Sustainability of market-based community distribution of Sprinkles in Western Kenya

To evaluate the sustainability of market-based community distribution of micronutrient powders (Sprinkles®, Hexagon Nutrition, Mumbai, India.) among pre-school children in Kenya, we conducted in August 2010 a follow-up survey, 18 months after study-related marketing and household monitoring ended. We surveyed 849 children aged 6-35 months randomly selected from 60 study villages. Nutritional biomarkers were measured by fingerstick; demographic characteristics, Sprinkles purchases and use were assessed through household questionnaires. We compared Sprinkles use, marketing efforts and biomarker levels with the data from surveys conducted in March 2007, March 2008 and March 2009. We used logistic regression to evaluate associations between marketing activities and Sprinkles use in the 2010 survey. At the 2010 follow-up, 21.9% of children used Sprinkles in the previous 7 days, compared with 64.9% in 2008 (P<0.001). Average intake was 3.2 sachetsweek-1 in 2008, 1.6 sachetsweek-1 in 2009 and 1.1 sachetsweek-1 in 2010 (P<0.001). Factors associated with recent Sprinkles use in 2010 included young age [6-23 months vs. 24-35 months, adjusted odds ratio (aOR)=1.5, P=0.02], lowest 2 quintiles of socio-economic status (aOR=1.7, P=0.004), household attendance at trainings or launches (aOR=2.8, P<0.001) and ever receiving promotional items including free Sprinkles, calendars, cups and t-shirts (aOR=1.7, P=0.04). In 2010, there was increased prevalence of anaemia and malaria (P<0.001), but not iron deficiency (P=0.44), compared with that in 2008. Sprinkles use in 2010 was associated with decreased iron deficiency (P=0.03). Sprinkles coverage reduced after stopping household monitoring and reducing marketing activities. Continued promotion and monitoring of Sprinkles usage may be important components to sustain the programme. © 2012 Blackwell Publishing Ltd. We conducted a follow‐up cross‐sectional survey among 60 villages that had previously participated in the Nyando Integrated Child Health and Education Project (NICHE), which involved the promotion and sale of evidence‐based health products, including Sprinkles, in western Kenya. NICHE was a community‐based, cluster‐randomised trial with two primary objectives: (1) to measure the effectiveness of Sprinkles distribution through an integrated health promotion and income‐generating programme and (2) to measure the impact of Sprinkles sales on anaemia, iron deficiency and vitamin A deficiency among young children. The intervention was implemented by the Safe Water and AIDS Project (SWAP), which utilises an innovative approach to increase access to evidence‐based health products in rural Kenya, mainly by supporting community vendor groups who sell health products to their neighbours. Sprinkles were sold alone or with other SWAP products, including water disinfectant, soap, insecticide‐treated bed nets (ITNs) and condoms. Sachets of Sprinkles were purchased wholesale by SWAP vendors for 1 Kenya shilling (KES) (≈ 1.3¢). Vendors were instructed to resell them at a retail price in their village and surrounding areas for 2 KES (≈ 2.7¢) per sachet. Sprinkles were marketed for daily use (at least 1–2 sachets week−1 to achieve health benefits) to families with children aged 6–59 months living in Nyando Division, a largely rural region within Nyanza Province in western Kenya that has approximately 80 000 people and 15 000 households. Details of the study are described elsewhere (CDC 2007; Suchdev et al. 2010 2012). Figure 1 shows the timeline of Sprinkles distribution in the study area and follow‐up evaluations that were conducted in all 60 study villages as part of NICHE from 2007 to 2010. Sprinkles were first distributed by SWAP in July 2007, 3 months after a baseline survey of 1063 children aged 6–35 months that was conducted in both the intervention and the comparison communities. Extensive qualitative research was conducted prior to and during initial Sprinkles implementation (Jefferds et al. 2010). During the first year of the study, Sprinkles were only marketed and distributed in the 30 intervention villages as part of the cluster‐randomised trial design. In March 2008, we measured the effects of Sprinkles sales on anaemia, iron deficiency and vitamin A deficiency. In addition to enrolling children aged 18–47 months followed from baseline, to account for ageing effects, we also enrolled new births aged 6–18 months from study households. In June 2008, Sprinkles sales were scaled‐up to all 60 villages, and a repeat survey of newly sampled children aged 6–35 months was conducted in March 2009. Between 2007 and 2009, NICHE study staff visited households every 2 weeks to monitor Sprinkles purchases and use. Following the March 2009 survey, SWAP assumed programmatic and monitoring and evaluation activities of Sprinkles that included ongoing promotion and marketing of Sprinkles in the study villages as well as monitoring of Sprinkles sales to vendors. External financial and technical support for the Sprinkles programme was no longer provided by the Centers for Disease Control and Prevention (CDC) or other international partners. Timeline of Sprinkles distribution and programme evaluation in Nyando Division, Kenya. In August 2010, 18 months after programmatic activities by the outside agencies ended, and 42 months after the initial Sprinkles distribution in the intervention study area, a cross‐sectional survey was conducted in the 60 study villages. Because we hypothesised that Sprinkles use had decreased and anaemia prevalence would have increased, sample size estimates were based on an estimated change in anaemia prevalence from 45% (March 2009) to 53% (August 2010). At a confidence level of 95%, power of 80%, design effect of 1.5 and non‐response rate of 20%, the estimated sample size was 1150 children. Using a household census conducted in March 2009, 19 compounds were randomly selected per village. Lists of selected compounds were provided to the field team, and all children aged 6–35 months living in these compounds were approached for enrolment. Trained fieldworkers administered questionnaires to study participants' mothers to collect demographic and socio‐economic data, exposure to Sprinkles marketing activities (at any point during the study period) and information on Sprinkles purchases and use. They also collected anthropometric measurements and capillary blood samples from a fingerstick for use in haemoglobin (Hb) measurements, malaria smear preparations and Microtainer® (Becton Dickinson, Franklin Lakes, NJ, USA) blood collection to assess iron and vitamin A status and the presence of inflammation among enrolled children. Details of the laboratory analysis are described elsewhere (Grant et al. 2012). Hb levels were measured in the field using HemoCue® (HemoCue, Inc. Cypress, CA, USA) photometers; children with Hb < 11.0 g dL−1 were classified as anaemic (McLean et al. 2009). Testing for the presence of malaria parasites and the level of parasitaemia was performed by the CDC laboratory in Kisian, Kenya. Frozen plasma samples were transported to a laboratory in Germany, which measured levels of ferritin, retinol‐binding protein (RBP) and C‐reactive protein (CRP) using a sandwich enzyme‐linked immunosorbent assay technique (Erhardt et al. 2004). The following thresholds were used to define abnormal values for these biochemical indicators: ferritin < 12 μg L−1; RBP < 0.7 μmol L−1 and CRP > 10 mg l−1 (Erhardt et al. 2004). Approaches to account for the effect of infection or inflammation on ferritin and RBP levels include exclusion of individuals with inflammation based on elevated values of one or more acute‐phase proteins (e.g. CRP) (WHO/CDC 2004), or use of correction factors to adjust for the effects of inflammation (Thurnham et al. 2003 2010). In line with the current World Health Organization (WHO)/CDC recommendations, we excluded subjects with elevated CRP levels from analyses of the relationship between Sprinkles intake and levels of ferritin and RBP (n = 146, 63, 102 and 242 from each survey, respectively) (WHO/CDC 2004). For the purposes of this analysis, we used low ferritin as the indicator of choice for iron deficiency (WHO/CDC 2004). In addition to the four cross‐sectional surveys (Fig. 1), we also reviewed SWAP office records to calculate the number of distributed promotional items and the number of Sprinkles sachets that were sold wholesale to vendors. Data cleaning and analyses were performed with sas software (version 9.2; SAS Institute Inc., Cary, NC, USA) and spss (version 19; SPSS Inc., Chicago, IL, USA). We used the WHO Child Growth Standards (WHO Anthro, Geneva, Switzerland) to calculate z‐scores and categorised underweight as weight‐for‐age z‐score < −2, stunting as height/length‐for‐age z‐score < −2 and wasting as weight‐for‐height/length z‐score < −2. We divided participants into socio‐economic quintiles on the basis of household asset scores calculated by assigning values to housing materials and household possessions (Gwatkin et al. 2007). To evaluate the sustainability of the Sprinkles intervention, we compared the main findings from cross‐sectional surveys in 2008, 2009 and 2010 using analysis of variance (ANOVA) for continuous variables and the Mantel–Haenszel chi‐square test for linear trend for categorical variables. Primary outcomes included individual Sprinkles use and nutritional biomarkers. Covariates included both individual (age, gender) and household‐level (attendance at promotional launches or trainings, receipt of promotional items, socio‐economic status, maternal education and whether or not the household was part of the prior NICHE study) measures. We used logistic regression to identify factors associated with Sprinkles use. We also developed a model to determine variables that were associated with anaemia with primary exposures of interest including study year (to measure changes over time) and Sprinkles use. Models were adjusted for the following covariates using backward regression: age, gender, height‐for‐age z‐score, inflammation, iron deficiency, vitamin A deficiency and malaria. Analyses were adjusted for clustering at the village‐level. We considered P‐values <0.05 to be indicative of significant differences between groups. Ethical approval was obtained from the institutional review boards of the Kenya Medical Research Institute and the US CDC. This trial is registered at http://clinicaltrials.gov, identifier {"type":"clinical-trial","attrs":{"text":"NCT01088958","term_id":"NCT01088958"}}NCT01088958.