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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.

ABSTRACT: 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.

SUBMITTER: Mutyambizi-Mafunda V

PROVIDER: S-EPMC6530312 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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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.

Mutyambizi-Mafunda Vimbayi V Myers Bronwyn B Sorsdahl Katherine K Lund Crick C Naledi Tracey T Cleary Susan S

BMJ open 20190514 5

<h4>Introduction</h4>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 effecti ...[more]

PMID: 31092660

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Project description:BackgroundIntegration of human immunodeficiency virus (HIV) care into primary care services is one strategy proposed to achieve universal access to antiretroviral treatment (ART) for HIV-positive patients in high burden countries. There is a need for controlled studies of programmes to integrate HIV care with details of the services being integrated.MethodsA semi-quantitative questionnaire was developed in consultation with clinic staff, tested for internal consistency using Cronbach's alpha coefficients and checked for inter-observer reliability. It was used to conduct four assessments of the integration of HIV care into referring primary care clinics (mainstreaming HIV) and into the work of all nurses within ART clinics (internal integration) and the integration of pre-ART and ART care during the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) trial in South Africa. Mean total integration and four component integration scores at intervention and control clinics were compared using one way analysis of variance (ANOVA). Repeated measures ANOVA was used to analyse changes in scores during the trial.ResultsCronbach's alpha coefficients for total integration, pre-ART and ART integration and mainstreaming HIV and internal integration scores showed good internal consistency. Mean total integration, mainstreaming HIV and ART integration scores increased significantly at intervention clinics by the third assessment. Mean pre-ART integration scores were almost maximal at the first assessment and showed no further change. There was no change in mean internal integration score.ConclusionThe questionnaire developed in this study is a valid tool with potential for monitoring integration of HIV care in other settings. The STRETCH trial interventions resulted in increased integration of HIV care, particularly ART care, by providing HIV care at referring primary care clinics, but had no effect on integrating HIV care into the work of all nurses with the ART clinic.

Project description:BackgroundThe treatment gap for mental illness in Nigeria, as in other sub-Saharan countries, is estimated to be around 85%. There is need to prioritise mental health care in low and middle income countries by providing a strong body of evidence for effective services, particularly with a view to increasing international and government confidence in investment in scaling up appropriate services. This paper lays out the processes by which a programme to integrate evidence-based mental health care into primary care services in Nigeria was designed, including a research framework to provide evidence from a robust evaluation.MethodsThis paper forms the first step in the overall process evaluation of the mhSUN intervention, where standard research practice indicates that the intervention, and its development, is clearly documented prior to subsequent evaluation. The report covers the period of programme development and evaluation design, and study site and design was chosen to allow generalisability and practical conclusions to be drawn for service development in Nigeria. In order to design an intervention that was informed by evidence and took into account local context and input of stakeholders, a structured process was followed, including: (1) Engagement of relevant stakeholders for information gathering and buy-in; (2) Literature review and gathering of pertinent evidence; (3) Situation analysis at a national and local level; (4) Model development (using Theory of Change); (5) Ongoing consultation, recognising the iterative nature of Theory of Change, and need for ongoing refinement of complex interventions.ResultsThe different sections of the structured approach resulted in outputs that built the necessary components (literature review, situation analysis) for informing the Theory of Change. A Theory of Change map is presented, which includes transparent documentation of the assumptions and logic behind the activities to drive the desired change. In addition, it documents the indicators necessary to measure fidelity and draw conclusions as to hypothesised effects of different mechanisms of action in subsequent evaluation.ConclusionIn addition to the details of ensuring robust evaluation design, there are a number of considerations that are particular to the context that must be taken into account in programme development, including the relationships between ultimate beneficiaries, implementers, host government and institutions, donors, and programme evaluators. Structured methods from existing frameworks can be drawn upon to use and collate relevant information to maximise the local applicability of a generic evidence base. Theory of Change, with its documented assumptions can form the basis of subsequent evaluation and iterative programme refinement, contributing to a more scientifically valid means of developing mental health programmes for scale up.

Project description:BACKGROUND:Gaps in maternal and child health services can slow progress towards achieving the Sustainable Development Goals. The Management and Optimization of Nutrition, Antenatal, Reproductive, Child Health & HIV Care (MONARCH) study will evaluate a Continuous Quality Improvement (CQI) intervention targeted at improving antenatal and postnatal health service outcomes in rural South Africa where HIV prevalence among pregnant women is extremely high. Specifically, it will establish the effectiveness of CQI on viral load (VL) testing in pregnant women who are HIV-positive and repeat HIV testing in pregnant women who are HIV-negative. METHODS:This is a stepped-wedge cluster-randomised controlled trial (RCT) of 7 nurse-led primary healthcare clinics to establish the effect of CQI on selected routine antenatal and postnatal services. Each clinic was a cluster, with the exception of the two smallest clinics, which jointly formed one cluster. The intervention was applied at the cluster level, where staff received training on CQI methodology and additional mentoring as required. In the control exposure state, the clusters received the South African Department of Health standard of care. After a baseline data collection period of 2 months, the first cluster crossed over from control to intervention exposure state; subsequently, one additional cluster crossed over every 2 months. The six clusters were divided into 3 groups by patient volume (low, medium and high). We randomised the six clusters to the sequences of crossing over, such that both the first three and the last three sequences included one cluster with low, one with medium, and one with high patient volume. The primary outcome measures were (i) viral load testing among pregnant women who were HIV-positive, and (ii) repeat HIV testing among pregnant women who were HIV-negative. Consenting women ?18 years attending antenatal and postnatal care during the data collection period completed outcome measures at delivery, and postpartum at three to 6 days, and 6 weeks. Data collection started on 15 July 2015. The total study duration, including pre- and post-exposure phases, was 19 months. Data will be analyzed by intention-to-treat based on first booked clinic of study participants. DISCUSSION:The results of the MONARCH trial will establish the effectiveness of CQI in improving antenatal and postnatal clinic processes in primary care in sub-Saharan Africa. More generally, the results will contribute to our knowledge on quality improvement interventions in resource-poor settings. TRIAL REGISTRATION:This trial was registered on 10 December 2015: www.clinicaltrials.gov, identifier NCT02626351 .

Project description:BackgroundParenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening.MethodsThe trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction.ResultsImprovements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence.ConclusionsSimultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.

Project description:AIMS:Unhealthy alcohol use is common among adults, and in particular, Veterans. Routine alcohol screening followed by brief intervention is recommended and considered a prevention priority in primary care settings. While previous studies have found that Veterans enrolled in the Veteran's Health Administration (VA) receive high rates of screening and brief intervention, less than 50% of Veterans receive VA health care. No study has evaluated receipt of these services in a general sample of Veterans. Therefore, in a nationally-representative sample, we examine whether Veteran status was associated with receiving alcohol screening and brief intervention in primary care. METHODS:Using the Centers for Disease Control and Prevention's 2014 Behavioral Risk Factor Surveillance System data, we identified adults who endorsed visiting a doctor for routine checkup at least once in the past two years and responded to an optional module assessing alcohol-related care (N?=?92,206; 14.1% Veterans). Multivariable logistic regression was used to assess the association between Veteran status and screening and brief intervention outcomes. We also evaluate differences in alcohol-related care across Veteran status stratified by gender. Models were adjusted for sociodemographic and clinical characteristics likely to confound the association. RESULTS:Overall, Veterans were more likely than non-Veterans to be screened for alcohol quantity and heavy episodic drinking (ps?<?0.05), and more likely to endorse receiving brief intervention advice about alcohol's harmful effects (p?<?.001). Veteran status predicted an increased likelihood of being screened and receipt of advice about alcohol's harmful effects, but did not predict the likelihood of receiving advice to reduce or abstain from drinking (AOR?=?1.00, 95% C.I. [0.80-1.26]). Analyses stratified by gender indicated a similar pattern of results for males as the overall sample. Results among females indicated Veteran status predicted the likelihood of being asked about heavy episodic drinking (AOR?=?1.47, 95% C.I. [1.09-1.99]) and being offered advice about the harmful effects of alcohol (AOR?=?1.62, 95% C.I. [1.06-2.48]). Female Veterans were not more likely than female non-Veterans to be advised to reduce and/or abstain from drinking. CONCLUSIONS:Screening about any alcohol use was common while report of screening for quantity and heavy episodic drinking occurrence and report of brief intervention were less common. Veterans were more likely than non-Veterans to report receiving recommended care, though rates of advice to reduce or abstain from drinking did not differ across groups. Persistent gaps in delivery of recommended alcohol-related care, especially for particularly vulnerable subpopulations such as women Veterans, suggest a need for quality improvement.

Project description:IntroductionWorldwide mental health disorders are associated with a considerable amount of human suffering, disability and mortality. Yet, the provision of rapid evidence-based care to mitigate the human and economic costs of these disorders is limited. The greatest progress in developing and delivering early intervention services has occurred within psychosis. There is now growing support for and calls to extend such approaches to other diagnostic groups. The aim of this scoping review is to systematically map the emerging literature on early intervention services for non-psychotic mental health disorders, with a focus on outlining how services are structured, implemented and scaled.Methods and analysisThe protocol was developed using the guidance for scoping reviews in the Joanna Briggs Institute manual and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews checklist. A systematic search for published and unpublished literature will be conducted using the following databases: (1) MEDLINE, (2) PsycINFO, (3) HMIC, (4) EMBASE and (5) ProQuest. To be included, documents must describe and/or evaluate an early intervention service for adolescents or adults with a non-psychotic mental health disorder. There will be no restrictions on publication type, study design and date. Title and abstract, and full-text screening will be completed by one reviewer, with a proportion of articles screened in duplicate. Data analysis will primarily involve a qualitatively summary of the early intervention literature, the characteristics of early intervention services and key findings relating to their evaluation and implementation.Ethics and disseminationThe synthesis of published and unpublished articles will not require ethical approval. The results of this scoping review will be published in a peer-reviewed journal and disseminated via social media, conference presentations and other knowledge translation activities.

Project description:BackgroundPoor engagement in postpartum maternal HIV care is a challenge worldwide and contributes to adverse maternal outcomes and vertical transmission. Our objective was to project the clinical and economic impact of integrated postpartum maternal antiretroviral therapy (ART) and pediatric care in South Africa.MethodsUsing the CEPAC computer simulation models, parameterized with data from the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) randomized controlled trial, we evaluated the cost-effectiveness of integrated postpartum care for women initiating ART in pregnancy and their children. We compared two strategies: 1) standard of care (SOC) referral to local clinics after delivery for separate standard ART services for women and pediatric care for infants, and 2) the MCH-ART intervention (MCH-ART) of co-located maternal/pediatric care integrated in Maternal and Child Health (MCH) services throughout breastfeeding. Trial-derived inputs included: 12-month maternal retention in care and virologic suppression (SOC: 49%, MCH-ART: 67%), breastfeeding duration (SOC: 6 months, MCH-ART: 8 months), and postpartum healthcare costs for mother-infant pairs (SOC: $50, MCH-ART: $69). Outcomes included pediatric HIV infections, maternal and infant life expectancy (LE), lifetime HIV-related per-person costs, and incremental cost-effectiveness ratios (ICERs; ICER <US$903/YLS considered "cost-effective").ResultsCompared to SOC, MCH-ART increased maternal LE (SOC: 25.26 years, MCH-ART: 26.20 years) and lifetime costs (SOC: $9,912, MCH-ART: $10,207; discounted). Projected pediatric outcomes for all HIV-exposed children were similar between arms, although undiscounted LE for HIV-infected children was shorter in SOC (SOC: 23.13 years, MCH-ART: 23.40 years). Combining discounted maternal and pediatric outcomes, the ICER was $599/YLS.ConclusionCo-located maternal HIV and pediatric care, integrated in MCH services throughout breastfeeding, is a cost-effective strategy to improve maternal and pediatric outcomes and should be implemented in South Africa.

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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.

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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.

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