Effect of integrating maternal and child health services, nutrition and family planning services on postpartum family planning uptake at 6 months post-partum in Burkina Faso, Cote d’Ivoire and Niger: a quasi-experimental study protocol

Background: Although several interventions integrating maternal, neonatal, child health and nutrition with family planning have been implemented and tested, there is still limited evidence on their effectiveness to guide program efforts and policy action on health services integration. This study aims to assess the effectiveness of a service delivery model integrating maternal and child health services, nutrition and family planning services, compared with the general standard of care in Burkina Faso, Cote d’Ivoire, and Niger. Methods: This is a quasi experimental study with one intervention group and one control group of 3 to 4 health facilities in each country. Each facility was matched to a control facility of the same level of care that had similar coverage on selected reproductive health indicators such as family planning and post-partum family planning. The study participants are pregnant women (up to 28 weeks of gestational age) coming for their first antenatal care visit. They will be followed up to 6 months after childbirth, and will be interviewed at each antenatal visit and also during visits for infant vaccines. The analyzes will be carried out by intention to treat, using generalized linear models (binomial log or log Poisson) to assess the effect of the intervention on the ratio of contraceptive use prevalence between the two groups of the study at a significance level of 5%, while taking into account the cluster effect and adjusting for potential confounding factors (socio-demographic characteristics of women unevenly distributed at inclusion). Discussion: This longitudinal study, with the provision of family planning services integrated into the whole maternal care continuum, a sufficiently long observation time and repeated measurements, will make it possible to better understand the timeline and the factors influencing women’s decision-making on the use of post-partum family planning services. The results will help to increase the body of knowledge regarding the impact of maternal and child health services integration on the utilization of post-partum family planning taking into account the specific context of sub-Saharan Africa French speaking countries where such information is very needed.

Burkina Faso, Cote d’Ivoire, and Niger are 3 West african French speaking countries with poor level of maternal and child health indicators. Some information related to relevant reproductive health and health service utilization indicators based on demographic and health survey data from theses countries, Burkina Faso (2010), Cote d’Ivoire (2011–2012) and Niger (2012) are presented in Table ​Table11. Selected indicators on reproductive health and utilization of maternal and child health services Burkina Faso (2010), Cote d’Ivoire (2011–2012) and Niger (2012) aAmong women in union We will conduct a quasi experimental study in the selected countries health facilities. In each country, we will have one intervention group of facilities and one control group of facilities. Participants of the intervention group, meaning women attending the intervention facilities, will receive the full package of integrated PPFP/MNCH/Nutrition services, while participants in the control group will receive standard care. In each country, 3 to 4 health facilities have been identified as the intervention sites including a district hospital, an urban health center, and a rural health center. Each facility was matched to a control facility of the same level of care and that had similar coverage on selected reproductive health indicators such as family planning and post-partum family planning (Table ​(Table2).2). For each country, the selection of the intervention districts and health facilities was purposively made by a working group on Maternal, Neonatal and Child Health (MNCH) from the Ministry of Health. Sites of study • CMA of Po • CSPS niché at the CMA • CSPS of Tiébélé • CMA of Kombissiri • CSPS niche at the CMA • CSPS de Toécé • HG district of Agnibilekro • CSU of Damé • CSR of Assuamé • HG of Adzopé • CSU Assikoi • CSR Ananguié • HD of Aguié • CSI urban of Aguié • CSI rural of Débi • CS of Zabon Moussou • HD Guidanroumji • CSU urban of Guidanroumji • CSI rural of Karazome • CS of Tabouka HD, CMA, and HG: General Hospital or Health District Hospital; CSPS, CSU, CSR, CSI: Primary Health care facilities (CSU = urban, CSR = rural) As part of the Ouagadougou partnership, the conferences held in Ouagadougou, Burkina Faso (2011) and London (2012) and the creation of FP2020 drew attention to FP in Francophone West African countries, which are lagging far behind other regions in terms of use of modern contraceptive methods [15]. Since then, notable progress has been made in these countries, including a 40% increase in the number of new FP users between 2011 and 2015 [15]. However, additional efforts are still needed for these countries to accelerate the use of essential quality FP and MNCH care [15]. The INSPiRE initiative is a project that aims to support the nine countries of the Ouagadougou Partnership to intensify their efforts by investing in the integration of FP and MNCH services. The vision of the INSPiRE Initiative is that all nine countries of the Ouagadougou Partnership achieve their national objectives in terms of increasing the modern contraceptive prevalence rate (mCPR); preventing maternal and child deaths and preventable diseases; improving maternal nutrition and infant and young child feeding practices, and improving the health, nutrition and well-being of newborns and infants. INSPiRE is based on the development and testing of models of excellence in the delivery of integrated MNH, PPFP and Nutrition services. For the pilot phase of this project implementation, three countries have been selected: Burkina Faso, Cote d’Ivoire and Niger. The model of integrated health service delivery includes the community level (community contacts with community health workers), the intermediate level (rural and urban basic health centers), and the central level with the district hospital. The standard model of integrated PPFP/MNCH/Nutrition service delivery has four points of contact where integrated services should be offered in the health facility: antenatal care, childbirth, postnatal care, and infant wellness visits (Fig. 1). In the model, these services are delivered during the same client visit based on client needs and standards of care. For instance, a pregnant woman would be offered PPFP counseling at each contact with the health system, along with counseling on other services such as maternal and infant nutrition. The intervention of integrated health services delivery Inclusion criteria The study participants are pregnant women who meet the following criteria: Exclusion criteria The study participants will be excluded from the analysis if: Participants will be recruited at the ANC unit. All women coming for their first ANC visit will be invited to participate in the study. Women who accept will be screened according to the inclusion criteria. Those meeting the study criteria will be included in the study. In addition, each woman will have a unique identification number which will be entered in the registers to allow follow up throughout the duration of the study. Women with a pregnancy up to 28 weeks of gestational age will be followed up to 6 months after childbirth, and will be interviewed at each antenatal visit and also during visits for infant vaccination, as detailed in the Table ​Table33. Participants follow-up schedule The primary outcome is the uptake of modern contraceptive methods at 6 months postpartum (proportion of women using modern contraceptives at 6 months in the experimental vs. control group). Secondary outcomes are related to health indicators, services delivered and service utilization, as detailed in the Table ​Table4,4, along with their definition and/or measurement process. Maternal infections will be considered for clinical signs of postpartum infection in mothers before discharge from hospital. Early neonatal infections will be considered as reported by health care providers in the patient file or based on obvious clinical signs of neonatal infection (fever, hypothermia, jaundice). Secondary outcomes of interest According to the Population Division of the United Nations Department of Economic and Social Affairs, the modern contraceptive prevalence among married or in union women in 2020 was estimated at 22.4% Cote d’Ivoire, 28.1% for Burkina Faso and 15.1% for Niger [26]. Considering an improvement of 15% in this proportion, attributable to the intervention, with a power of 80%, a significance level of 5%, and finally an intraclass correlation coefficient of 0.015, Cote d’Ivoire will have the largest sample size, about 88 women per cluster. By increasing the size by 15% to take into account any lost to follow-up related to travel, we’ll have a size of 102 women per health facility, meaning a total of 306 women per group in Cote d’Ivoire, and 268, and 172 per group in Burkina Faso and Niger, respectively. It is important to mention that the project health centers in each country were considered as clusters.And since the number of clusters is known in each country, we calculated the number of participants to be included so that the study have a good power. Details for each country are provided in the Table ​Table55. Parameters used for sample size calculation Data will be collected through direct interview with health facility clients and extraction of data from health facility registers. Direct interview with health facility clients: They will be carried out with the study participants at the various follow-up points. Data will be collected from a standardized questionnaire integrated into electronic tablets.Interviews will be carried out in health centers on the day of the woman’s consultation at her convenience. Otherwise, the interviewer will get in touch with the participant to agree on a day and place for the interview. In addition, these interviews will comply to barrier measures against Covid-19 (wearing a mask and a maintaining a distance of at least one meter between the investigator and the respondent). Data extraction: Data will be extracted from health facilities registers (ANC, Childbirth, post-natal care, Immunization). Data will be collected by six females interviewers per country who speak the local languages. They will be trained for 1 week on the study procedures and the content of the questionnaire. Data quality control procedures will be put in place to ensure that accurate data are recorded in the registers and entered into the database. Guidelines for data collection and the establishment of a registration register will be produced. In order to ensure that data will be collected in a standardized way in all participating health facilities, a pilot test of data collection and data management will be carried out before the beginning of baseline data collection. Data quality reports will be produced regularly for each health facility. Site control supervisions in the participating health facilities will be carried out regularly and a verification of the source data will be carried out to ensure that the data collected is accurate, complete, precise and reliable. The supervisions will be carried out by the principal investigator and the country co-investigators. A statistical analysis plan will be developed. Descriptive statistics will be reported by calculating frequencies and percentages for categorical variables and means, standard deviations, and minimum and maximum values for the continuous variables if they are normally distributed. Since the main outcome is contraceptive use, we will use generalized linear models (binomial log or log Poisson) to assess the effect of interventions on the ratio of contraceptive use prevalence between the two groups of the study at a significance level of 5%, while taking into account the cluster effect and adjusting for potential confounding factors (socio-demographic characteristics of women unevenly distributed at inclusion). All bi and multivariate analyzes will be carried out by intention to treat, including all women, whether or not they continued to visit health centers after inclusion. The unit of analysis will therefore be the woman. The analyzes will be carried out with Stata. This protocol has been approved by the Institutional Review Committee of Intrahealth International as well as the respective ethical committees of the selected countries. To ensure the safety and well-being of participants (healthcare providers and pregnant women) and to ensure no harm to them for this study, the team will take the following measures: There will be no risk to women who decide not to participate in the study. Women who will not consent to participate in the study will receive the same care and access to services as those who have consented to participate in the study. If a condition warranting referral (including domestic violence, substance abuse, HIV counseling and testing, or any other relevant condition) is detected during the provision of antenatal care services (as part of this research), the study team will ensure that the woman is correctly referred and that the appropriate standard referral procedures are followed. The published data will be depersonalized, described in a comprehensive manner, if possible and the anonymity of the participants will be preserved at all times. This study will last 18 months, from July 2021 to December 2022 as follows:

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• Dima Health