Opening the policy blackbox: unravelling the process for changing national diagnostic and treatment guidelines for vivax malaria in seven countries.

BACKGROUND: The changing global health landscape has highlighted the need for more proactive, efficient and transparent health policy-making. After more than 60 years of limited development, novel tools for vivax malaria are finally available, but need to be integrated into national policies. This paper maps the malaria policy-making processes in seven endemic countries, to identify areas where it can be improved to align with best practices and optimal efficiency. METHODS: Data were collected during a workshop, convened by the Asia Pacific Malaria Elimination Network's Vivax Working Group in 2019, and subsequent interviews with key stakeholders from Cambodia, Ethiopia, Indonesia, Pakistan, Papua New Guinea (PNG), Sri Lanka and Vietnam. Documentation of policy processes provided by respondents was reviewed. Data analysis was guided by an analytic framework focused on three a priori defined domains: "context," "actors" and "processes". RESULTS: The context of policy-making varied with available funding for malaria, population size, socio-economic status, and governance systems. There was limited documentation of the process itself or terms of reference for involved actors. In all countries, the NMP plays a critical role in initiating and informing policy change, but the involvement of other actors varied considerably. Available evidence was described as a key influencer of policy change; however, the importance of local evidence and the World Health Organization's endorsement of new treatments and diagnostics varied. The policy process itself and its complexity varied but was mostly semi-siloed from other disease specific policy processes in the wider Ministry of Health. Time taken to change and introduce a new policy guideline previously varied from 3 months to 3 years. CONCLUSIONS: In the medium to long term, a better alignment of anti-malarial policy-making processes with the overall health policy-making would strengthen health governance. In the immediate term, shortening the timelines for policy change will be pivotal to meet proposed malaria elimination milestones.

Competing interests, clashing ideas and institutionalizing influence: insights into the political economy of malaria control from seven African countries.

This article explores how malaria control in sub-Saharan Africa is shaped in important ways by political and economic considerations within the contexts of aid-recipient nations and the global health community. Malaria control is often assumed to be a technically driven exercise: the remit of public health experts and epidemiologists who utilize available data to select the most effective package of activities given available resources. Yet research conducted with national and international stakeholders shows how the realities of malaria control decision-making are often more nuanced. Hegemonic ideas and interests of global actors, as well as the national and global institutional arrangements through which malaria control is funded and implemented, can all influence how national actors respond to malaria. Results from qualitative interviews in seven malaria-endemic countries indicate that malaria decision-making is constrained or directed by multiple competing objectives, including a need to balance overarching global goals with local realities, as well as a need for National Malaria Control Programmes to manage and coordinate a range of non-state stakeholders who may divide up regions and tasks within countries. Finally, beyond the influence that political and economic concerns have over programmatic decisions and action, our analysis further finds that malaria control efforts have institutionalized systems, structures and processes that may have implications for local capacity development.

Evaluation of Senegal supply chain intervention on contraceptive stockouts using routine stock data.

BACKGROUND: Until 2011, stockouts of family planning commodities were common in Senegalese public health facilities. Recognizing the importance of addressing this problem, the Government of Senegal implemented the Informed Push Model (IPM) supply system, which involves logisticians to collect facility-level stock turnover data once a month and provide contraceptive supplies accordingly. The aims of this paper were to evaluate the impact of IPM on contraceptive availability and on stockout duration. METHODS AND FINDINGS: To estimate the impact of the IPM on contraceptive availability, stock card data were obtained from health facilities selected through multistage sampling. A total number of 103 health facilities pertaining to 27 districts and nine regions across the country participated in this project. We compared the odds of contraceptive stockouts within the health facilities on the 23 months after the intervention with the 18 months before. The analysis was performed with a logistic model of the monthly time-series. The odds of stockout for any of the five contraceptive products decreased during the 23 months post-intervention compared to the 18 months pre-intervention (odds ratio, 95%CI: 0.34, 0.22-0.51). To evaluate the impact of the IPM on duration of stockouts, a mixed negative binomial zero-truncated regression analysis was performed. The IPM was not effective in reducing the duration of contraceptive stockouts (incidence rate ratio, 95%CI: 0.81, 0.24-2.7), except for the two long-acting contraceptives (intrauterine devices and implants). Our model predicted a decrease in stockout median duration from 23 pre- to 4 days post-intervention for intrauterine devices; and from 19 to 14 days for implants. CONCLUSIONS: We conclude that the IPM has resulted in greater efficiency in contraceptive stock management, increasing the availability of contraceptive methods in health facilities in Senegal. The IPM also resulted in decreased duration of stockouts for intrauterine devices and implants, but not for any of the short-acting contraception (pills and injectables).

Impact of internal female migration on unmet need for modern contraception in Zambia.

BACKGROUND: Unmet need for contraception, the proportion of women who want to limit or delay childbirth but use no form of contraception, is the core indicator to evaluate the effectiveness of family planning programs. Understanding how migration influences unmet need is important to identify to whom and how to target sexual and reproductive health programs. We assessed how migration status in rural and urban settings is associated with having an unmet need for family planning. METHODS: Data on sexually active, fecund, reproductive-aged (15-49 years) women from the 2013-14 Zambia Demographic and Health Survey were analysed through univariate and multivariate logistic regression models. RESULTS: Unmet need for modern contraceptive methods was significantly higher among rural to rural migrant women (OR 1.30, 95%CI 1.00-1.70 p < 0.05) and rural non-migrant women (OR 1.41, 95%CI 1.06-1.85 p < 0.01) compared to urban non-migrant women after controlling for age, marital status, parity, religion, education and wealth. CONCLUSION: Women residing in, and migrating between, rural areas were significantly more likely to have an unmet need for contraception. Our findings highlight the importance of understanding migration and migrant streams to strengthen family planning programs. In Zambia, a focus on rural-rural migrants, rural non-migrants and the poorest could improve the health of the entire population.

Who pays and how much? A cross-sectional study of out-of-pocket payment for modern contraception in Kenya.

OBJECTIVES: Out-of-pocket (OOP) payment for modern contraception is an understudied component of healthcare financing in countries like Kenya, where wealth gradients in met need have prompted efforts to expand access to free contraception. This study aims to examine whether, among public sector providers, the poor are more likely to receive free contraception and to compare how OOP payment for injectables and implants-two popular methods-differs by public/private provider type and user's sociodemographic characteristics. DESIGN, SETTING AND PARTICIPANTS: Secondary analyses of nationally representative, cross-sectional household data from the 2014 Kenya Demographic and Health Survey. Respondents were women of reproductive age (15-49 years). The sample comprised 5717 current modern contraception users, including 2691 injectable and 1073 implant users with non-missing expenditure values. MAIN OUTCOME: Respondent's self-reported source and payment to obtain their current modern contraceptive method. METHODS: We used multivariable logistic regression to examine predictors of free public sector contraception and compared average expenditure for injectable and implant. Quintile ratios examined progressivity of non-zero expenditure by wealth. RESULTS: Half of public sector users reported free contraception; this varied considerably by method and region. Users of implants, condoms, pills and intrauterine devices were all more likely to report receiving their method for free (p<0.001) compared with injectable users. The poorest were as likely to pay for contraception as the wealthiest users at public providers (OR: 1.10, 95% CI: 0.64 to 1.91). Across all providers, among users with non-zero expenditure, injectable and implant users reported a mean OOP payment of Kenyan shillings (KES) 80 (US$0.91), 95% CI: KES 78 to 82 and KES 378 (US$4.31), 95% CI: KES 327 to 429, respectively. In the public sector, expenditure was pro-poor for injectable users yet weakly pro-rich for implant users. CONCLUSIONS: More attention is needed to targeting subsidies to the poorest and ensuring government facilities are equipped to cope with lost user fee revenue.

Comparing time and motion methods to study personnel time in the context of a family planning supply chain intervention in Senegal.

BACKGROUND: A family planning (FP) supply chain intervention was introduced in Senegal in 2012 to reduce contraceptive stock-outs. Labour is the highest cost in low- and middle-income country supply chains. In this paper, we (1) understand time use of personnel working in the FP supply chain at health facilities in Senegal, (2) estimate the validity of self-administered timesheets (STs) relative to continuous observations (COs), and (3) describe the cost of data collection for each method. METHODS: We collected time use data for seven stockroom managers in six facilities using both ST and CO. Activities were categorized as follows: stock management associated with FP, non-FP stock management, other productive activities, non-productive activities, and waiting time. Paired t tests were used to compare the mean differences between the two methods in all categories and in productive time alone. RESULTS: Among all activities, the absolute and relative time spent on productive activities was higher when estimated by ST compared to CO. Conversely, waiting time was underestimated by STs. There was no difference in the relative time spent on non-productive activities. When comparing the distribution of the three productive activity categories, we found no evidence of a difference in relative time percentage estimates between CO and ST (FP stockroom management - 3.0%, 95% CI - 7.4 to 1.4%; non-FP stockroom management 3.4%, 95% CI - 2.8 to 9.6%; and other productive activities - 0.1%, 95% CI - 6.3 to 6.0%). Data collection costs for CO are 140% more than ST. CONCLUSION: STs were not a reliable method for measuring absolute labour time at health facilities in Senegal due to considerable underestimates of time waiting for clients. However, ST had acceptable reliability when examining distribution of productive time. Although CO provides more accurate absolute time estimates, the unit costs for data collection using this method are more than triple those for STs in Senegal.

Two decades of antenatal and delivery care in Uganda: a cross-sectional study using Demographic and Health Surveys.

BACKGROUND: Uganda halved its maternal mortality to 343/100,000 live births between 1990 and 2015, but did not meet the Millennium Development Goal 5. Skilled, timely and good quality antenatal (ANC) and delivery care can prevent the majority of maternal/newborn deaths and stillbirths. We examine coverage, equity, sector of provision and content of ANC and delivery care between 1991 and 2011. METHODS: We conducted a repeated cross-sectional study using four Uganda Demographic and Health Surveys (1995, 2000, 2006 and 2011).Using the most recent live birth and adjusting for survey sampling, we estimated percentage and absolute number of births with ANC (any and 4+ visits), facility delivery, caesarean sections and complete maternal care. We assessed socio-economic differentials in these indicators by wealth, education, urban/rural residence, and geographic zone on the 1995 and 2011 surveys. We estimated the proportions of ANC and delivery care provided by the public and private (for-profit and not-for-profit) sectors, and compared content of ANC and delivery care between sectors. Statistical significance of differences were evaluated using chi-square tests. RESULTS: Coverage with any ANC remained high over the study period (> 90% since 2001) but was of insufficient frequency; < 50% of women who received any ANC reported 4+ visits. Facility-based delivery care increased slowly, reaching 58% in 2011. While significant inequalities in coverage by wealth, education, residence and geographic zone remained, coverage improved for all indicators among the lowest socio-economic groups of women over time. The private sector market share declined over time to 14% of ANC and 25% of delivery care in 2011. Only 10% of women with 4+ ANC visits and 13% of women delivering in facilities received all measured care components. CONCLUSIONS: The Ugandan health system had to cope with more than 30,000 additional births annually between 1991 and 2011. The majority of women in Uganda accessed ANC, but this contact did not result in care of sufficient frequency, content, and continuum of care (facility delivery). Providers in both sectors require quality improvements. Achieving universal health coverage and maternal/newborn SDGs in Uganda requires prioritising poor, less educated and rural women despite competing priorities for financial and human resources.

Why not? Understanding the spatial clustering of private facility-based delivery and financial reasons for homebirths in Nigeria.

BACKGROUND: In Nigeria, the provision of public and private healthcare vary geographically, contributing to variations in one's healthcare surroundings across space. Facility-based delivery (FBD) is also spatially heterogeneous. Levels of FBD and private FBD are significantly lower for women in certain south-eastern and northern regions. The potential influence of childbirth services frequented by the community on individual's barriers to healthcare utilization is under-studied, possibly due to the lack of suitable data. Using individual-level data, we present a novel analytical approach to examine the relationship between women's reasons for homebirth and community-level, health-seeking surroundings. We aim to assess the extent to which cost or finance acts as a barrier for FBD across geographic areas with varying levels of private FBD in Nigeria. METHOD: The most recent live births of 20,467 women were georeferenced to 889 locations in the 2013 Nigeria Demographic and Health Survey. Using these locations as the analytical unit, spatial clusters of high/low private FBD were detected with Kulldorff statistics in the SatScan software package. We then obtained the predicted percentages of women who self-reported financial reasons for homebirth from an adjusted generalized linear model for these clusters. RESULTS: Overall private FBD was 13.6% (95%CI = 11.9,15.5). We found ten clusters of low private FBD (average level: 0.8, 95%CI = 0.8,0.8) and seven clusters of high private FBD (average level: 37.9, 95%CI = 37.6,38.2). Clusters of low private FBD were primarily located in the north, and the Bayelsa and Cross River States. Financial barrier was associated with high private FBD at the cluster level - 10% increase in private FBD was associated with + 1.94% (95%CI = 1.69,2.18) in nonusers citing cost as a reason for homebirth. CONCLUSIONS: In communities where private FBD is common, women who stay home for childbirth might have mild increased difficulties in gaining effective access to public care, or face an overriding preference to use private services, among other potential factors. The analytical approach presented in this study enables further research of the differentials in individuals' reasons for service non-uptake across varying contexts of healthcare surroundings. This will help better devise context-specific strategies to improve health service utilization in resource-scarce settings.

Early breastfeeding practices: Descriptive analysis of recent Demographic and Health Surveys.

The aim of this study was to describe early breastfeeding practices (initiation within 1 hr of birth, no prelacteal feeding, and a combination of both-"optimal" early breastfeeding) according to childbirth location in low- and middle-income countries. Using data from the most recent Demographic and Health Survey (2000-2013) for 57 countries, we extracted information on the most recent birth for women aged 15-49 with a live birth in the preceding 24 months. Childbirth setting was self-reported by location (home or facility) and subtype (home delivery with or without a skilled birth attendant; public or private facility). We produced overall world and four region-level summary statistics by applying national population adjusted survey weights. Overall, 39% of children were breastfed within 1 hr of birth (region range 31-60%), 49% received no prelacteal feeding (41-65%), and 28% benefited from optimal early breastfeeding (21-46%). In South/Southeast Asia and Sub-Saharan Africa, early breastfeeding outcomes were more favourable for facility births compared to home births; trends were less consistent in Latin America and Middle East/Europe. Among home deliveries, there was a higher prevalence of positive breastfeeding practices for births with a skilled birth attendant across all regions other than Latin America. For facility births, breastfeeding practices were more favourable among those taking place in the public sector. This study is the most comprehensive assessment to date of early breastfeeding practices by childbirth location. Our results suggest that skilled delivery care-particularly care delivered in public sector facilities-appears positively correlated with favourable breastfeeding practices.

Pathways to increased coverage: an analysis of time trends in contraceptive need and use among adolescents and young women in Kenya, Rwanda, Tanzania, and Uganda.

BACKGROUND: Despite efforts to make contraceptive services more "youth friendly," unmet need for contraception among young women in sub-Saharan Africa remains high. For health systems to effectively respond to the reproductive health needs of a growing youth population, it is imperative to understand their contraceptive needs and service seeking practices. This paper describes changes over time in contraceptive need, use, and sources of care among young women in four East African countries. METHODS: We used three rounds of DHS data from Kenya, Rwanda, Tanzania, and Uganda to examine time trends from 1999 to 2015 in met need for modern contraception, method mix, and source of care by sector (public or private) and type of provider among young women aged 15-24 years. We assessed disparities in contraceptive coverage improvements over time between younger (15-24 years) and older women (25-49 years) using a difference-in-differences approach. RESULTS: Met need for contraception among women aged 15-24 years increased over time, ranging from a 20% increase in Tanzania to more than a 5-fold increase in Rwanda. Improvements in met need were greater among older women compared to younger women in Rwanda and Uganda, and higher among younger women in Kenya. Injectables have become the most popular contraceptive choice among young women, with more than 50% of modern contraceptive users aged 15-24 years currently using the method in all countries except for Tanzania, where condoms and injectables are used by 38% and 35% of young users, respectively. More than half of young women in Tanzania and Uganda receive contraceptives from the private sector; however, while the private sector played an important role in meeting the growing contraceptive needs among young women in Tanzania, increased use of public sector services drove expanded access in Kenya, Rwanda, and Uganda. CONCLUSIONS: Our study shows that contraceptive use increased among young East African women, yet, unmet need remains high. As youth populations continue to grow, governments must develop more targeted strategies for expanding access to reproductive health services for young women. Engaging the private sector and task-shifting to lower-level providers offer promising approaches; however, additional research is needed to identify the key facilitators and barriers to the success of these strategies in different contexts.

Examining trends in family planning among harder-to-reach women in Senegal 1992-2014.

Recent increases in family planning (FP) use have been reported among women of reproductive age in union (WRAU) in Senegal. However, trends have not been monitored among harder-to-reach groups (including adolescents, unmarried and rural poor women), key to understanding whether FP progress is equitable. We combined data from six Demographic and Health Surveys conducted in Senegal between 1992/93 and 2014. We examined FP trends over time among WRAU and subgroups, and trends in knowledge of FP and intention to use among women with unmet need for FP. Our results show that percent demand satisfied is lower among rural poor women and adolescents than WRAU, although higher among unmarried women. Marked recent increases have been observed in all subgroups, however fewer than 50% of women in need of FP use modern contraception in Senegal. Knowledge of FP has risen steadily among women with unmet need; however, intention to use FP has remained stable at around 40% since 2005 for all groups except unmarried women (75% of whom intend to use). Significant progress in meeting the need for FP has been achieved in Senegal, but more needs to be done particularly to improve acceptability of FP, and to strategically target interventions toward adolescents and rural poor women.

Taking stock: protocol for evaluating a family planning supply chain intervention in Senegal.

BACKGROUND: In Senegal, only 12% of women of reproductive age in union (WRAU) were using contraceptives and another 29% had an unmet need for contraceptives in 2010-11. One potential barrier to accessing contraceptives is the lack of stock availability in health facilities where women seek them. Multiple supply chain interventions have been piloted in low- and middle-income countries with the aim of improving contraceptive availability in health facilities. However, there is limited evidence on the effect of these interventions on contraceptive availability in facilities, and in turn on family planning use in the population. This evaluation protocol pertains to a supply chain intervention using performance-based contracting for contraceptive distribution that was introduced throughout Senegal between 2012 and 2015. METHODS: This multi-disciplinary research project will include quantitative, qualitative and economic evaluations. Trained researchers in the different disciplines will implement the studies separately but alongside each other, sharing findings throughout the project to inform each other's data collection. A non-randomised study with stepped-wedge design will be used to estimate the effect of the intervention on contraceptive stock availability in health facilities, and on the modern contraceptive prevalence rate among women in Senegal, compared to the current pull-based distribution model used for other commodities. Secondary data from annual Service Provision Assessments and Demographic and Health Surveys will be used for this study. Data on stock availability and monthly family planning consultations over a 4-year period will be collected from 200 health facilities in five regions to perform time series analyses. A process evaluation will be conducted to understand the extent to which the intervention was implemented as originally designed, the acceptability of third-party logisticians within the health system and potential unintended consequences. These will be assessed using monthly indicator data from the implementer and multiple ethnographic methods, including in-depth interviews with key informants and stakeholders at all levels of the distribution system, observations of third-party logisticians and clinic diaries. An economic evaluation will estimate the cost of the intervention, as well as its cost-effectiveness compared to the current supply chain model. DISCUSSION: Given the very limited evidence base, there is an important need for a comprehensive standardised approach to evaluating supply chain management, and distribution specifically. This evaluation will help address this evidence gap by providing rigorous evidence on whether private performance-based contracting for distribution of contraceptives can contribute to improving access to family planning in low- and middle-income countries.

Family planning, antenatal and delivery care: cross-sectional survey evidence on levels of coverage and inequalities by public and private sector in 57 low- and middle-income countries.

OBJECTIVE: The objective of this study was to assess the role of the private sector in low- and middle-income countries (LMICs). We used Demographic and Health Surveys for 57 countries (2000-2013) to evaluate the private sector's share in providing three reproductive and maternal/newborn health services (family planning, antenatal and delivery care), in total and by socio-economic position. METHODS: We used data from 865 547 women aged 15-49, representing a total of 3 billion people. We defined 'met and unmet need for services' and 'use of appropriate service types' clearly and developed explicit classifications of source and sector of provision. RESULTS: Across the four regions (sub-Saharan Africa, Middle East/Europe, Asia and Latin America), unmet need ranged from 28% to 61% for family planning, 8% to 22% for ANC and 21% to 51% for delivery care. The private-sector share among users of family planning services was 37-39% across regions (overall mean: 37%; median across countries: 41%). The private-sector market share among users of ANC was 13-61% across regions (overall mean: 44%; median across countries: 15%). The private-sector share among appropriate deliveries was 9-56% across regions (overall mean: 40%; median across countries: 14%). For all three healthcare services, women in the richest wealth quintile used private services more than the poorest. Wealth gaps in met need for services were smallest for family planning and largest for delivery care. CONCLUSIONS: The private sector serves substantial numbers of women in LMICs, particularly the richest. To achieve universal health coverage, including adequate quality care, it is imperative to understand this sector, starting with improved data collection on healthcare provision.

Who, What, Where: an analysis of private sector family planning provision in 57 low- and middle-income countries.

OBJECTIVE: Family planning service delivery has been neglected; rigorous analyses of the patterns of contraceptive provision are needed to inform strategies to address this neglect. METHODS: We used 57 nationally representative Demographic and Health Surveys in low- and middle-income countries (2000-2013) in four geographic regions to estimate need for contraceptive services, and examined the sector of provision, by women's socio-economic position. We also assessed method mix and whether women were informed of side effects. RESULTS: Modern contraceptive use among women in need was lowest in sub-Saharan Africa (39%), with other regions ranging from 64% to 72%. The private sector share of the family planning market was 37-39% of users across the regions and 37% overall (median across countries: 41%). Private sector users accessed medical providers (range across regions: 30-60%, overall mean: 54% and median across countries 23%), specialised drug sellers (range across regions: 31-52%, overall mean: 36% and median across countries: 43%) and retailers (range across regions: 3-14%, overall mean: 6% and median across countries: 6%). Private retailers played a more important role in sub-Saharan Africa (14%) than in other regions (3-5%). NGOs and FBOs served a small percentage. Privileged women (richest wealth quintile, urban residents or secondary-/tertiary-level education) used private sector services more than the less privileged. Contraceptive method types with higher requirements (medical skills) for provision were less likely to be acquired from the private sector, while short-acting methods/injectables were more likely. The percentages of women informed of side effects varied by method and provider subtype, but within subtypes were higher among public than private medical providers for four of five methods assessed. CONCLUSION: Given the importance of private sector providers, we need to understand why women choose their services, what quality services the private sector provides, and how it can be improved. However, when prioritising one of the two sectors (public vs. private), it is critical to consider the potential impact on contraceptive prevalence and equity of met need.

Role of the private sector in childbirth care: cross-sectional survey evidence from 57 low- and middle-income countries using Demographic and Health Surveys.

OBJECTIVE: Maternal mortality rates have decreased globally but remain off track for Millennium Development Goals. Good-quality delivery care is one recognised strategy to address this gap. This study examines the role of the private (non-public) sector in providing delivery care and compares the equity and quality of the sectors. METHODS: The most recent Demographic and Health Survey (2000-2013) for 57 countries was used to analyse delivery care for most recent birth among >330 000 women. Wealth quintiles were used for equity analysis; skilled birth attendant (SBA) and Caesarean section rates served as proxies for quality of care in cross-sectoral comparisons. RESULTS: The proportion of women who used appropriate delivery care (non-facility with a SBA or facility-based births) varied across regions (49-84%), but wealth-related inequalities were seen in both sectors in all regions. One-fifth of all deliveries occurred in the private sector. Overall, 36% of deliveries with appropriate care occurred in the private sector, ranging from 9% to 46% across regions. The presence of a SBA was comparable between sectors (≥93%) in all regions. In every region, Caesarean section rate was higher in the private compared to public sector. The private sector provided between 13% (Latin America) and 66% (Asia) of Caesarean section deliveries. CONCLUSION: This study is the most comprehensive assessment to date of coverage, equity and quality indicators of delivery care by sector. The private sector provided a substantial proportion of delivery care in low- and middle-income countries. Further research is necessary to better understand this heterogeneous group of providers and their potential to equitably increase the coverage of good-quality intrapartum care.

Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial.

BACKGROUND: An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature. METHODS: Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide. RESULTS: Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other. CONCLUSIONS: The main challenges in designing this trial were maintaining a balance between a robust intervention to support effective behaviour change and introducing practices that would be sustainable in a real-life situation in tropical Africa; as well as achieving a detailed evaluation without inadvertently influencing prescribing behaviour. TRIAL REGISTRATION: NCT01194557 registered with ClinicalTrials.gov 2 September 2010.