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Additional file 5: Supplementary Annex 5. Menstrual monitoring consent form in English.

Additional file 3: Supplementary Annex 3. Menstrual monitoring participant information sheet in English.

Additional file 1: Supplementary Annex 1. Trial Steering Monitoring (TSC) charter.

Additional file 8: Supplementary Annex 8. Data Monitoring Committee (DMC) charter.

Additional file 4: Supplementary Annex 4. Full Trial participant information sheets in English.

Additional file 7: Supplementary Annex 7. Expected pregnancies to be enrolled and numbers after loss to follow-up.

Additional file 6: Supplementary Annex 6. Full Trial consent form in English.

Additional file 2: Supplementary Annex 2. List of selected study clusters with population and expected pregnancies.

The country of Zimbabwe has seen some important improvements in key health outcomes since 2009. However, despite progress in some areas of the health sector, the country did not meet its Millennium Development Goals (MDGs) and current progress falls short of the Sustainable Development Goals (SDGs) milestones. As is often the case, the poor and rural populations in Zimbabwe bear a disproportionate burden of disease and health risks. The situation is compounded by national economic challenges and health sector spending inefficiencies that have resulted in households bearing an increasing share of health sector financing, mainly through out-of-pocket expenditures. Households provide approximately 25 percent of health sector financing in Zimbabwe. Again, the poor and rural populations are hardest hit by this economic reality. Zimbabwe was one of the few countries in which HIPtool was piloted at the proof of concept stage. HIPtool enables the mathematical prioritization of interventions based on existing data and a set of criteria. It provides a technical foundation to further develop an essential health benefits package. However, HIPtool, at this stage in development, still has strong limitations, which are outlined along with results in this report.

Afya secondary data. Information collected on all women who make facility visits in Siaya County, Kenya. (DOCX 36 kb)

Annex 11a: Participantâ s information sheet part 1, English. (DOCX 14 kb)

Rewarded health visits in the Afya project. (DOCX 27 kb)

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist: recommended items to address in a clinical trial protocol and related documents*. (DOC 122 kb)

BACKGROUND: The role of antiretroviral treatment for adults in the pubic sector in South Africa is debated with little consideration of programme choices that could impact on the cost-effectiveness of the intervention. This study seeks to explore the impact of these programme choices at an individual level, as well as explore the total cost of a rationed national public sector antiretroviral treatment programme. METHODS: Eight scenarios were modelled of limited national treatment programmes over the next 5 years, reflecting different programme design choices. The individual cost-effectiveness of these scenarios were compared. The total costs of the most cost-effective scenario were calculated, and the potential for savings in other areas of health care utilisation was explored. RESULTS: The direct programme costs per life-year saved varied between scenarios from R5,923 to R11,829. All the costs of the most cost-effective scenario could potentially be offset depending on assumptions of health care access and utilisation. The total programme costs for the most cost-effective scenario in 2007 with 107,000 people on treatment are around R409 million. CONCLUSION: Specific policy choices could almost double the number of people who could benefit from an investment in a limited national antiretroviral treatment programme. Such a programme is affordable within current resource constraints. The consideration of antiretroviral treatment calls for a unique public health approach to the rationing of health services in the public sector.

Health economics has expanded enormously as a sub-discipline in the last four decades, drawing primarily on the theoretical foundations of welfare economics. The toolkit for the economic evaluation of health care now extends from the humble cost-minimisation exercise, through cost effectiveness measures, to the more complex cost utility or cost benefit models. These methodologies have differing strengths and drawbacks. This paper evaluates those attributes on both the practical and theoretical dimensions. On the practical dimension: The developing country context differs from the wealthier country context in a number of ways. This paper considers the differences in resource constraints and the differences in health priorities and asks to what extent the methodology is able to accommodate these variations. On the theoretical dimension: Few health care evaluations are conducted in a Pareto Optimal world. This paper considers the extent to which the welfare economic foundations of a methodology are successfully imported into its construction, and then how that foundation translates into its practical application.

It is estimated that each HIV-positive child in South Africa costs the government more in terms of health and welfare expenses than it does to reduce mother-to-child transmission (MTCT) of HIV through the use of antiretroviral regimens (where the mother continues to breast-feed). Programmes to reduce MTCT of HIV/AIDS are, thus, clearly affordable. Using Nevirapine (according to the HIVNET 012 Protocol) saves fewer lives, but is more cost-effective than using Zidovudine (CDC 2 weeks regime).

INTRODUCTION With limited funds available, meeting global health targets requires countries to both mobilize and prioritize their health spending. Within this context, countries have recognized the importance of allocating funds for HIV as efficiently as possible to maximize impact. Over the past six years, the governments of 23 countries in Africa, Asia, Eastern Europe and Latin America have used the Optima HIV tool to estimate the optimal allocation of HIV resources. METHODS Each study commenced with a request by the national government for technical assistance in conducting an HIV allocative efficiency study using Optima HIV. Each study team validated the required data, calibrated the Optima HIV epidemic model to produce HIV epidemic projections, agreed on cost functions for interventions, and used the model to calculate the optimal allocation of available funds to best address national strategic plan targets. From a review and analysis of these 23 country studies, we extract common themes around the optimal allocation of HIV funding in different epidemiological contexts. RESULTS AND DISCUSSION The optimal distribution of HIV resources depends on the amount of funding available and the characteristics of each country's epidemic, response and targets. Universally, the modelling results indicated that scaling up treatment coverage is an efficient use of resources. There is scope for efficiency gains by targeting the HIV response towards the populations and geographical regions where HIV incidence is highest. Across a range of countries, the model results indicate that a more efficient allocation of HIV resources could reduce cumulative new HIV infections by an average of 18% over the years to 2020 and 25% over the years to 2030, along with an approximately 25% reduction in deaths for both timelines. However, in most countries this would still not be sufficient to meet the targets of the national strategic plan, with modelling results indicating that budget increases of up to 185% would be required. CONCLUSIONS Greater epidemiological impact would be possible through better targeting of existing resources, but additional resources would still be required to meet targets. Allocative efficiency models have proven valuable in improving the HIV planning and budgeting process.