Effectiveness of a package of postpartum family planning interventions on the uptake of contraceptive methods until twelve months postpartum in Burkina Faso and the Democratic Republic of Congo: The YAM DAABO study protocol

Background: Postpartum family planning (PPFP) information and services can prevent maternal and child morbidity and mortality in low-resource countries, where high unmet need for PPFP remains despite opportunities offered by routine postnatal care visits. This study aims to identify a package of PPFP interventions and determine its effectiveness on the uptake of contraceptive methods during the first year postpartum. We hypothesize that implementing a PPFP intervention package that is designed to strengthen existing antenatal and postnatal care services will result in an increase in contraceptive use. Methods: This is an operational research project using a complex intervention design with three interacting phases. The pre-formative phase aims to map study sites to establish a sampling frame. The formative phase employs a participatory approach using qualitative methodology to identify barriers and catalysts to PPFP uptake to inform the design of a PPFP intervention package. The intervention phase applies a cluster randomized-controlled trial design based at the primary healthcare level, with the experimental group implementing the PPFP package, and the control group implementing usual care. The primary outcome is modern contraceptive method uptake at twelve months postpartum. Qualitative research is embedded in the intervention phase to understand the operational reasons for success or failure of PPFP services. Discussion: Designing, testing, and scaling-up effective, affordable, and sustainable health interventions in low-resource countries is critical to address the high unmet need for PPFP. Due to socio-cultural complexities surrounding contraceptive use, this research assumes that this is more effectively accomplished by engaging key stakeholders, including adolescents, women, men, key community members, service providers, and policy-makers. At the individual level, knowledge, attitudes, and behaviors of women and couples toward PPFP will likely be influenced by a set of low-cost interventions. At the health service delivery level, the implementation of this trial will probably require a shift in behavior and accountability of providers regarding the systematic integration of PPFP into their clinical practice, as well as the optimization of health service organization to ensure the availability of competent staff and contraceptive supplies. Trial registration: Retrospectively registered in the Pan African Clinical Trials Registry (PACTR201609001784334, 27 September 2016).

To ensure that the PPFP intervention package that will emerge from this trial strengthens the existing ANC and PNC services in primary health care settings, and is effective, safe, sustainable, scalable, and culturally-appropriate, this health services research is grounded by two conceptual frameworks. First, the WHO Health Systems Framework with its six system building blocks (leadership/governance, health care financing, health workforce, medical products and technologies, information and research, and service delivery) [51]. Second, the WHO framework for ensuring human rights in the provision of contraceptive information and services [52] to foster an approach towards optimizing contraceptive choices within the context of repeated visits during routine ANC, postpartum care, and PNC, as recommended by the WHO [53]. This framework comprises the following elements: non-discrimination, availability, accessibility, acceptability, quality, informed-decision making, protection of privacy and confidentiality, participation, and accountability. Both frameworks are interrelated and will inform the design of the PPFP intervention package and the research instruments. For the qualitative and quantitative research phases, the research team will pay attention that no women or adolescent girls will be discriminated against (such as for study participation or in the provision of PPFP information and services), based on their age, marital status, HIV status, membership of a minority, or other medical or social criteria. While ensuring that human rights are upheld in the design and implementation of the study is critical and appears feasible, the researchers are aware that addressing the barriers and catalysts related to the six health system building blocks through the perspective of PPFP is vast and extends well beyond the available study timeframe and resources. For example, the research does not have the objective nor the means to test interventions aimed at reducing health service costs or improving the health information system related to PPFP. The research entails a complex intervention design with three interacting study phases: a pre-formative phase, a formative phase, and an intervention phase. Figure 1 summarizes the overall study design. These phases are interconnected and have specific objectives, methodologies, and results. Although the proposed methods in each phase are not complex per se, the overall intervention design is complex as it contains “several interacting components”, deals with a “number and difficulty of behaviors required by those delivering or receiving the intervention”, and engages a “number of groups or organizational levels targeted by the intervention”, among others [54]. The design follows the recommendations from the Medical Research Council (2008/2010) to develop a complex intervention, determine its feasibility, implement, and evaluate [54]. Overall study design The specific objective of the pre-formative phase is to establish a sampling frame of potential study sites by mapping primary health centers according to pre-established criteria. Health centers are eligible if (1) they offer the continuum of ANC, delivery, and PNC; (2) they provide a selection of at least three modern contraceptive methods, including a barrier method such as condom, a short-term method such as pills, a long-term method such as intra-uterine device and referrals for permanent methods to clients; (3) there were no stock-outs of contraceptives during the preceding six months; (4) they have on average at least thirty deliveries per month; (5) they are situated within four hours drive from the research center; and (6) they are willing to participate. Based on this sampling frame, in each country, three health centers will be chosen conveniently for the formative phase while eight others will be allocated randomly to the experimental and control groups of the intervention phase. The specific objective of the formative phase is to identify through participatory action research a context-specific package of PPFP interventions to be implemented during the intervention phase. Initially, with a view to informing the design of the PPFP intervention package, we will seek the participation of a variety of stakeholders to identify barriers and catalysts related to PPFP uptake. Based on field observations from our research teams, service providers did not integrate systematically PPFP into ANC, delivery care or PNC, and there were no dedicated PPFP job aids or counseling tools, although PPFP information and services should be part of the maternal health continuum of care according to national recommendations. To address these knowledge gaps in our study countries (and in other Sub-Saharan countries in general) and to answer providers’ request for a counseling tool to help them better and more systematically support women, we identified the following potential components that would ensure that PPFP is delivered as part of the intervention package: (i) a counseling tool for clients and providers that is specific to PPFP and for use during ANC and PNC services, and (ii) refresher trainings to enhance service providers’ PPFP knowledge and skills. This preliminary set of interventions will be enriched and undergo changes as results of the participatory action research engaging stakeholders are made available. To be integrated into the final package, interventions will need to take into account existing human resources and clinical capacity at the primary health care level, as wells as costs, acceptability, feasibility, and other field considerations. The specific objective of the intervention phase is to determine, through a cluster randomized controlled (RCT) trial design, the effect of the PPFP intervention package on the uptake of contraceptive methods during the extended postpartum period, in comparison with the standard of care. The intervention phase also integrates qualitative research that is aimed at identifying operational reasons for success or failure in the implementation of PPFP services. The phased approach adopted in this study, with the different specific objectives, levels of activities, and intermediate and final results, is underpinned by the theory of change [55]. This theory is helpful in the design of complex interventions such as the one proposed in this trial: it takes as a starting point the ultimate objective of meeting the contraceptive needs of women during the extended postpartum period; it then engages various stakeholders in identifying the desired intermediate results that aim to strengthen ANC and PNC services, before formulating the interventions that are needed to achieve these results. This backward planning allows from the outset a dynamic and participatory approach through which the final PPFP intervention package will be designed. The theory of change will be applied to design quantitative process indicators and qualitative tools aimed at assessing the level of implementation of the intervention package and how each intervention will be implemented. These process indicators and information will be key to help explain why the package is effective or not and highlight operational barriers and enablers useful for future scale-up and implementation research. We will present the details of the qualitative research and the cluster RCT in the following sections. For the qualitative components of the study (in the formative phase and embedded in the intervention phase), we adopt a participatory approach using focus group discussions (FGD) and in-depth interviews (IDI) with members of the community (women, adolescent girls, partners, people with influence), health staff (service providers, managers), and national policymakers. The formative phase will take place in each country in three conveniently sampled health centers and their respective coverage areas. These sites are drawn from the sampling frame established in the pre-formative phase. For the identification of PPFP barriers and catalysts, we plan separate FGDs of six to ten participants for the following categories of individuals: (a) women who are currently pregnant or who delivered at the health center during the previous 12 months – the age will determine their allocation to subgroups: adolescent girls (≤ 19 years), women 20–39 years, women ≥40 years; (b) men (25–40 years) who are partners or husbands of women who are pregnant or who delivered at the health center during the previous 12 months; and (c) service providers. We will conduct IDIs with clinic managers, policymakers, and individuals whom local informants will identify in each recruitment zone as influential, such as religious leaders, village chiefs, community personalities, or others. Adult participants will give their informed consent. Non-adult participants will give their informed assent and their respective parents or guardians their informed consent. The interview guides will cover the following themes related to PPFP: knowledge, attitudes and practices; socio-cultural and health systems barriers and catalysts; and quality of care, including human rights considerations. We will pilot a draft of the PPFP counseling tool and finalize it during the formative phase using participatory action research principles. We will engage service providers and clients to design and implement the tool and participate in research to assess its ease of understanding, relevance, contents related to human rights principles, and potential impact. Service providers will be trained on the use of the counseling tool through theoretical sessions and role plays, before implementing it with clients in health centers. These clients will be pregnant women attending ANC services or women who delivered in the previous 12 months. We plan separate FGDs with service providers who offered the counseling tool and with women who received counseling with the tool. If partners attended a counseling session with the tool, they will be invited to a separate FGD to provide feedback. Qualitative research embedded in the intervention phase will take place at the eight health centers randomized to the experimental or control groups. In line with the theory of change approach, it will consist of an implementation evaluation to analyze barriers and catalysts related to the delivery of PPFP services, assess intervention fidelity (in the experimental group), and explore approaches for scaling up. Separate FGDs are planned for service providers, participants (≤ 19 years, 20–39 years, ≥ 40 years), and their partners. IDIs are planned for clinic managers. The interview guides will cover the following themes related to PPFP service provision: operational barriers and catalysts; quality of care; human rights; and scaling-up considerations. The semi-structured interview guides are in French. In each country, we will recruit a team of social scientists with relevant experience in qualitative methods and in working in the respective local languages (Mooré in Burkina Faso and Lingala in the DRC). We will train them on how to conduct the interviews, paying attention to finding the most appropriate and clear language to express technical terms in the local languages. The interviews will take place in a location guaranteeing privacy (for example, an empty room in the health facility). The interviews will be audiotaped after obtaining the agreement from participants. Research assistants will transcribe and translate the audio records into French using Microsoft Word. Accuracy checks will be done by comparing transcripts with audio files. We will perform a thematic analysis using QSR NVivo 11 software, a qualitative research management tool. We will establish a basic codebook, which describes all the nodes, and use it to code data. We will enrich the codebook with new emerging nodes during the coding process. Data will be coded by research assistants. To ensure quality of data coding, we will first ask research assistants to code a common transcription sample before performing inter-rater reliability testing by computing the Cohen’s Kappa coefficient. We will consider a Kappa coefficient of 0.8 and above to be an acceptable concordance threshold. Results from the formative phase will be presented and discussed during a research workshop with the key members of each country research team, including selected service providers from the formative sites as well as the WHO coordinating team. Country participants will be iteratively invited to express their views on possible interventions when examining the potential effectiveness of possible interventions, as well as acceptability to women and providers, feasibility, “integrability” into the RMNCH continuum, sustainability, and scalability. Through iterative individual voting and discussion processes, we aim to reach a consensus on the final PPFP intervention package. This is a two-group, non-blinded cluster RCT conducted in the primary health centers in Burkina Faso and the DRC (see Fig. 2 for the cluster RCT flow diagram, and Fig. 3 for the schedule of enrolment, interventions, and assessments (SPIRIT template)). Randomization to control and intervention arms is at the level of the health center. Participants allocated to the experimental group will receive the PPFP intervention package and those allocated to the control group will receive usual care. Service providers who have midwifery and contraceptive skills and who offer ANC, delivery, and PNC services will implement the clinical components of the PPFP package. The cluster RCT design is justified by the fact that the different components of the PPFP intervention package, which will eventually be identified, may not be delivered directly to individual participants but only applied at the level of the health center (e.g. refresher training for service providers, optimization of health service organization). Flow diagram of the cluster randomized control trial in each study country Schedule of enrolment, interventions, and assessments for the cluster randomized controlled trial phase in each study country (SPIRIT template) Case-report forms (CRFs) will be developed for quantitative indicators. The primary outcome is the uptake of modern contraceptive methods at twelve months postpartum (proportion of women using modern contraceptives at twelve months in the experimental vs. control group). Secondary outcomes include: use of a modern contraceptive method upon clinic discharge (24–48 h), at six days, six weeks, six months, and nine months postpartum. Intermediate outcomes include the decision taken at different follow-up points to use a contraceptive method. The proposed postpartum follow-up schedule is in line with current national practices in both study countries, although it is slightly different from those recommended by WHO [53]. In 2013, WHO issued the following recommendations for the timing of postnatal visits: on day 1 (24 h), on day 3 (48–72 h), between days 7 and 14, and at week 6. It is important to note that the cluster RCT is designed to evaluate the effectiveness of a package of PPFP interventions and cannot indicate which specific intervention in the package will have the most impact on postpartum contraceptive uptake. Therefore, we plan a process evaluation with the objectives to: (1) detect implementation issues that could be explanatory in case the intervention is not effective; and (2) facilitate the replication and scale-up of the intervention if it is proven effective. We have therefore developed process indicators in the CRFs to help assess the level of implementation of selected interventions of the package. Event logs and monitoring visit checklists implemented at health centers will offer other sources of process-oriented information. The qualitative research embedded in the intervention phase will further contribute to understanding the barriers and enablers related to the delivery of PPFP and to the implementation of the trial. The process indicators and the embedded qualitative research will give clues as to the components of the package that participants and providers will perceive as having a greater impact. The sample size is estimated based on the following assumptions: among women at six months postpartum, DHS data report 7.2% of use of any method (modern or traditional) in Burkina Faso [56] and 5.1% of use of modern methods in the DRC [10]. These figures allow us to assume that around 5.0% of participants in the control group in both countries will adopt a modern contraceptive at six months postpartum. In Burkina Faso and the DRC, women in the general population have a similar contraceptive prevalence rate for modern methods of 15.0%, which allows us to assume that around 15.0% of participants in the experimental group will use a modern method at six months postpartum. Given the high unmet need for PPFP, we assume that an increased proportion of at least 20.0% of participants in the experimental group will adopt a modern method at twelve months postpartum. This corresponds to a difference of 15.0% between the experimental group (20.0%) and the control group (5.0%). Therefore, assuming an intra-cluster (health center) correlation coefficient of 0.02, we used PASS 11 Software (Power Analysis and Sample Size) for sample size calculation: the experimental group and the control group will each have four study sites with at least 60 participants per site in each study country [57]. This allows for a statistical power of 93% to detect a difference of 15% to a level of significance of 5% at the individual level (and not at the facility level). Assuming a 10% participant loss to follow up, each site will recruit at least 70 pregnant women. This equates to a cohort of 280 pregnant women in each group (4 sites × 70 participants), and in total 560 participants per country (280 participants × 2 study groups). Therefore, across both countries, the study will have a total sample size of 1120 participants (560 in the experimental and 560 in the control group). The study will be conducted in eight primary health centers in each country. The eligibility criteria of health centers were described above under the objective of the pre-formative phase. All pregnant women will be eligible to participate in the study if (1) they are in their third pregnancy trimester; (2) the status of the pregnancy and of the woman allows for a birth at the health center; (3) the woman has the intention to attend ANC, delivery, and PNC at the health center; (4) the woman does not participate in another study; and (5) an informed consent is obtained. The health centers of the experimental group will implement the PPFP intervention package. The control group will implement usual care. Depending on the nature of the final package, some interventions may be implemented before participant recruitment (such as PPFP refresher training for service providers), while others will be implemented afterwards (such as using the PPFP counseling tool with participants). In each country, the eight sites are matched by pairs according to (1) the average number of deliveries per month; (2) the ratio of health workers per population; and (3) the settings (rural, urban). Within each of the four pairs, we will randomly select the site assigned to the experimental intervention. This randomization is performed four times (once for each pair) in each study country. No restriction in the randomization process is required and masking cannot be done. All consecutive and eligible participants will be included in the clusters. Data on key outcome measures as well as quantitative process indicators will be collected on paper-based CRFs. The WHO team in Geneva will develop the CRFs with inputs from the country research teams. We will test advanced drafts with an appropriate sample of service providers and mock clients from the formative phase sites before finalizing the forms. Each health center of the cluster RCT will have a research assistant who will be trained to adhere to the study manual and standard operating procedures for data management which are common to both study countries and have been developed by WHO. The information reported on the CRFs will be checked for accuracy and completeness several times at different levels by field coordinators and data managers. As for other multicenter trials conducted and sponsored by the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) at WHO in Geneva, we will perform data entry and data quality monitoring using a web-based data management system. The Biostatistics and Data Management team at HRP will develop it through OpenClinica (version 3.11), an electronic data capture software for clinical research, which includes programmed edit checks for data accuracy, completeness, and consistency, reduces delays in data queries and problem resolution, and allows the dataset to be quickly available. The OpenClinica system is a highly secure, open-source, and reliable web-based software solution, which is fully compliant with Good Clinical Practice (GCP) and regulatory guidelines and HRP/WHO Standard Operating Procedures for clinical trial managements. Data entry will be performed locally in Ouagadougou and Kinshasa by the collaborating research centers and checked by the WHO team in Geneva. We will train the country teams in data entry and data management using the OpenClinica system. Country research teams will be responsible for verifying the data, uploading them onto shared files and entering the data into the OpenClinica system. To reduce errors, double data entry will be performed. The system will automatically generate queries on data (missing values, outliers, inconsistencies, and other errors). The WHO team will monitor data quality. Questions about data inconsistencies or missing values will be sent to sites using standardized forms and will be resolved on an ongoing basis. Data transmission will be encrypted to ensure data integrity and confidentiality of participants. Access to the data will be password protected: only authorized users will be allowed access to the data. We will prepare a comprehensive statistical analysis plan before finishing recruitment for the study. The participant will form the unit of analysis and intra-cluster correlation coefficient will be accounted for. All analysis will be by intention to treat. We will perform descriptive statistics by computing means, standard deviations, and minimum and maximum values for continuous variables, and frequencies and percentages for categorical variables. As part of quality control and descriptive analysis of the data, we will examine the distribution of variables to detect outliers. Descriptive statistics will be tabulated for individual clusters and aggregated across clusters. We will use IBM SPSS Statistics 21, R, STATA 13, or SAS statistical packages for the analysis. We will present the results according to the 2010 CONSORT Statement checklist and its extension for cluster studies [58]. Threats to the PPFP intervention package fidelity will be minimized by providing an initial training to service providers of the experimental sites and ongoing monitoring and supportive supervision visits to assess adherence to the intervention package. The WHO coordination team will hold weekly teleconferences with each country team and conduct periodic site visits to assess implementation progress. An action plan will be implemented if there are any concerns regarding adherence to the intervention package. In the design of this trial we have taken into account the recommendations provided by The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials [59]. This protocol was peer-reviewed by the Research Project Review Panel (RP2) of the HRP. RP2 and the WHO Research Ethics Review Committee, Geneva, Switzerland, approved the study protocol as well as the respective ethical committees in Burkina Faso (see Declarations for details). Upon completion of the formative phase, we will submit to the same global and local ethical committees the amendments to the protocols, which will include the finalized PPFP intervention package and the related research instruments for the experimental phase.

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