Study setting.
The study was implemented in the health district of Tenkodogo which follows the territorial jurisdiction of the province of Boulgou. It covers three (03) communes including one (01) urban commune (Tenkodogo with 06 sectors and 92 villages) and two rural communes (Bagré: 8 villages and Bissiga: 23 villages). There are fifty-five (55) farming hamlets. Tenkodogo is the capital of Boulgou Province and the Centre-East Region. It has an area of 1990 Km2. It is bordered by the health districts of Koupela to the north, Fada to the northeast, Ouargaye to the east, Bittou to the south, Garango to the west; and Zabré and Manga districts in the southwest. The population of the health district in 2020 is estimated at 261,732 inhabitants, according to a projection of the general census of population and housing (RGPH) of the year 2006. In 2018, children under the age of 15 accounted for almost half of the population (47.84%) and women of reproductive age (23.75%). The population density is estimated in 2019 at 124 inhabitants per km2. The fertility rates, crude birth rate and death rate are 203‰, 47.5‰, and 15.3‰ respectively. (Statistical Yearbook 2018) The average household size is 6 people according to the same census. It is a relatively young population with significant migratory movements internationally and in the sub-region.
Study design and sampling technique
We conducted a prospective cohort study.
Study period: The study period was from June 10th to September 05th 2020.
The sample size was calculated from the following formula using the OPEN EPI software. Sample size (n) = [DEFF*Np(1-p)]/ [(d2/Z21-α/2*(N-1) + p*(1-p)] with Z = 1.96 for p = 0.05 or 95% CI, P = the relative status of SPC compliance is not known in Burkina Faso, so we will default to 50%. We retained the accuracy level d at 0.05. The cluster effect was 2 because clusters were formed in both rural and urban areas and children included through a two-level sampling (village and household). n = 762. In anticipation of possible lost follow-up or non-respondents, a 10% increase in size [762/(1-0.1)] was achieved; giving us a total of 847 children aged 3–59 months to investigate.
For sampling, the health district of Tenkodogo was randomly selected from the list of 70 districts in Burkina Faso. The districts were arranged alphabetically and then assigned a serial number from 1 to 70 was assigned to each. Excel software was used to generate a random number between 1 and 70. The number generated corresponded to the chosen district. A cluster sampling was conducted. Areas and villages were considered clusters and listed alphabetically with the size of their target population. After dividing the total population of children aged 3 to 59 months in Tenkodogo Health District (44,599) by 30 (cluster), we obtained a sampling pitch of 1487. Using Excel we randomly generated between 1 and 1487 (= ALEA. COME IN. TERMINALS (1; 1487)] and the number obtained corresponded to the rank of the first cluster. Number 35 has been drawn. We applied this rank to the first cluster and then used the sampling step for the selection of complementary clusters (see table in appendix).
Within each cluster, concessions were chosen randomly using the pen method. Indeed, a pen was thrown at the village level and the tip of the pen indicated the direction to follow to enter the first concession. The other concessions were visited from the left after the first concession until the desired number of children in the cluster were obtained.
Within a concession all the children of the chosen concession meeting the inclusion criteria were selected. The mother/caregiver with multiple children responded for each child. The children targeted by our investigation and absent during the passage of the investigators were not retained;
Study population and inclusion criteria
The study population consisted of children aged 03 to 59 months in the Tenkodogo Health District and their parents/guardians of children (father, mother, concession manager, babysitter). The inclusion criteria for children were: age between 3–59 months, having received SP + AQ during the CPS in 2020 and whose parent or legal guardian has given informed consent to participate in the study and have resided in the study area for one month and desire to do so for at least one month. Inclusion criteria for parents or guardians of children included: being the child's guardian (father, mother, guardian) and having signed an informed consent.
Data collection: variables, tools and techniques
Sociodemographic characteristics of children 03 to 59 months of age and their mothers/caregivers, SMC adherence in children 3 to 59 months of age, malaria incidence in children 03 to 59 months of age in the 28 days after taking SP + QA at the first pass were collected. A child was found to be observant when this one took Sulfadoxine + Pyrimethamine on Day 1, amodiaquine on Day 2 and Day 3 at the same time and he took an alternative dose in case of rejection/vomiting.
Data collection techniques consisted of interviews, literature review and direct observation. Several data collection tools have been developed, namely the questionnaire, the observation grid and the content analysis grid. Simple malaria was defined by the presence of fever (uncorrected axillary temperature greater than or equal to 37.5°C) or a history of hot body in the last 72 hours And the detection of plasmodium on microscopic examination by thick drop/blood smear or the positivity of the rapid diagnostic test (RDT) And the absence of signs of severity or general signs of danger.
The questionnaire was administered face-to-face and consisted of the interviewer recording the respondent's answers on a paper form. Collection was conducted by intermediate field epidemiology training program residents of cohort one of Burkina Faso who were divided into pairs. The initial collection began the day after the SMC ended. A second collection took place two weeks after the initial collection. After the initial collection, the follow-up of the children in the cohort was provided by the community health workers of each village. The follow-up was done on day7, day14, day21, day28. Thus, for children declared sick, residents were immediately informed by telephone by the community health workers. The residents also confirmed the diagnosis of paludism through the necessary media (health record, primary health care facility consultation register, verbal autopsy) and confirmation of the first manager of the health center. The control and supervision of the collection of community health workers was done by the first managers of the health center and the FETP residents. Firsts manager of the health centers supervised and monitored the actions of community health workers once a week. They confirmed the diagnosis of paludism of sick children. Very sick children were cared for at the health center by the first managers and the other members of the health center.
Data analysis
A data entry mask was developed with Epi-info software version 7.2.3.1 by FETP residents. The data was entered into this software and a quality control followed by a cleaning of the database was carried out. It consisted of finding and deleting duplicate records and missing data and correcting outliers.
Analysis of quantitative data was performed using Epi info software version 7.2.3.1. Descriptive statistics of the sample variables in table and/or figure form were carried out, and then the proportions and crude relative risks of malaria were presented according to the different factors studied.
The comparison between qualitative variables was made using Pearson's Chi2 test or Fisher's exact test if more than 20% of the expected values are ≤ 5. The materiality level was set at 0.05. Results were presented with a 95% confidence interval. Also, we use logistic regression model to analyze confusing independent variables for the outcome. The dependent variable was malaria after SMC. This variable was a dichotomic qualitative variable coded 1 if the child had malaria after SMC and 0 if not.
Ethical considerations
The study protocol has been approved by the Burkina Faso national Research Ethics Committee. At the same time, before the field phase, an authorization to collect data was issued by the Secretary General of the Ministry of Health and sent to the Regional Director of Health of the Central East who forwarded it to the Chief Medical Officer of the Tenkodogo Health District. Participation in the study was conditional on the respondent obtaining free and informed consent using an informed consent form.
The confidentiality of the information collected and their anonymity by all stakeholders in this study was respected.