief substance use intervention conducted in three emergency departments in Cape Town, South Africa. RESULTS: In adjusted analyses, the SOCRATES "Recognition" (B = 11.6; 95 % CI = 6.2-17.0) and "Taking Steps" score (B = -9.5; 95 % CI = -15.5- -3.5) as well as alcohol problems (B = 4.4; 95 % CI = 0.9-7.9) predicted change in substance use involvement at 3 month follow-up. Severity of depression (B = 0.2; 95 % CI = 0.1-0.3), methamphetamine use (B = 3.4; 95 % CI = 0.5- 6.3) and substance-related injury (B = 1.9; 95 % CI = 0.6-3.2) were associated with greater recognition of the need for change. Depression (B = 0.1; 95 % CI = 0.04 -0.1) and methamphetamine use (B = 2.3; 95 % CI = 0.1 -4.2) were also associated with more ambivalence about whether to change. Participants who presented with an injury that was preceded by substance use were less likely to be taking steps to reduce their substance use compared to individuals who did not (B = -1.7; 95 % CI = -5.0- -0.6). CONCLUSION: Findings suggest that brief interventions for this population should include a strong focus on building readiness to change substance use through motivational enhancement strategies. Findings also suggest that providing additional support to individuals with depression may enhance intervention outcomes. TRIAL REGISTRATION: This trial registered with the Pan African Clinical Trial Registry (PACTR201308000591418) on 14/07/2013.

The importance of identified cause-of-death information being available for public health surveillance, actions and research.

An amendment to the South African Births and Deaths Registration Act has compromised efforts to strengthen local mortality surveillance to provide statistics for small areas and enable data linkage to provide information for public health actions. Internationally it has been recognised that a careful balance needs to be kept between protecting individual patient confidentiality and enabling effective public health intelligence to guide patient care and service delivery and prevent harmful exposures. This article describes the public health benefits of a local mortality surveillance system in the Western Cape Province, South Africa (SA), as well as its potential for improving the quality of vital statistics data with integration into the national civil registration and vital statistics system. It also identifies other important uses for identifiable cause-of-death data in SA that have been compromised by this legislation.

How far does family physician supply correlate with district health system performance?

BACKGROUND: Since 2011, a new cadre of family physicians, with 4 years of postgraduate training, was deployed in the district health services of the Western Cape, and tasked with a considerable range of duties aimed at a general improvement in care and health outcomes. There is a need to evaluate the contribution of these family physicians to the district health system. AIM: To develop a methodology for describing the correlation between family physician supply and district health system performance, clinical processes and outcomes, and to measure this correlation at baseline. METHOD: A cross-sectional study was undertaken that analysed data at an ecological level for the period of 01 April 2011 to 31 March 2012. This was a pilot project analysing data from the first year of a 4-year project. The correlations between family physician supply and 18 health system indicators were assessed within a logic model. The supplies of other categories of staff were also measured. RESULTS: Although most of the correlations with family physicians were positive, the study was unable to demonstrate any strong or statistically significant correlations at baseline. There were significant correlations with other categories of staff. CONCLUSIONS: This study developed a methodology for monitoring the relationship between family physician supply using routinely collected indicators of health system performance, clinical processes and outcomes over time. Additional research will also be needed to investigate the impact of family physicians and triangulate findings as this methodology has many limitations and potential confounding factors.

Development of a family physician impact assessment tool in the district health system of the Western Cape Province, South Africa.

BACKGROUND: Policy makers in Africa are ambivalent about the need for family physicians to strengthen district health services. Evidence on the impact of family physicians is therefore needed. The aim was to develop a tool to evaluate the impact of family physicians on district health services according to the six expected roles that have been defined nationally. METHODS: Mixed methods were used to develop, validate, pilot and test the reliability of the tool in the Western Cape Province, South Africa. An expert panel validated the content and construction of the tool. The tool was piloted by 94 respondents who evaluated eight family physicians. Cronbach alpha scores were calculated to test the reliability of the tool. The impact of these family physicians in the pilot study was also analysed. RESULTS: A draft tool was successfully developed, validated, and proved reliable (Cronbach alpha >0.8). The overall scores (scale of 1-4) were: Care provider = 3.5, Consultant = 3.4, Leader and champion of clinical governance = 3.4, Capacity builder = 3.3, Clinical trainer and supervisor = 3.2 and Champion of community-orientated primary care (COPC) = 3.1. The impact on COPC was significantly less than the impact of other roles (p < 0.05). CONCLUSION: The Family Physician Impact Evaluation Tool can be used to measure the impact of family physicians in South Africa. The pilot study shows that the family physicians are having most impact in terms of clinical care and clinical governance, and a lesser impact in terms of clinical training, capacity-building and especially COPC.

Health research in the Western Cape province, South Africa: lessons and challenges.

BACKGROUND: Health research can play a critical role in strengthening health systems.However, little monitoring of health research is conducted in African countries to identify whether research contributes to addressing local health priorities.Aim/Setting: To review the profile of research on the health service platform in the Western Cape province of South Africa which was approved by the health authorities over the period January 2011 to December 2012. METHODS: Databases held by both the Provincial and City of Cape Town health departments were reviewed. Descriptions of research institution, location of research, topic and funding size and source were analysed. RESULTS: Of the health research approved in the province, 56% of projects were located on the District Health Services platform and 70% were based in the Cape Metropolitan area. For projects reporting budgetary information, the total funding was US $29.2 million. The primary focus of research was on HIV and tuberculosis (TB), whilst relatively few studies addressed nutrition, mental health or injury and there was little health systems research. Research funding was dominated by very large grants from foreign funders for HIV and/or TB research. South African government sources comprised less than 8% of all health research funding. CONCLUSION: There is a partial mismatch of donor funding to local health priorities. Greater focus on neglected areas such as mental health, trauma, nutrition and non-communicable disease, as well as greater investment in health systems research, is needed. Unless governments increase funding for research and a culture of research translation is achieved, health research will have limited impact on both local and national priorities.

Assessment of the impact of family physicians in the district health system of the Western Cape, South Africa.

BACKGROUND: In 2007, South Africa made family medicine a new speciality. Family physicians that have trained for this new speciality have been employed in the district health system since 2011. The aim of the present study was to explore the perceptions of district managers on the impact of family physicians on clinical processes, health system performance and health outcomes in the district health system (DHS) of the Western Cape. METHODS: Nine in-depth interviews were performed: seven with district managers and two with the chief directors of the metropolitan and rural DHS. Interviews were recorded, transcribed and analysed using the ATLAS-ti and the framework method. RESULTS: There was a positive impact on clinical processes for HIV/AIDS, TB, trauma, noncommunicable chronic diseases, mental health, maternal and child health. Health system performance was positively impacted in terms of access, coordination, comprehensiveness and efficiency. An impact on health outcomes was anticipated. The impact was not uniform throughout the province due to different numbers of family physicians and different abilities to function optimally. There was also a perception that the positive impact attributed to family physicians was in the early stages of development. Unanticipated effects included concerns with their roles in management and training of students, as well as tensions with career medical officers. CONCLUSION: Early feedback from district managers suggests that where family physicians are employed and able to function optimally, they are making a significant impact on health system performance and the quality of clinical processes. In the longer term, this is likely to impact on health outcomes.