Recovery of Routine Immunisation: Mapping External Financing Opportunities for Reaching Zero-Dose Children.

The COVID-19 pandemic has precipitated large declines in childhood vaccination coverage and, consequently, substantial increases in the number of zero-dose children. To effectively respond to these declines, it is necessary to direct resources for recovery. We mapped active external financing for immunisation and primary healthcare in 20 countries with the highest numbers of zero-dose children to promote transparency and donor coordination. We found that countries have disparate access to external financing, with the two upper-middle-income countries (Brazil and Mexico) only having access to loans from the International Bank for Reconstruction and Development. Domestic resource mobilization is, therefore, key in these two countries, although fiscal space is likely constrained. Four additional countries (Angola, Indonesia, Philippines, and Vietnam) do not have allocations from Gavi, the Vaccine Alliance for Health Systems Strengthening, or Equity Accelerator Funding, but are eligible for support under Gavi's Middle-Income Countries Approach. Our methods, which focus on current donor financing, are novel and reveal substantial variations in access to external financing to support immunisation in high-burden countries. The available data differ considerably across financing mechanisms, making it difficult to synthesise the results across funding sources.

Does subsidizing the private for-profit sector benefit the poor? Evidence from national antimalarial subsidies in Nigeria and Uganda.

Subsidising quality-assured artemisinin combination therapies (QAACTs) for distribution in the for-profit sector is a controversial strategy for improving access. The Affordable Medicines Facility-malaria (AMFm) was the largest initiative of this kind. We assessed the equity of AMFm in two ways using nationally representative household survey data on care seeking for children from Nigeria and Uganda. First, the delivery of subsidized drugs through the for-profit sector via AMFm was compared with two alternative mechanisms: subsidized delivery in public health facilities and unsubsidized delivery in the for-profit sector. Second, we developed a novel extension of benefit incidence analysis (BIA) methods based on the concept of pass-through, and applied them to Uganda. In Nigeria, the use of subsidized QAACTs from both public health facilities and for-profit outlets was concentrated among the rich, while in Uganda, the use of QAACTs from both sources was concentrated among the poor. Similarly, the BIA of AMFm found that the intervention was pro-poor in Uganda. Unsubsidized antimalarials from for-profit outlets were distributed equally across wealth quintiles in both countries. Private sector subsidies may have a role in bolstering access to effective malaria treatments, including among the poor, but the equity impact of subsidies may depend on context.

An assessment of the malaria-related knowledge and practices of Tanzania's drug retailers: exploring the impact of drug store accreditation.

BACKGROUND: Since 2003 Tanzania has upgraded its approximately 7000 drug stores to Accredited Drug Dispensing Outlets (ADDOs), involving dispenser training, introduction of record keeping and enhanced regulation. Prior to accreditation, drug stores could officially stock over-the-counter medicines only, though many stocked prescription-only antimalarials. ADDOs are permitted to stock 49 prescription-only medicines, including artemisinin combination therapies and one form of quinine injectable. Oral artemisinin monotherapies and other injectables were not permitted at any time. By late 2011 conversion was complete in 14 of 21 regions. We explored variation in malaria-related knowledge and practices of drug retailers in ADDO and non-ADDO regions. METHODS: Data were collected as part of the Independent Evaluation of the Affordable Medicines Facility - malaria (AMFm), involving a nationally representative survey of antimalarial retailers in October-December 2011. We randomly selected 49 wards and interviewed all drug stores stocking antimalarials. We compare ADDO and non-ADDO regions, excluding the largest city, Dar es Salaam, due to the unique characteristics of its market. RESULTS: Interviews were conducted in 133 drug stores in ADDO regions and 119 in non-ADDO regions. Staff qualifications were very similar in both areas. There was no significant difference in the availability of the first line antimalarial (68.9% in ADDO regions and 65.2% in non-ADDO regions); both areas had over 98% availability of non-artemisinin therapies and below 3.0% of artemisinin monotherapies. Staff in ADDO regions had better knowledge of the first line antimalarial than non-ADDO regions (99.5% and 91.5%, p = 0.001). There was weak evidence of a lower price and higher market share of the first line antimalarial in ADDO regions. Drug stores in ADDO regions were more likely to stock ADDO-certified injectables than those in non-ADDO regions (23.0% and 3.9%, p = 0.005). CONCLUSIONS: ADDO conversion is frequently cited as a model for improving retail sector drug provision. Drug stores in ADDO regions performed better on some indicators, possibly indicating some small benefits from ADDO conversion, but also weaknesses in ADDO regulation and high staff turnover. More evidence is needed on the value-added and value for money of the ADDO roll out to inform retail policy in Tanzania and elsewhere.

Effect and cost-effectiveness of educating mothers about childhood DPT vaccination on immunisation uptake, knowledge, and perceptions in Uttar Pradesh, India: A randomised controlled trial.

BACKGROUND: To assess the effect of health information on immunisation uptake in rural India, we conducted an individually randomised controlled trial of health information messages targeting the mothers of unvaccinated or incompletely vaccinated children through home visits in rural Uttar Pradesh, India. METHODS AND FINDINGS: The study tested a brief intervention that provided mothers face-to-face with information on the benefits of the tetanus vaccine. Participants were 722 mothers of children aged 0-36 months who had not received 3 doses of diphtheria-pertussis-tetanus (DPT) vaccine (DPT3). Mothers were randomly assigned in a ratio of 1:1:1 to 1 of 3 study arms: mothers in the first treatment group received information framed as a gain (e.g., the child is less likely to get tetanus and more likely to be healthy if vaccinated), mothers in the second treatment group received information framed in terms of a loss (e.g., the child is more likely to get tetanus and suffer ill health if not vaccinated), and the third arm acted as a control group, with no information given to the mother. Surveys were conducted at baseline (September 2015) and after the intervention (April 2016). The primary outcome was the proportion of children who had received DPT3 measured after 7 months of follow-up. The analysis was by intention to treat. A total of 16 (2.2%) participants were lost to follow-up. The coverage of DPT3 was 28% in the control group and 43% in the pooled information groups, giving a risk difference of 15 percentage points (95% CI: 7% to 22%, p < 0.001) and a relative risk of 1.52 (95% CI: 1.2 to 1.9, p < 0.001). The information intervention increased the rate of measles vaccination by 22 percentage points (risk difference: 22%, 95% CI: 14% to 30%, p < 0.001; relative risk: 1.53, 95% CI: 1.29 to 1.80) and the rate of full immunisation by 14 percentage points (risk difference: 14%, 95% CI: 8% to 21%, p < 0.001; relative risk: 1.72, 95% CI: 1.29 to 2.29). It had a large positive effect on knowledge of the causes, symptoms, and prevention of tetanus but no effect on perceptions of vaccine efficacy. There was no difference in the proportion of children with DPT3 between the group that received information framed as a loss and the group that received information framed as a gain (risk difference: 4%, 95% CI: -5% to 13%; p = 0.352; relative risk: 1.11, 95% CI: 0.90 to 1.36). The cost per disability-adjusted life year averted of providing information was US$186, making the intervention highly cost-effective with respect to the WHO-recommended threshold of once the gross domestic product per capita (US$793 in the case of Uttar Pradesh). Key study limitations include the modest sample size for this trial, limiting power to detect small differences in the framing of information, and the potential for contamination among households. CONCLUSIONS: Providing mothers of unvaccinated/incompletely vaccinated children with information on tetanus and the benefits of DPT vaccination substantially increased immunisation coverage and was highly cost-effective. The framing of the health information message did not appear to matter. TRIAL REGISTRATION: The trial is registered with ISRCTN, number ISRCTN84560580.

Effect of a multifaceted social franchising model on quality and coverage of maternal, newborn, and reproductive health-care services in Uttar Pradesh, India: a quasi-experimental study.

BACKGROUND: How to harness the private sector to improve population health in low-income and middle-income countries is heavily debated and one prominent strategy is social franchising. We aimed to evaluate whether the Matrika social franchising model-a multifaceted intervention that established a network of private providers and strengthened the skills of both public and private sector clinicians-could improve the quality and coverage of health services along the continuum of care for maternal, newborn, and reproductive health. METHODS: We did a quasi-experimental study, which combined matching with difference-in-differences methods. We matched 60 intervention clusters (wards or villages) with a social franchisee to 120 comparison clusters in six districts of Uttar Pradesh, India. The intervention was implemented by two not-for-profit organisations from September, 2013, to May, 2016. We did two rounds (January, 2015, and May, 2016) of a household survey for women who had given birth up to 2 years previously. The primary outcome was the proportion of women who gave birth in a health-care facility. An additional 56 prespecified outcomes measured maternal health-care use, content of care, patient experience, and other dimensions of care. We organised conceptually similar outcomes into 14 families to create summary indices. We used multivariate difference-in-differences methods for the analyses and accounted for multiple inference. FINDINGS: The introduction of Matrika was not significantly associated with the change in facility births (4 percentage points, 95% CI -1 to 9; p=0·100). Effects for any of the other individual outcomes or for any of the 14 summary indices were not significant. Evidence was weak for an increase of 0·13 SD (95% CI 0·00 to 0·27; p=0·053) in recommended delivery care practices. INTERPRETATION: The Matrika social franchise model was not effective in improving the quality and coverage of maternal health services at the population level. Several key reasons identified for the absence of an effect potentially provide generalisable lessons for social franchising programmes elsewhere. FUNDING: Merck Sharp and Dohme Limited.

What happened to anti-malarial markets after the Affordable Medicines Facility-malaria pilot? Trends in ACT availability, price and market share from five African countries under continuation of the private sector co-payment mechanism.

BACKGROUND: The private sector supplies anti-malarial treatment for large proportions of patients in sub-Saharan Africa. Following the large-scale piloting of the Affordable Medicines Facility-malaria (AMFm) from 2010 to 2011, a private sector co-payment mechanism (CPM) provided continuation of private sector subsidies for quality-assured artemisinin combination therapies (QAACT). This article analyses for the first time the extent to which improvements in private sector QAACT supply and distribution observed during the AMFm were maintained or intensified during continuation of the CPM through 2015 in Kenya, Madagascar, Nigeria, Tanzania and Uganda using repeat cross-sectional outlet survey data. RESULTS: QAACT market share in all five countries increased during the AMFm period (p < 0.001). According to the data from the last ACTwatch survey round, in all study countries except Madagascar, AMFm levels of private sector QAACT availability were maintained or improved. In 2014/15, private sector QAACT availability was greater than 70% in Nigeria (84.3%), Kenya (70.5%), Tanzania (83.0%) and Uganda (77.1%), but only 11.2% in Madagascar. QAACT market share was maintained or improved post-AMFm in Nigeria, Tanzania and Uganda, but statistically significant declines were observed in Kenya and Madagascar. In 2014/5, QAACT market share was highest in Kenya and Uganda (48.2 and 47.5%, respectively) followed by Tanzania (39.2%), Nigeria (35.0%), and Madagascar (7.0%). Four of the five countries experienced significant decreases in median QAACT price during the AMFm period. Private sector QAACT prices were maintained or further reduced in Tanzania, Nigeria and Uganda, but prices increased significantly in Kenya and Madagascar. SP prices were consistently lower than those of QAACT in the AMFm period, with the exception of Kenya and Tanzania in 2011, where they were equal. In 2014/5 QAACT remained two to three times more expensive than the most popular non-artemisinin therapy in all countries except Tanzania. CONCLUSIONS: Results suggest that a private sector co-payment mechanism for QAACT implemented at national scale for 5 years was associated with positive and sustained improvements in QAACT availability, price and market share in Nigeria, Tanzania and Uganda, with more mixed results in Kenya, and few improvements in Madagascar. The subsidy mechanism as implemented over time across countries was not sufficient on its own to achieve optimal QAACT uptake. Supporting interventions to address continued availability and distribution of non-artemisinin therapies, and to create demand for QAACT among providers and consumers need to be effectively implemented to realize the full potential of this subsidy mechanism. Furthermore, there is need for comprehensive market assessments to identify contemporary market barriers to high coverage with both confirmatory testing and appropriate treatment.

Cash transfers, maternal depression and emotional well-being: Quasi-experimental evidence from India's Janani Suraksha Yojana programme.

Maternal depression is an important public health concern. We investigated whether a national-scale initiative that provides cash transfers to women giving birth in government health facilities, the Janani Suraksha Yojana (JSY), reduced maternal depression in India's largest state, Uttar Pradesh. Using primary data on 1695 women collected in early 2015, our quasi-experimental design exploited the fact that some women did not receive the JSY cash due to administrative problems in its disbursement - reasons that are unlikely to be correlated with determinants of maternal depression. We found that receipt of the cash was associated with an 8.5% reduction in the continuous measure of maternal depression and a 36% reduction in moderate depression. There was no evidence of an association with measures of emotional well-being, namely happiness and worry. The results suggest that the JSY had a clinically meaningful effect in reducing the burden of maternal depression, possibly by lessening the financial strain of delivery care. They contribute to the evidence that financial incentive schemes may have public health benefits beyond improving uptake of targeted health services.

Prices and mark-ups on antimalarials: evidence from nationally representative studies in six malaria-endemic countries.

The private for-profit sector is an important source of treatment for malaria. However, private patients face high prices for the recommended treatment for uncomplicated malaria, artemisinin combination therapies (ACTs), which makes them more likely to receive cheaper, less effective non-artemisinin therapies (nATs). This study seeks to better understand consumer antimalarial prices by documenting and exploring the pricing behaviour of retailers and wholesalers. Using data collected in 2009-10, we present survey estimates of antimalarial retail prices, and wholesale- and retail-level price mark-ups from six countries (Benin, Cambodia, the Democratic Republic of Congo, Nigeria, Uganda and Zambia), along with qualitative findings on factors affecting pricing decisions. Retail prices were lowest for nATs, followed by ACTs and artemisinin monotherapies (AMTs). Retailers applied the highest percentage mark-ups on nATs (range: 40% in Nigeria to 100% in Cambodia and Zambia), whereas mark-ups on ACTs (range: 22% in Nigeria to 71% in Zambia) and AMTs (range: 22% in Nigeria to 50% in Uganda) were similar in magnitude, but lower than those applied to nATs. Wholesale mark-ups were generally lower than those at retail level, and were similar across antimalarial categories in most countries. When setting prices wholesalers and retailers commonly considered supplier prices, prevailing market prices, product availability, product characteristics and the costs related to transporting goods, staff salaries and maintaining a property. Price discounts were regularly used to encourage sales and were sometimes used by wholesalers to reward long-term customers. Pricing constraints existed only in Benin where wholesaler and retailer mark-ups are regulated; however, unlicensed drug vendors based in open-air markets did not adhere to the pricing regime. These findings indicate that mark-ups on antimalarials are reasonable. Therefore, improving ACT affordability would be most readily achieved by interventions that reduce commodity prices for retailers, such as ACT subsidies, pooled purchasing mechanisms and cost-effective strategies to increase the distribution coverage area of wholesalers.

Determinants of price setting decisions on anti-malarial drugs at retail shops in Cambodia.

BACKGROUND: In many low-income countries, the private commercial sector plays an important role in the provision of malaria treatment. However, the quality of care it provides is often poor, with artemisinin combination therapy (ACT) generally being too costly for consumers. Decreasing ACT prices is critical for improving private sector treatment outcomes and reducing the spread of artemisinin resistance. Yet limited evidence exists on the factors influencing retailers' pricing decisions. This study investigates the determinants of price mark-ups on anti-malarial drugs in retail outlets in Cambodia. METHODS: Taking an economics perspective, the study tests the hypothesis that the structure of the anti-malarial market determines the way providers set their prices. Providers facing weak competition are hypothesized to apply high mark-ups and set prices above the competitive level. To analyse the relationship between market competition and provider pricing, the study used cross-sectional data from retail outlets selling anti-malarial drugs, including outlet characteristics data (e.g. outlet type, anti-malarial sales volumes), range of anti-malarial drugs stocked (e.g. dosage form, brand status) and purchase and selling prices. Market concentration, a measure of the level of market competition, was estimated using sales volume data. Market accessibility was defined based on travel time to the closest main commercial area. Percent mark-ups were calculated using price data. The relationship between mark-ups and market concentration was explored using regression analysis. RESULTS: The anti-malarial market was on average highly concentrated, suggesting weak competition. Higher concentration was positively associated with higher mark-ups in moderately accessible markets only, with no significant relationship or a negative relationship in other markets. Other determinants of pricing included anti-malarial brand status and generic type, with higher mark-ups on cheaper products. CONCLUSIONS: The results indicate that provider pricing as well as other key elements of anti-malarial supply and demand may have played an important role in the limited access to appropriate malaria treatment in Cambodia. The potential for an ACT price subsidy at manufacturer level combined with effective communications directed at consumers and supportive private sector regulation should be explored to improve access to quality malaria treatment in Cambodia.

Availability and price of malaria rapid diagnostic tests in the public and private health sectors in 2011: results from 10 nationally representative cross-sectional retail surveys.

OBJECTIVES: To describe the state of the public and private malaria diagnostics market shortly after WHO updated its guidelines for testing all suspected malaria cases prior to treatment. METHODS: Ten nationally representative cross-sectional cluster surveys were conducted in 2011 among public and private health facilities, community health workers and retail outlets (pharmacies and drug shops) in nine countries (Tanzania mainland and Zanzibar surveyed separately). Eligible outlets had antimalarials in stock on the day of interview or had stocked antimalarials in the past 3 months. RESULTS: Three thousand four hundred and thirty-nine rapid diagnostic test (RDT) products from 39 manufacturers were audited among 12,197 outlets interviewed. Availability was typically highest in public health facilities, although availability in these facilities varied greatly across countries, from 15% in Nigeria to >90% in Madagascar and Cambodia. Private for-profit sector availability was 46% in Cambodia, 20% in Zambia, but low in other countries. Median retail prices for RDTs in the private for-profit sector ranged from $0.00 in Madagascar to $3.13 in Zambia. The reported number of RDTs used in the 7 days before the survey in public health facilities ranged from 3 (Benin) to 50 (Zambia). CONCLUSIONS: Eighteen months after WHO updated its case management guidelines, RDT availability remained poor in the private sector in sub-Saharan Africa. Given the ongoing importance of the private sector as a source of fever treatment, the goal of universal diagnosis will not be achievable under current circumstances. These results constitute national baselines against which progress in scaling-up diagnostic tests can be assessed.

Improving access to malaria medicine through private-sector subsidies in seven African countries.

Improving access to quality-assured artemisinin combination therapies (ACTs) is an important component of malaria control in low- and middle-income countries. In 2010 the Global Fund to Fight AIDS, Tuberculosis, and Malaria launched the Affordable Medicines Facility--malaria (AMFm) program in seven African countries. The goal of the program was to decrease malaria morbidity and delay drug resistance by increasing the use of ACTs, primarily through subsidies intended to reduce costs. We collected data on price and retail markups on antimalarial medicines from 19,625 private for-profit retail outlets before and 6-15 months after the program's implementation. We found that in six of the AMFm pilot programs, prices for quality-assured ACTs decreased by US$1.28-$4.34, and absolute retail markups on these therapies decreased by US$0.31-$1.03. Prices and markups on other classes of antimalarials also changed during the evaluation period, but not to the same extent. In all but two of the pilot programs, we found evidence that prices could fall further without suppliers' losing money. Thus, concerns may be warranted that wholesalers and retailers are capturing subsidies instead of passing them on to consumers. These findings demonstrate that supranational subsidies can dramatically reduce retail prices of health commodities and that recommended retail prices communicated to a wide audience may be an effective mechanism for controlling the market power of private-sector antimalarial retailers and wholesalers.

Has Tanzania embraced the green leaf? Results from outlet and household surveys before and after implementation of the Affordable Medicines Facility-malaria.

BACKGROUND: The Affordable Medicines Facility-malaria (AMFm) is primarily an artemisinin combination therapy (ACT) subsidy, aimed at increasing availability, affordability, market share and use of quality-assured ACTs (QAACTs). Mainland Tanzania was one of eight national scale programmes where AMFm was introduced in 2010. Here we present findings from outlet and household surveys before and after AMFm implementation to evaluate its impact from both the supply and demand side. METHODS: Outlet surveys were conducted in 49 randomly selected wards throughout mainland Tanzania in 2010 and 2011, and data on outlet characteristics and stocking patterns were collected from outlets stocking antimalarials. Household surveys were conducted in 240 randomly selected enumeration areas in three regions in 2010 and 2012. Questions about treatment seeking for fever and drugs obtained were asked of individuals reporting fever in the previous two weeks. RESULTS: The availability of QAACTs increased from 25.5% to 69.5% among all outlet types, with the greatest increase among pharmacies and drug stores, together termed specialised drug sellers (SDSs), where the median QAACT price fell from $5.63 to $0.94. The market share of QAACTs increased from 26.2% to 42.2%, again with the greatest increase in SDSs. Household survey results showed a shift in treatment seeking away from the public sector towards SDSs. Overall, there was no change in the proportion of people with fever obtaining an antimalarial or ACT from baseline to endline. However, when broken down by treatment source, ACT use increased significantly among clients visiting SDSs. DISCUSSION: Unchanged ACT use overall, despite increases in QAACT availability, affordability and market share in the private sector, reflected a shift in treatment seeking towards private providers. The reasons for this shift are unclear, but likely reflect both persistent stockouts in public facilities, and the increased availability of subsidised ACTs in the private sector.

Understanding private sector antimalarial distribution chains: a cross-sectional mixed methods study in six malaria-endemic countries.

BACKGROUND: Private for-profit outlets are important treatment sources for malaria in most endemic countries. However, these outlets constitute only the last link in a chain of businesses that includes manufacturers, importers and wholesalers, all of which influence the availability, price and quality of antimalarials patients can access. We present evidence on the composition, characteristics and operation of these distribution chains and of the businesses that comprise them in six endemic countries (Benin, Cambodia, Democratic Republic of Congo, Nigeria, Uganda and Zambia). METHODS AND FINDINGS: We conducted nationally representative surveys of antimalarial wholesalers during 2009-2010 using an innovative sampling approach that captured registered and unregistered distribution channels, complemented by in-depth interviews with a range of stakeholders. Antimalarial distribution chains were pyramidal in shape, with antimalarials passing through a maximum of 4-6 steps between manufacturer and retailer; however, most likely pass through 2-3 steps. Less efficacious non-artemisinin therapies (e.g. chloroquine) dominated weekly sales volumes among African wholesalers, while volumes for more efficacious artemisinin-based combination therapies (ACTs) were many times smaller. ACT sales predominated only in Cambodia. In all countries, consumer demand was the principal consideration when selecting products to stock. Selling prices and reputation were key considerations regarding supplier choice. Business practices varied across countries, with large differences in the proportions of wholesalers offering credit and delivery services to customers, and the types of distribution models adopted by businesses. Regulatory compliance also varied across countries, particularly with respect to licensing. The proportion of wholesalers possessing any up-to-date licence from national regulators was lowest in Benin and Nigeria, where vendors in traditional markets are important antimalarial supply sources. CONCLUSIONS: The structure and characteristics of antimalarial distribution chains vary across countries; therefore, understanding the wholesalers that comprise them should inform efforts aiming to improve access to quality treatment through the private sector.

Communicating the AMFm message: exploring the effect of communication and training interventions on private for-profit provider awareness and knowledge related to a multi-country anti-malarial subsidy intervention.

BACKGROUND: The Affordable Medicines Facility - malaria (AMFm), implemented at national scale in eight African countries or territories, subsidized quality-assured artemisinin combination therapy (ACT) and included communication campaigns to support implementation and promote appropriate anti-malarial use. This paper reports private for-profit provider awareness of key features of the AMFm programme, and changes in provider knowledge of appropriate malaria treatment. METHODS: This study had a non-experimental design based on nationally representative surveys of outlets stocking anti-malarials before (2009/10) and after (2011) the AMFm roll-out. RESULTS: Based on data from over 19,500 outlets, results show that in four of eight settings, where communication campaigns were implemented for 5-9 months, 76%-94% awareness of the AMFm 'green leaf' logo, 57%-74% awareness of the ACT subsidy programme, and 52%-80% awareness of the correct recommended retail price (RRP) of subsidized ACT were recorded. However, in the remaining four settings where communication campaigns were implemented for three months or less, levels were substantially lower. In six of eight settings, increases of at least 10 percentage points in private for-profit providers' knowledge of the correct first-line treatment for uncomplicated malaria were seen; and in three of these the levels of knowledge achieved at endline were over 80%. CONCLUSIONS: The results support the interpretation that, in addition to the availability of subsidized ACT, the intensity of communication campaigns may have contributed to the reported levels of AMFm-related awareness and knowledge among private for-profit providers. Future subsidy programmes for anti-malarials or other treatments should similarly include communication activities.

Comparative analysis of two methods for measuring sales volumes during malaria medicine outlet surveys.

BACKGROUND: There is increased interest in using commercial providers for improving access to quality malaria treatment. Understanding their current role is an essential first step, notably in terms of the volume of diagnostics and anti-malarials they sell. Sales volume data can be used to measure the importance of different provider and product types, frequency of parasitological diagnosis and impact of interventions. Several methods for measuring sales volumes are available, yet all have methodological challenges and evidence is lacking on the comparability of different methods. METHODS: Using sales volume data on anti-malarials and rapid diagnostic tests (RDTs) for malaria collected through provider recall (RC) and retail audits (RA), this study measures the degree of agreement between the two methods at wholesale and retail commercial providers in Cambodia following the Bland-Altman approach. Relative strengths and weaknesses of the methods were also investigated through qualitative research with fieldworkers. RESULTS: A total of 67 wholesalers and 107 retailers were sampled. Wholesale sales volumes were estimated through both methods for 62 anti-malarials and 23 RDTs and retail volumes for 113 anti-malarials and 33 RDTs. At wholesale outlets, RA estimates for anti-malarial sales were on average higher than RC estimates (mean difference of four adult equivalent treatment doses (95% CI 0.6-7.2)), equivalent to 30% of mean sales volumes. For RDTs at wholesalers, the between-method mean difference was not statistically significant (one test, 95% CI -6.0-4.0). At retail outlets, between-method differences for both anti-malarials and RDTs increased with larger volumes being measured, so mean differences were not a meaningful measure of agreement between the methods. Qualitative research revealed that in Cambodia where sales volumes are small, RC had key advantages: providers were perceived to remember more easily their sales volumes and find RC less invasive; fieldworkers found it more convenient; and it was cheaper to implement than RA. DISCUSSION/CONCLUSIONS: Both RA and RC had implementation challenges and were prone to data collection errors. Choice of empirical methods is likely to have important implications for data quality depending on the study context.

Effect of the Affordable Medicines Facility--malaria (AMFm) on the availability, price, and market share of quality-assured artemisinin-based combination therapies in seven countries: a before-and-after analysis of outlet survey data.

BACKGROUND: Malaria is one of the greatest causes of mortality worldwide. Use of the most effective treatments for malaria remains inadequate for those in need, and there is concern over the emergence of resistance to these treatments. In 2010, the Global Fund launched the Affordable Medicines Facility--malaria (AMFm), a series of national-scale pilot programmes designed to increase the access and use of quality-assured artemisinin based combination therapies (QAACTs) and reduce that of artemisinin monotherapies for treatment of malaria. AMFm involves manufacturer price negotiations, subsidies on the manufacturer price of each treatment purchased, and supporting interventions such as communications campaigns. We present findings on the effect of AMFm on QAACT price, availability, and market share, 6-15 months after the delivery of subsidised ACTs in Ghana, Kenya, Madagascar, Niger, Nigeria, Uganda, and Tanzania (including Zanzibar). METHODS: We did nationally representative baseline and endpoint surveys of public and private sector outlets that stock antimalarial treatments. QAACTs were identified on the basis of the Global Fund's quality assurance policy. Changes in availability, price, and market share were assessed against specified success benchmarks for 1 year of AMFm implementation. Key informant interviews and document reviews recorded contextual factors and the implementation process. FINDINGS: In all pilots except Niger and Madagascar, there were large increases in QAACT availability (25·8-51·9 percentage points), and market share (15·9-40·3 percentage points), driven mainly by changes in the private for-profit sector. Large falls in median price for QAACTs per adult equivalent dose were seen in the private for-profit sector in six pilots, ranging from US$1·28 to $4·82. The market share of oral artemisinin monotherapies decreased in Nigeria and Zanzibar, the two pilots where it was more than 5% at baseline. INTERPRETATION: Subsidies combined with supporting interventions can be effective in rapidly improving availability, price, and market share of QAACTs, particularly in the private for-profit sector. Decisions about the future of AMFm should also consider the effect on use in vulnerable populations, access to malaria diagnostics, and cost-effectiveness. FUNDING: The Global Fund to Fight AIDS, Tuberculosis and Malaria, and the Bill & Melinda Gates Foundation.