Strategies to Increase Antenatal Iron and Folic Acid Supplementation and Malaria Prophylaxis in Rural South-central Côte d'Ivoire: Study Protocol of a Cluster Randomised Controlled Trial

Background Despite major progress in antennal care (ANC) access over the past years, coverage of essential antenatal interventions remains limited in many low- and middle-income countries. At the same time, rates of maternal anemia and exposure to malaria in pregnancy remain high. In Côte d'Ivoire, 59% of pregnant women are estimated to be anemic (Hb< 110g/L), and only a minority of women receive antenatal iron supplementation consistently throughout their pregnancy and less than one third of women received intermittent preventive treatment of malaria in pregnancy (IPTp). Both interventions have been shown to be highly effective for reducing the risk of stillbirth, prematurity and low birth weight, and have been highlighted as essential for reducing the burden of malnutrition in the 2013 Lancet series. Low coverage rates of essential ANC interventions have been attributed to lacking demand from beneficiaries (e.g. low ANC attendance), weak early health system contact with women, limited funding, stock outages and ineffective management of supplies.

In general, limited coverage of essential health services as well as limited adherence to national protocol have been attributed to multiple challenges in the health system. These challenges include the lack of knowledge on importance of medication, interrupted supply and stock outs, high cost of care, lack of availability of services, and demand-side barriers such as distance, education, opportunity cost, and cultural and social barriers. To address these challenges successfully, a large number of community-based studies assessed a range of interventions including community-based distribution of drugs, vaccines, or other public health services. In 2018, a systematic review of strategies identified 28 studies evaluating the treatment coverage in community-based public health programs. These studies covered a range of different strategies, including community-based treatment, distributor incentives, distribution along kinship networks, intensified information, education, and communication activities, fixed-point delivery, conversion from school- to community-based delivery, and management by a non-governmental organization. Services delivered included community-based public child health programs such as vitamin A supplementation, child immunizations, and mass drug administration campaigns targeting neglected tropical diseases. The largest positive influence on treatment coverage was found for 4 strategies: community-directed distribution, incentives to increase distributor motivation, distribution along kinship networks and implementation of intensified IEC activities. A 2016 Cochrane review evaluated the effectiveness of community-based health education and household monetary incentives in child immunization coverage in low and middle-income countries (LMICs). Overall, health education at village meetings or at home, as well as household monetary incentives had only moderate-certainty evidence and little or no effect respectively on full immunization coverage. Vouchers have been widely used also to promote maternal and newborn health in low- and middle-income countries: a systematic review consolidated evidence from seven published systematic reviews on the effects of different types of cash transfers and vouchers on the use and quality of maternity care services. Positive findings were found, indicating that reproductive health voucher programs increased utilization of reproductive health services, improved quality of care, and improved population health outcomes. In another Cochrane review focusing directly on antenatal care, 34 randomized controlled trials testing community-based interventions to improve uptake of antenatal care (media campaigns, education or financial incentives for pregnant women), and health systems interventions (home visits for pregnant women or equipment for clinics) were identified. The review highlighted several potentially effective interventions, and suggested a combination of interventions for stronger impact.

Overall, evidence on the most effective ways to increase both IPTp and AIFAS remains mixed overall, with very few studies directly identifying cost-effective ways to increase coverage of both interventions. The objective of the proposed research is to assess both the cost, impact and relative cost-effectiveness of two of the most commonly used strategies in a rural low-income setting compared to the default system. This will help to identify the most effective ways to increase antenatal iron and folic acid supplementation (AIFAS) and IPT-p coverage among pregnant women in rural Cote d'Ivoire and similar settings.

Methods Study design The study will be designed as a cluster-randomized experiment with three arms: a control arm, an information or demand generation arm, and a direct distribution arm. The investigators expected to recruit approximately 240 pregnant women for each arm, for a total sample size of 720 women. This study will be carried out in the HDSS of Taabo in south-central Côte d'Ivoire. The Taabo HDSS has continuously monitored a population of approximately 45,000 since 2009. The pilot study will target 720 pregnant women across the 132 clusters constituting the HDSS monitoring area. The 132 clusters will be split into three groups: a control group (44 clusters), an information group (44 clusters), and a distribution of free supplements group (44 clusters).

Setting The proposed research will be implemented in the Taabo health and demographic surveillance site (HDSS), located some 160 km north-west of Abidjan, the economic capital of Côte d'Ivoire. The study area is mainly rural and covers a surface area of about 980 km2, but already displays clear signs of the epidemiological transition. The Taabo HDSS is situated in the health district of Tiassalé, which has an estimated population of 200,000 people. The HDSS area includes an urban setting (Taabo-Cité), 13 villages, and more than 100 small hamlets. Demographic data (i.e. pregnancy, birth, death, and in- and out-migration) are collected longitudinally at the individual and household level, usually in three data collection rounds per year. Deaths are reported by key informants and verbal autopsies are conducted using standard protocols to determine causes of death.