Description of the intervention
The model of integrated health service delivery includes the community level (community contacts with the 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 (Figure 1). In the model, these services are delivered during the same client visit based on client needs and standards of care.
The study will be implemented in three French speaking countries of sub-Saharan West Africa: Burkina Faso, Cote d’Ivoire, and Niger. Some information related to relevant reproductive health and health service utilization indicators based on demographic and health survey data from Burkina Faso (2010), Cote d’Ivoire (2011-2012) and Niger (2012) are presented in Table 1.
Selected indicators on reproductive health and utilization of maternal and child health services Burkina Faso (2010), Cote d’Ivoire (2011-2012) and Niger (2012)
|Cote d’ Ivoire
|Maternal mortality rate
|330 per 100, 000 live births in 2015
|614 per100, 000 live births in 2015
|520 pour 100, 000 live births in 2015
|Neonatal Mortality Rate
|33 per 1,000
|28 per 1,000
|Child Mortality Rate
|42 per 1,000
|27 per 1,000
|48 per 1,000
|Unmet need of FP
|Prevalence of acute malnutrition
|Prevalence of chronic malnutrition
|Prevalence of underweight
|Proportion of infants under 6 months of age who have benefited from Exclusive Breastfeeding
|Proportion of anemia in pregnant women
|*Among women in union
Type of study
This is a quasi experimental study; 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.
Sites of study
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.
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)
The study participants are pregnant women who meet the following criteria :
- Attending maternal health services for ANC;
- Having a 6 months pregnancy at maximum;
- Being a resident of the communities served by the health facility;
- Not planning to travel for more than one month during pregnancy or for six months after childbirth;
- Having the intention from the outset to follow preventive care and childbirth in the health facility.
Participants recruitment process
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.
Participant follow-up procedures
Women (with a 6 months pregnancy at maximum) 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 3 below.
Participants follow-up schedule
Case-report forms (CRFs) will be developed for collecting data on the outcomes of interest. The primary outcome is the uptake of modern contraceptive methods at six months postpartum (proportion of women using modern contraceptives at six months in the experimental vs. control group). Secondary outcomes are related to health indicators and services utilization, as detailed in the table 4 below. 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 to be measured
|Secondary Outcomes of interest
|Number of individual FP counseling sessions during ANC
|Number of ANC visits (retention)
|Nutritional advice received during ANC
|Number of Post-partum visits
|Exclusive breastfeeding 0-6 months
|Nutritional advice received during post- natala care
|Infant growth monitoring (weighing)
|Moderate acute malnutrition
|Severe acute malnutrition
|Vaccine coverage for children 0-6 months
|Vitamin A supplementation and deworming
Sample size calculation
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 . 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. Details for each country are provided in the table 5 below.
Parameters used for sample size calculation
|modern Contraceptive Prevalence rate
|Size of the expected effect in intervention groups
|modern Contraceptive Prevalence rate (expected)
|Intercluster Correlation Coefficient
|Size per cluster
|Size increased per cluster (15% increase)
|Number of clusters per group
|Final size of groups
|Final Size by country
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 center registers (ANC, Childbirth, post-natal care, Immunization).
Recruitment and training of investigators
Data will be collected by 06 females interviewers per country, with a paramedical profile (nurse, midwife), speaking the local languages.
They will be trained for one week on the study procedures and the content of the questionnaire.
Data quality procedures
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. The distribution of variables will be examined for outliers as part of quality control and descriptive analysis of the data. Descriptive statistics will be compiled for each group and aggregated between groups.
The analysis will compare the unadjusted and adjusted primary results between the two study groups, i.e. the experimental group and the comparison group. 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 the Stata software.
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:
• All women meeting the inclusion criteria will be provided with detailed information on the objectives and procedures of the study and free and informed consent will be required prior to inclusion.
o Pregnant women under 18 who are in union will be considered as emancipated minors and consent will be obtained directly as for an adult.
o For pregnant women under the age of 18 who are not in a union, the consent of an adult parent / legal guardian will be required as well as the consent of the young girl.
• All research investigators and study staff will be trained to clearly communicate and perform the consent process.
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, etc., 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 data collected on the tablets will be sent directly to the local IRSS-based server once a week. The server will be protected by a password known only from the Data manager. All research assistants and study staff will be trained to ensure data security.
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:
- 4 months for participants recruitment;
- 11 months of follow-up from the last woman included (she will be recruited during the first trimester of pregnancy at earliest, therefore 5-6 months of follow-up while she is still pregnant and 6 months of follow-up after delivery) ;
- 3 months for the report writing.