Optima TB: A tool to help optimally allocate tuberculosis spending.

Approximately 85% of tuberculosis (TB) related deaths occur in low- and middle-income countries where health resources are scarce. Effective priority setting is required to maximise the impact of limited budgets. The Optima TB tool has been developed to support analytical capacity and inform evidence-based priority setting processes for TB health benefits package design. This paper outlines the Optima TB framework and how it was applied in Belarus, an upper-middle income country in Eastern Europe with a relatively high burden of TB. Optima TB is a population-based disease transmission model, with programmatic cost functions and an optimisation algorithm. Modelled populations include age-differentiated general populations and higher-risk populations such as people living with HIV. Populations and prospective interventions are defined in consultation with local stakeholders. In partnership with the latter, demographic, epidemiological, programmatic, as well as cost and spending data for these populations and interventions are then collated. An optimisation analysis of TB spending was conducted in Belarus, using program objectives and constraints defined in collaboration with local stakeholders, which included experts, decision makers, funders and organisations involved in service delivery, support and technical assistance. These analyses show that it is possible to improve health impact by redistributing current TB spending in Belarus. Specifically, shifting funding from inpatient- to outpatient-focused care models, and from mass screening to active case finding strategies, could reduce TB prevalence and mortality by up to 45% and 50%, respectively, by 2035. In addition, an optimised allocation of TB spending could lead to a reduction in drug-resistant TB infections by 40% over this period. This would support progress towards national TB targets without additional financial resources. The case study in Belarus demonstrates how reallocations of spending across existing and new interventions could have a substantial impact on TB outcomes. This highlights the potential for Optima TB and similar modelling tools to support evidence-based priority setting.

Diabetes care cascade in Ukraine: an analysis of breakpoints and opportunities for improved diabetes outcomes.

BACKGROUND: Diabetes is one of the leading causes of poor health and high care costs in Ukraine. To prevent diabetes complications and alleviate the financial burden of diabetes care on patients, the Ukrainian government reimburses diabetes medication and provides glucose monitoring, but there are significant gaps in the care continuum. We estimate the costs of providing diabetes care and the most cost-effective ways to address these gaps in the Poltava region of Ukraine. METHODS: We gathered data on the unit costs of diabetes interventions in Poltava and estimated expenditure on diabetes care. We estimated the optimal combination of facility-based and outreach screening and investigated how additional funding could best be allocated to improve glucose control outcomes. RESULTS: Of the ~ 40,000 adults in diabetes care, only ~ 25% achieved sustained glucose control. Monitoring costs were higher for those who did not: by 10% for patients receiving non-pharmacological treatment, by 61% for insulin patients, and twice as high for patients prescribed oral treatment. Initiatives to improve treatment adherence (e.g. medication copayment schemes, enhanced adherence counseling) would address barriers along the care continuum and we estimate such expenditures may be recouped by reductions in patient monitoring costs. Improvements in case detection are also needed, with only around two-thirds of estimated cases having been diagnosed. Outreach screening campaigns could play a significant role: depending on how well-targeted and scalable such campaigns are, we estimate that 10-46% of all screening could be conducted via outreach, at a cost per positive patient identified of US$7.12-9.63. CONCLUSIONS: Investments to improve case detection and treatment adherence are the most efficient interventions for improved diabetes control in Poltava. Quantitative tools provide essential decision support for targeting investment to close the gaps in care.

Adherence clubs and decentralized medication delivery to support patient retention and sustained viral suppression in care: Results from a cluster-randomized evaluation of differentiated ART delivery models in South Africa.

BACKGROUND: Differentiated antiretroviral therapy (ART) delivery models, in which patients are provided with care relevant to their current status (e.g., newly initiating, stable on treatment, or unstable on treatment) has become an essential part of patient-centered health systems. In 2015, the South African government implemented Chronic Disease Adherence Guidelines (AGLs), which involved five interventions: Fast Track Initiation Counseling for newly initiating patients, Enhanced Adherence Counseling for patients with an unsuppressed viral load, Early Tracing of patients who miss visits, and Adherence Clubs (ACs) and Decentralized Medication Delivery (DMD) for stable patients. We evaluated two of these interventions in 24 South African facilities: ACs, in which patients meet in groups outside usual clinic procedures and receive medication; and DMD, in which patients pick up their medication outside usual pharmacy queues. METHODS AND FINDINGS: We compared those participating in ACs or receiving DMD at intervention sites to those eligible for ACs or DMD at control sites. Outcomes were retention and sustained viral suppression (<400 copies/mL) 12 months after AC or DMD enrollment (or comparable time for controls). 12 facilities were randomly allocated to intervention and 12 to control arms in four provinces (Gauteng, North West, Limpopo, and KwaZulu Natal). We calculated adjusted risk differences (aRDs) with cluster adjustment using generalized estimating equations (GEEs) using difference in differences (DiD) with patients eligible for ACs/DMD prior to implementation (Jan 1, 2015) for comparison. For DMD, randomization was not preserved, and the analysis was treated as observational. For ACs, 275 intervention and 294 control patients were enrolled; 72% of patients were female, 61% were aged 30-49 years, and median CD4 count at ART initiation was 268 cells/µL. AC patients had higher 1-year retention (89.5% versus 81.6%, aRD: 8.3%; 95% CI: 1.1% to 15.6%) and comparable sustained 1-year viral suppression (<400 copies/mL any time ≤ 18 months) (80.0% versus 79.6%, aRD: 3.8%; 95% CI: -6.9% to 14.4%). Retention associations were apparently stronger for men than women (men RD: 13.1%, 95% CI: 0.3% to 23.5%; women RD: 6.0%, 95% CI: -0.9% to 12.9%). For DMD, 232 intervention and 346 control patients were enrolled; 71% of patients were female, 65% were aged 30-49 years, and median CD4 count at ART initiation was 270 cells/µL. DMD patients had apparently lower retention (81.5% versus 87.2%, aRD: -5.9%; 95% CI: -12.5% to 0.8%) and comparable viral suppression versus standard of care (77.2% versus 74.3%, aRD: -1.0%; 95% CI: -12.2% to 10.1%), though in both cases, our findings were imprecise. We also noted apparently increased viral suppression among men (RD: 11.1%; 95% CI: -3.4% to 25.5%). The main study limitations were missing data and lack of randomization in the DMD analysis. CONCLUSIONS: In this study, we found comparable DMD outcomes versus standard of care at facilities, a benefit for retention of patients in care with ACs, and apparent benefits in terms of retention (for AC patients) and sustained viral suppression (for DMD patients) among men. This suggests the importance of alternative service delivery models for men and of community-based strategies to decongest primary healthcare facilities. Because these strategies also reduce patient inconvenience and decongest clinics, comparable outcomes are a potential success. The cost of all five AGL interventions and possible effects on reducing clinic congestion should be investigated. CLINICAL TRIAL REGISTRATION: NCT02536768.

Challenges and opportunities in the continuity of care for hypertension: a mixed-methods study embedded in a primary health care intervention in Tajikistan.

BACKGROUND: Hypertension, a significant risk factor for ischemic heart disease and other chronic conditions, is the third-highest cause of death and disability in Tajikistan. Thus, ensuring the early detection and appropriate management of hypertension is a core element of strategies to improve population health in Tajikistan. For a strategy to be successful, it should be informed by the causes of gaps in service delivery and feasible solutions to these challenges. The objective of this study was to undertake a systematic assessment of hypertension case detection and retention in care within Tajikistan's primary health care system, and to identify challenges and appropriate solutions. METHODS: Our mixed methods study drew on the cascade of care framework to examine patient progression through the recommended stages of hypertension care. We triangulated data from household surveys and facility registries within Tajikistan's Health Services Improvement Project (HSIP) to describe the cascade. Focus group discussions with local HSIP stakeholders identified the barriers to and facilitators for care. Drawing on global empirical evidence on effective interventions and stakeholder judgments on the feasibility of implementation, we developed recommendations to improve hypertension service delivery that were informed by our quantitative and qualitative findings. RESULTS: We review the results for the case detection stage of the cascade of care, which had the most significant gaps. Of the half a million people with hypertension in Khatlon and Sogd Oblasts (administrative regions), about 10% have been diagnosed in Khatlon and only 5% in Sogd. Barriers to case detection include misinformation about hypertension, ambiguous protocols, and limited delivery capacity. Solutions identified to these challenges were mobilizing faith-based organizations, scaling up screening through health caravans, task-shifting to increase provider supply, and introducing job aids for providers. CONCLUSIONS: Translating findings on discontinuities in care for hypertension and other chronic diseases to actionable policy insights can be facilitated by collaboration with local stakeholders, triangulation of data sources, and identifying the intersection between the feasible and the effective in defining solutions to service delivery challenges.

Effectiveness of interventions for unstable patients on antiretroviral therapy in South Africa: results of a cluster-randomised evaluation.

BACKGROUND: As loss from HIV care is an ongoing challenge globally, interventions are needed for patients who don't achieve or maintain ART stability. The 2015 South African National Adherence Guidelines (AGL) for Chronic Diseases include two interventions targeted at unstable patients: early tracing of patients who miss visits (TRIC) and enhanced adherence counselling (EAC). METHODS: As part of a cluster-randomised evaluation at 12 intervention and 12 control clinics in four provinces, intervention sites implemented the AGL interventions, while control sites retained standard care. We report on outcomes of EAC for patients with an elevated viral load (>400 copies/ml) and for TRIC patients who missed a visit by >5 days. We estimated risk differences (RD) of 3 and 12-month viral resuppression (<400 copies/ml) and 12-month retention with cluster adjustment using generalised estimating equations and controlled for imbalances using difference-in-differences compared to all eligible in 2015, prior to intervention roll-out. RESULTS: For EAC, we had 358 intervention and 505 control site patients (61% female, median ART initiation CD4 count 154 cells/µl). We found no difference between arms in 3-month resuppression (RD: -1.7%; 95%CI: -4.3% to 0.9%), but <20% of patients had a repeat viral load within 3 months (19.8% intervention, 13.5% control). Including the entire clinic population eligible for EAC with a repeat viral load at all evaluation sites (n = 934), intervention sites showed a small increase in 3-month resuppression (28% vs. 25%, RD 3.0%; 95%CI: -2.7% to 8.8%). Adjusting for baseline differences increased the RD to 8.1% (95% CI: -0.1% to 17.2%). However, we found no differences in 12-month suppression (RD: 1.5%; 95% CI: -14.1% to 17.1% but suppression was low overall at 40%) or retention (RD: 2.8%; 95% CI: -7.5% to 13.2%). For TRIC, we enrolled 155 at intervention sites and 248 at control sites (44% >40 years, 67% female, median CD4 count 212 cells/µl). We found no difference between groups in return to care by 12 months (RD: -6.8%; 95% CI: -17.7% to 4.8%). During the study period, control sites continued to use tracing within standard care, however, potentially masking intervention effects. CONCLUSIONS: Enhanced adherence counselling showed no benefit over 12 months. Implementation of the tracing intervention under the new guidelines was similar to the standard of care. Interventions that aim to return unstable patients to care should incorporate active monitoring to determine if the interventions are effective.

Cash transfers to enhance TB control: lessons from the HIV response.

BACKGROUND: The World Health Organization prioritises a more holistic global response to end the tuberculosis (TB) epidemic by 2030. Based on experiences in the HIV response, social protection, and in particular cash transfers, show promise for contributing to this. Currently, individual-level evidence for the potential of cash transfers to prevent TB by addressing the structural social determinants of disease is lacking. To identify priority actions for the TB research agenda, we appraised efforts by the HIV response to establish the role of cash transfers in preventing HIV infection. MAIN BODY: The HIV response has evaluated the effects of cash transfers on risky sexual behaviours and HIV incidence. Work has also evaluated the added effects of supplementing cash transfers with psychosocial support. The HIV response has focused research on populations with disproportionate HIV risk, and used a mix of explanatory evaluations, which use ideal conditions, and pragmatic evaluations, which use operational conditions, to generate evidence that is both causally valid and applicable to the real world. It has always collaborated with multiple stakeholders in funding and evaluating projects. Learning from the HIV response, priority actions for the TB response should be to investigate the effect of cash transfers on intermediary social determinants of active TB disease, and TB incidence, as well as the added effects of supplementing cash transfers with psychosocial support. Work should be focused on key groups in high burden settings, and look to build a combination of explanatory and pragmatic evidence to inform policy decisions in this field. To achieve this, there is an urgent need to facilitate collaborations between groups interested in evaluating the impact of cash transfers on TB risk. CONCLUSIONS: The HIV response highlights several priority actions necessary for the TB response to establish the potential of cash transfers to prevent TB by addresing the structural social determinants of disease.

Effectiveness of and Financial Returns to Voluntary Medical Male Circumcision for HIV Prevention in South Africa: An Incremental Cost-Effectiveness Analysis.

BACKGROUND: Empirical studies and population-level policy simulations show the importance of voluntary medical male circumcision (VMMC) in generalized epidemics. This paper complements available scenario-based studies (projecting costs and outcomes over some policy period, typically spanning decades) by adopting an incremental approach-analyzing the expected consequences of circumcising one male individual with specific characteristics in a specific year. This approach yields more precise estimates of VMMC's cost-effectiveness and identifies the outcomes of current investments in VMMC (e.g., within a fiscal budget period) rather than of investments spread over the entire policy period. METHODS/FINDINGS: The model has three components. We adapted the ASSA2008 model, a demographic and epidemiological model of the HIV epidemic in South Africa, to analyze the impact of one VMMC on HIV incidence over time and across the population. A costing module tracked the costs of VMMC and the resulting financial savings owing to reduced HIV incidence over time. Then, we used several financial indicators to assess the cost-effectiveness of and financial return on investments in VMMC. One circumcision of a young man up to age 20 prevents on average over 0.2 HIV infections, but this effect declines steeply with age, e.g., to 0.08 by age 30. Net financial savings from one VMMC at age 20 are estimated at US$617 at a discount rate of 5% and are lower for circumcisions both at younger ages (because the savings occur later and are discounted more) and at older ages (because male circumcision becomes less effective). Investments in male circumcision carry a financial rate of return of up to 14.5% (for circumcisions at age 20). The cost of a male circumcision is refinanced fastest, after 13 y, for circumcisions at ages 20 to 25. Principal limitations of the analysis arise from the long time (decades) over which the effects of VMMC unfold-the results are therefore sensitive to the discount rate applied, and more generally to the future course of the epidemic and of HIV/AIDS-related policies pursued by the government. CONCLUSIONS: VMMC in South Africa is highly effective in reducing both HIV incidence and the financial costs of the HIV response. The return on investment is highest if males are circumcised between ages 20 and 25, but this return on investment declines steeply with age.

The economics, financing and implementation of HIV treatment as prevention: what will it take to get there?

The 2013 Lancet Commission Report, Global Health 2035, rightly pointed out that we are at a unique place in history where a "grand convergence" of health initiatives to reduce both infectious diseases, and child and maternal mortality--diseases that still plague low income countries--would yield good returns in terms of development and health outcomes. This would also be a good economic investment. Such investments would support achieving health goals of reducing under-five (U5) mortality to 16 per 1000 live births, reducing deaths due to HIV/AIDS to 8 per 100,000 population, and reducing annual TB deaths to 4 per 100,000 population. Treatment as prevention (TasP) holds enormous potential in reducing HIV transmission, and morbidity and mortality associated with HIV/AIDS--and therefore contributing to Global Health 2035 goals. However, TasP requires large financial investments and poses significant implementation challenges. In this review, we discuss the potential effectiveness, financing and implementation of TasP. Overall, we conclude that TasP shows great promise as a cost-effective intervention to address the dual aims of reducing new HIV infections and reducing the global burden of HIV-related disease. Successful implementation will be no easy feat, though. The dramatic increases in the numbers of persons who need antiretroviral therapy (ART) under a TasP approach will pose enormous challenges at all stages of the HIV treatment cascade: HIV diagnosis, antiretroviral (ARV) initiation, ARV adherence and retention, and increased drug resistance with long-term enrolment on ART. Overcoming these implementation challenges will require targeted implementation, not focusing exclusively on TasP, most-at-risk population (MARP)-friendly services for key populations, integrating services, task shifting, more efficient programme management, balancing supply and demand, integration into universal health coverage efforts, demand creation, improved ART retention and adherence strategies, the use of incentives to improve HIV treatment outcomes and reduce unit costs, continued operational research and tapping into technological innovations.

Evaluation of the use of modelling in resource allocation decisions for HIV and TB.

INTRODUCTION: Globally, resources for health spending, including HIV and tuberculosis (TB), are constrained, and a substantial gap exists between spending and estimated needs. Optima is an allocative efficiency modelling tool that has been used since 2010 in over 50 settings to generate evidence for country-level HIV and TB resource allocation decisions. This evaluation assessed the utilisation of modelling to inform financing priorities from the perspective of country stakeholders and their international partners. METHODS: In October to December 2021, the World Bank and Burnet Institute led 16 semi-structured small-group virtual interviews with 54 representatives from national governments and international health and funding organisations. Interviews probed participants' roles and satisfaction with Optima analyses and how model findings have had been used and impacted resource allocation. Interviewed stakeholders represented nine countries and 11 different disease programme-country contexts with prior Optima modelling analyses. Interview notes were thematically analysed to assess factors influencing the utilisation of modelling evidence in health policy and outcomes. RESULTS: Common influences on utilisation of Optima findings encompassed the perceived validity of findings, health system financing mechanisms, the extent of stakeholder participation in the modelling process-including engagement of funding organisations, sociopolitical context and timeliness of the analysis. Using workshops can facilitate effective stakeholder engagement and collaboration. Model findings were often used conceptually to localise global evidence and facilitate discussion. Secondary outputs included informing strategic and financial planning, funding advocacy, grant proposals and influencing investment shifts. CONCLUSION: Allocative efficiency modelling has supported evidence-informed decision-making in numerous contexts and enhanced the conceptual and practical understanding of allocative efficiency. Most immediately, greater involvement of country stakeholders in modelling studies and timing studies to key strategic and financial planning decisions may increase the impact on decision-making. Better consideration for integrated disease modelling, equity goals and financing constraints may improve relevance and utilisation of modelling findings.

How to do (or not to do) health resource allocations using constrained mathematical optimization.

Despite the push towards evidence-based health policy, decisions about how to allocate health resources are all too often made on the basis of political forces or a continuation of the status quo. This results in wastage in health systems and loss of potential population health. However, if health systems are to serve people best, then they must operate efficiently and equitably, and appropriate valuation methods are needed to determine how to do this. With the advances in computing power over the past few decades, advanced mathematical optimization algorithms can now be run on personal computers and can be used to provide comprehensive, evidence-based recommendations for policymakers on how to prioritize health spending considering policy objectives, interactions of interventions, real-world system constraints and budget envelopes. Such methods provide an invaluable complement to traditional or extended cost-effectiveness analyses or league tables. In this paper, we describe how such methods work, how policymakers and programme managers can access them and implement their recommendations and how they have changed health spending in the world to date.

Public health benefits of shifting from hospital-focused to ambulatory TB care in Eastern Europe: Optimising TB investments in Belarus, the Republic of Moldova, and Romania.

High rates of drug-resistant tuberculosis (DR-TB) continue to threaten public health, especially in Eastern Europe. Costs for treating DR-TB are substantially higher than treating drug-susceptible TB, and higher yet if DR-TB services are delivered in hospital. The WHO recommends that multidrug-resistant (MDR) TB be treated using mainly ambulatory care, shown to have non-inferior health outcomes, however, there has been a delay to transition away from hospital-focused MDR-TB care in certain Eastern European countries. Allocative efficiency analyses were conducted for three countries in Eastern Europe, Belarus, the Republic of Moldova, and Romania, to minimise a combination of TB incidence, prevalence, and mortality by 2035. A primary focus of these studies was to determine the health benefits and financial savings that could be realised if DR-TB service delivery shifted from hospital-focused to ambulatory care. Here we provide a comprehensive assessment of findings from these studies to demonstrate the collective benefit of transitioning from hospital-focused to ambulatory TB care, and to address common regional considerations. We highlight that transitioning from hospital-focused to ambulatory TB care could reduce treatment costs by 20% in Romania, 24% in Moldova, and by as much as 40% in Belarus or almost 35 million US dollars across these three countries by 2035 without affecting quality of care. Improved TB outcomes could be achieved, however, without additional spending by reinvesting these savings in higher-impact TB diagnosis and more efficacious DR-TB treatment regimens. We found commonalities in the large portion of TB cases treated in hospital across these three regional countries, and similar obstacles to transitioning to ambulatory care. National governments in the Eastern European region should examine barriers delaying adoption of ambulatory DR-TB care and consider lost opportunities caused by delays in switching to more efficient treatment modes.

Improving services for chronic non-communicable diseases in Samoa: an implementation research study using the care cascade framework.

OBJECTIVE: Samoa needs to intensify the response to the growing non-communicable disease burden. This study aimed to assess bottlenecks in the care continuum and identify possible solutions. METHODS: The mixed-methods study used the cascade framework as an analysis tool and hypertension as a tracer condition for chronic non-communicable diseases. Household survey data were integrated with medical record data of hypertension patients and results from focus group discussions with patients and healthcare providers. RESULTS: Hypertension prevalence was 38.1% but only 4.7% of hypertensive individuals had controlled blood pressure. There were large gaps in the care continuum especially at screening and referral due to multiple socio-cultural, economic and service delivery constraints. CONCLUSIONS: In Samoa, care for chronic non-communicable diseases is not effectively addressing patient needs. This calls for better health communication, demand creation, treatment support, nutritional interventions and health service redesign, with a focus on primary healthcare and effective patient and community engagement. Implications for public health: The proposed actions can improve the reach, accessibility, quality and effectiveness of Samoa's chronic care services. Health system redesign is necessary to ensure continuity of care and more effective primary prevention. The findings are useful for other countries in the region facing similar challenges.

Impacts of COVID-19-related service disruptions on TB incidence and deaths in Indonesia, Kyrgyzstan, Malawi, Mozambique, and Peru: Implications for national TB responses.

Initial global-level estimates reported in June 2020 by the World Health Organization suggested that levels of disruption to TB service delivery could be as high as 25%-50% and result in an additional 6·3 million cases of tuberculosis (TB) and an additional 1·4 million TB-related deaths attributable to COVID-19 between 2020 and 2025. Quarterly epidemiological estimates and programmatic TB data capturing disruption levels to each TB service were collected by National TB Programmes in Indonesia, Kyrgyzstan, Malawi, Mozambique, and Peru. Data from 2019, for a pre-COVID-19 baseline, and throughout 2020, together with the NTP's COVID-19 response plans, were used within Optima TB models to project TB incidence and deaths over five years because of COVID-19-related disruptions, and the extent to which those impacts may be mitigated through proposed catch-up strategies in each country. Countries reported disruptions of up to 64% to demand-driven TB diagnosis. However, TB service availability disruptions were shorter and less severe, with TB treatment experiencing levels of disruption of up to 21%. We predicted that under the worse-case scenario cumulative new latent TB infections, new active TB infections, and TB-related deaths could increase by up to 23%, 11%, and 20%, respectively, by 2024. However, three of the five countries were on track to mitigate these increases to 3% or less by maintaining TB services in 2021 and 2022 and by implementing proposed catch-up strategies. Indonesia was already experiencing the worse-case scenario, which could lead to 270,000 additional active TB infections and 36,000 additional TB-related deaths by the end of 2024. The COVID-19 pandemic is projected to negatively affect progress towards 2035 End TB targets, especially in countries already off-track. Findings highlight both successful TB service delivery adaptions in 2020 and the need to proactively maintain TB service availability despite potential future waves of more transmissible COVID-19 variants.

Using allocative efficiency analysis to inform health benefits package design for progressing towards Universal Health Coverage: Proof-of-concept studies in countries seeking decision support.

BACKGROUND: Countries are increasingly defining health benefits packages (HBPs) as a way of progressing towards Universal Health Coverage (UHC). Resources for health are commonly constrained, so it is imperative to allocate funds as efficiently as possible. We conducted allocative efficiency analyses using the Health Interventions Prioritization tool (HIPtool) to estimate the cost and impact of potential HBPs in three countries. These analyses explore the usefulness of allocative efficiency analysis and HIPtool in particular, in contributing to priority setting discussions. METHODS AND FINDINGS: HIPtool is an open-access and open-source allocative efficiency modelling tool. It is preloaded with publicly available data, including data on the 218 cost-effective interventions comprising the Essential UHC package identified in the 3rd Edition of Disease Control Priorities, and global burden of disease data from the Institute for Health Metrics and Evaluation. For these analyses, the data were adapted to the health systems of Armenia, Côte d'Ivoire and Zimbabwe. Local data replaced global data where possible. Optimized resource allocations were then estimated using the optimization algorithm. In Armenia, optimized spending on UHC interventions could avert 26% more disability-adjusted life years (DALYs), but even highly cost-effective interventions are not funded without an increase in the current health budget. In Côte d'Ivoire, surgical interventions, maternal and child health and health promotion interventions are scaled up under optimized spending with an estimated 22% increase in DALYs averted-mostly at the primary care level. In Zimbabwe, the estimated gain was even higher at 49% of additional DALYs averted through optimized spending. CONCLUSIONS: HIPtool applications can assist discussions around spending prioritization, HBP design and primary health care transformation. The analyses provided actionable policy recommendations regarding spending allocations across specific delivery platforms, disease programs and interventions. Resource constraints exacerbated by the COVID-19 pandemic increase the need for formal planning of resource allocation to maximize health benefits.

Short-term Outcomes from a Cluster Randomized Evaluation of Adherence Clubs as Part of Differentiated HIV Care in South Africa.

BACKGROUND: Differentiated care has been proposed to improve HIV treatment outcomes. In June 2016, South Africa's National Department of Health in collaboration with researchers began an evaluation of its National Adherence Guidelines for Chronic Diseases (AGL) which was being rolled-out by NDOH to public sector health facilities. METHODS: The evaluation has a cluster-randomized design with 12 intervention and 12 control facilities in 4 provinces. Follow up was by passive surveillance using clinical records. Enrollment occurred between June-December 2016. Our primary outcome was receipt of ART through Adherence Clubs (AC) within the first 4 months after AC eligibility. We compared crude results, used baseline covariate adjustment and difference-in-differences approaches to assess effects of ACs. RESULTS: We enrolled 275 patients from ACs and 294 control arm patients. About 57% were <40 years and just over 70% were female. At ART initiation average CD4 count was 268 cells (range 157-379). ACs showed a benefit in crude analyses of a 4 percentage point increase in patients picking up their medication (RD 4.4%; 95% CI: -0.6% to 9.4%) which increased to 6.7 percentage points (95% CI: 3.4% to 10.4%) after adjusting for baseline differences. The difference remained after adjusting for clusters and baseline covariates, though the confidence interval widened (RD 7.5%; 95% CI: -1.3% to 16.2%). CONCLUSIONS: We found early benefits to ACs in terms of medication pickups, though our results lacked precision. As we progress to long-term outcomes, it is important to see if these early gains translate into improved retention and viral suppression.

Fast-track treatment initiation counselling in South Africa: A cost-outcomes analysis.

INTRODUCTION: In 2016, under its new National Adherence Guidelines (AGL), South Africa formalized an existing model of fast-track HIV treatment initiation counselling (FTIC). Rollout of the AGL included an evaluation study at 24 clinics, with staggered AGL implementation. Using routinely collected data extracted as part of the evaluation study, we estimated and compared the costs of HIV care and treatment from the provider's perspective at the 12 clinics implementing the new, formalized model (AGL-FTIC) to costs at the 12 clinics continuing to implement some earlier, less formalized, model that likely varied across clinics (denoted here as early-FTIC). METHODS: This was a cost-outcome analysis using standard methods and a composite outcome defined as initiated antiretroviral therapy (ART) within 30 days of treatment eligibility and retained in care at 9 months. Using patient-level, bottom-up resource-utilization data and local unit costs, we estimated patient-level costs of care and treatment in 2017 U.S. dollars over the 9-month evaluation follow-up period for the two models of care. Resource use and costs, disaggregated by antiretroviral medications, laboratory tests, and clinic visits, are reported by model of care and stratified by the composite outcome. RESULTS: A total of 350/343 patients in the early-FTIC/AGL-FTIC models of care are included in this analysis. Mean/median costs were similar for both models of care ($135/$153 for early-FTIC, $130/$151 for AGL-FTIC). For the subset achieving the composite outcome, resource use and therefore mean/median costs were similar but slightly higher, reflecting care consistent with treatment guidelines ($163/$166 for early-FTIC, $168/$170 for AGL-FTIC). Not surprisingly, costs for patients not achieving the composite outcome were substantially less, mainly because they only had two or fewer follow-up visits and, therefore, received substantially less ART than patients who achieved the composite outcome. CONCLUSION: The 2016 adherence guidelines clarified expectations for the content and timing of adherence counseling sessions in relation to ART initiation. Because clinics were already initiating patients on ART quickly by 2016, little room existed for the new model of fast-track initiation counseling to reduce the number of pre-ART clinic visits at the study sites and therefore to reduce costs of care and treatment. TRIAL REGISTRATION: Clinical Trial Number: NCT02536768.

Will differentiated care for stable HIV patients reduce healthcare systems costs?

INTRODUCTION: South Africa's National Department of Health launched the National Adherence Guidelines for Chronic Diseases in 2015. These guidelines include adherence clubs (AC) and decentralized medication delivery (DMD) as two differentiated models of care for stable HIV patients on antiretroviral therapy. While the adherence guidelines do not suggest that provider costs (costs to the healthcare system for medications, laboratory tests and visits to clinics or alternative locations) for stable patients in these differentiated models of care will be lower than conventional, clinic-based care, recent modelling exercises suggest that such differentiated models could substantially reduce provider costs. In the context of continued implementation of the guidelines, we discuss the conditions under which provider costs of care for stable HIV patients could fall, or rise, with AC and DMD models of care in South Africa. DISCUSSION: In prior studies of HIV care and treatment costs, three main cost categories are antiretroviral medications, laboratory tests and general interaction costs based on encounters with health workers. Stable patients are likely to be on the national first-line regimen (Tenofovir/Entricitabine/Efavarinz (TDF/FTC/EFV)), so no difference in the costs of medications is expected. Laboratory testing guidelines for stable patients are the same regardless of the model of care, so no difference in laboratory costs is expected as well. Based on existing information regarding the costs of clinic visits, AC visits and DMD drug pickups, we expect that for some clinics, visit costs for DMD or AC models of care could be less, but modestly so, than for conventional, clinic-based care. For other clinics, however, DMD or AC models could have higher visit costs (see Table 2). CONCLUSIONS: The standard of care for stable patients has already been "differentiated" for years in South Africa, prior to the roll out of the new adherence guidelines. AC and DMD models of care, when implemented as envisioned in the guidelines, are unlikely to generate substantive reductions or increases in provider costs of care.

"Patients are not the same, so we cannot treat them the same" - A qualitative content analysis of provider, patient and implementer perspectives on differentiated service delivery models for HIV treatment in South Africa.

INTRODUCTION: In 2014, the South African government adopted a differentiated service delivery (DSD) model in its "National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)" (AGL) to strengthen the HIV care cascade. We describe the barriers and facilitators of the AGL implementation as experienced by various stakeholders in eight intervention and control sites across four districts. METHODS: Embedded within a cluster-randomized evaluation of the AGL, we conducted 48 in-depth interviews (IDIs) with healthcare providers, 16 IDIs with Department of Health and implementing partners and 24 focus group discussions (FGDs) with three HIV patient groups: new, stable and those not stable on treatment or not adhering to care. IDIs were conducted from August 2016 to August 2017; FGDs were conducted in January to February 2017. Content analysis was guided by the Consolidated Framework for Implementation Research. Findings were triangulated among respondent types to elicit barriers and facilitators to implementation. RESULTS: New HIV patients found counselling helpful but intervention respondents reported sub-optimal counselling and privacy concerns as barriers to initiation. Providers felt insufficiently trained for this intervention and were confused by the simultaneous rollout of the Universal Test and Treat strategy. For stable patients, repeat prescription collection strategies (RPCS) were generally well received. Patients and providers concurred that RPCS reduced congestion and waiting times at clinics. There was confusion though, among providers and implementers, around implementation of RPCS interventions. For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges. All providers faced difficulties accessing data and identifying patients in need of tracing. Congestion at clinics and staff attitude were perceived as barriers preventing patients returning to care. CONCLUSIONS: Implementation of DSD models at scale is complex but this evaluation identified several positive aspects of AGL implementation. The positive perception of RPCS interventions and challenges managing patients not stable on treatment aligned with results from the larger evaluation. While some implementation challenges may resolve with experience, ensuring providers and implementers have the necessary training, tools and resources to operationalize AGL effectively is critical to the overall success of South Africa's HIV control strategy.

Differentiated HIV care in South Africa: the effect of fast-track treatment initiation counselling on ART initiation and viral suppression as partial results of an impact evaluation on the impact of a package of services to improve HIV treatment adherence.

INTRODUCTION: In response to suboptimal adherence and retention, South Africa's National Department of Health developed and implemented National Adherence Guidelines for Chronic Diseases. We evaluated the effect of a package of adherence interventions beginning in January 2016 and report on the impact of Fast-Track Treatment Initiation Counselling (FTIC) on ART initiation, adherence and retention. METHODS: We conducted a cluster-randomized mixed-methods evaluation in 4 provinces at 12 intervention sites which implemented FTIC and 12 control facilities providing standard of care. Follow-up was by passive surveillance using clinical records. We included data on subjects eligible for FTIC between 08 Jan 2016 and 07 December 2016. We adjusted for pre-intervention differences using difference-in-differences (DiD) analyses controlling for site-level clustering. RESULTS: We enrolled 362 intervention and 368 control arm patients. Thirty-day ART initiation was 83% in the intervention and 82% in the control arm (RD 0.5%; 95% CI: -5.0% to 6.0%). After adjusting for baseline ART initiation differences and covariates using DiD we found a 6% increase in ART initiation associated with FTIC (RD 6.3%; 95% CI: -0.6% to 13.3%). We found a small decrease in viral suppression within 18 months (RD -2.8%; 95% CI: -9.8% to 4.2%) with no difference after adjustment (RD: -1.9%; 95% CI: -9.1% to 5.4%) or when considering only those with a viral load recorded (84% intervention vs. 86% control). We found reduced crude 6-month retention in intervention sites (RD -7.2%; 95% CI: -14.0% to -0.4%). However, differences attenuated by 12 months (RD: -3.6%; 95% CI: -11.1% to 3.9%). Qualitative data showed FTIC counselling was perceived as beneficial by patients and providers. CONCLUSIONS: We saw a short-term ART-initiation benefit to FTIC (particularly in districts where initiation prior to intervention was lower), with no reductions but also no improvement in longer-term retention and viral suppression. This may be due to lack of fidelity to implementation and delivery of those components that support retention and adherence. FTIC must continue to be implemented alongside other interventions to achieve the 90-90-90 cascade and fidelity to post-initiation counselling sessions must be monitored to determine impact on longer-term outcomes. Understanding the cost-benefit and role of FTIC may then be warranted.

CD4 count recovery and associated factors among individuals enrolled in the South African antiretroviral therapy programme: An analysis of national laboratory based data.

BACKGROUND: We describe CD4 count recovery among HIV positive individuals who initiated antiretroviral therapy (ART) with and without severe immune suppression using complete laboratory data from South Africa's national HIV treatment programme between 2010 and 2014 and discuss implications for CD4 count monitoring. METHODS: Retrospective analysis of routinely collected laboratory data from South Africa's National Health Laboratory Service (NHLS). A probabilistic record linkage algorithm was used to create a cohort of HIV positive individuals who initiated ART between 2010 and 2014 based on timing of CD4 count and viral load measurements. A CD4 count < 50 copies/µl at ART initiation was considered severe immunosuppression. A multivariable piecewise mixed-effects linear regression model adjusting for age, gender, year of starting ART, viral suppression in follow up and province was used to predict CD4 counts during follow up. RESULTS: 1,070,900 individuals had evidence of starting ART during 2010-2014 and met the criteria for inclusion in the cohort -46.6% starting ART with CD4 < 200 cells/µl and 10.1% with CD4 < 50 cells/ µl. For individuals with CD4 counts < 200 cells/µl, predicted CD4 counts > 200 cells/µl, >350 cells/µl and >500 cells/µl corresponded with mean follow up durations of 1.5 years (standard deviation [s.d] 1.1), 1.9years (s.d 1.2) and 2.1 years (s.d 1.3 years). For those with CD4 counts < 50 cells/µl, predicted CD4 count above these threshold corresponded with mean follow up durations of 2.5 years (s.d 0.9 years), 4.4 years (s.d 0.4 years) and 5.0 years (s.d 0.1years) for recovery to the same thresholds. CD4 count recovery varied mostly with duration on ART, CD4 count at the start of ART and gender. CONCLUSION: For individuals starting with ART with severe immunosuppression, CD4 recovery to 200cells/µl did not occur or took longer than 12 month for significant proportions. CD4 monitoring and interventions recommended for advanced HIV disease should continue until full recovery.