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y los problemas congénitos, y su relación con el aborto en Brasil

5.1.1. Overview of study design

This was an intervention study that used mixed methods. It was designed and conducted in three successive phases in order to achieve the stated aim and objectives (Subchapter 4.2):

Phase 1 - Intervention development:

In this phase, formative qualitative methods were used to achieve Objective 1 (development of the intervention). These methods consisted of focus group discussions with men and

participatory consultations with stakeholders.

Phase 2 - Intervention trial:

In this phase, a randomised controlled trial (RCT) was conducted to achieve Objective 2 (testing the effect of the intervention on health and behavioural outcomes). Adherence to the

intervention was also measured, thus contributing to achieving Objective 3 (assessing factors contributing to intervention success).

Phase 3 - Qualitative process evaluation:

In this phase, semi-structured interviews were conducted with women, men and staff in order to achieve Objective 3 (assessing factors contributing to intervention success).

The methods used in each part phase of the study will be described in detail in the rest of this Chapter. Study Objective 4 (assessing policy implications and dissemination) will be addressed in the General Discussion (Chapter 11).

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5.1.2. Context and study sites

The study was set in Bobo-Dioulasso, the second largest city in Burkina Faso, with a population of 813 610 (INSD, 2015). The city, which is capital of the Hauts Bassins region and of the Houet province, is situated on a strategic transport route connecting the Ivory Coast and the South West of the country to the capital Ouagadougou by road and rail (see map, Figure 3). It is an important commercial node and hosts much of the country’s industrial infrastructure.

The city comprises three health districts (Dafra, Do and Konsa). The study was conducted in the District of Dafra. This District was chosen because of AfricSanté’s connection with a retired senior midwife (Mrs Diane Ouedraogo) who had worked there and introduced us to the District medical director. The District extends beyond the city boundaries to include a portion of countryside. It comprises one District Hospital (CMA), 7 urban and 9 rural PHCs. We planned to conduct the study in primary health care settings in urban Bobo-Dioulasso. A multisite design was necessary in order to recruit a sufficiently large sample for the RCT in the available time. The five largest PHCs in the urban part of the District were therefore chosen: Bolomakote, Guimbi, Sarfalao, Secteur 24 and Ouezzinville (see map, Figure 4). The two smaller urban PHCs were excluded (Tounouma and Secteur 25), because they served fewer pregnant women. The selected PHCs are geographically close and therefore it was reasonable to assume that the populations served would be similar. Being part of the same health district, there is also overlap in service support systems and management culture, and staff know each other from having participated in district-level training courses and other events. Although this reduces the likelihood of observing strong site effects, one theoretical downside of this homogeneity could be a decrease in the generalisability of our results.

All five included PHCs offer antenatal, labour and birth, postnatal and family planning services, and serve the majority of the local population (Ministère de la Santé, 2015b). In 2014, an average of 66 births per month took place in each of the study facilities (Ministère de la Santé, 2015b). Women with obstetric complications are referred to the District Hospital of Dafra (CMA) or the University Hospital of Bobo-Dioulasso (CHU). There are also a number of private maternity clinics, and some family planning NGOs are active in the area (ABBEF, MSI). These serve a smaller clientele, compared to the PHCs.

83 Figure 3: Map of Burkina Faso with major cities

Figure 4: Bobo-Dioulasso health Districts and study PHCs

SECTEUR 24 PHC

DAFRA DISTRICT HOSPITAL

OUEZZINVILLE PHC

BOLOMAKOTE PHC GUIMBI PHC

SARFALAO PHC UNIVERSITY HOSPITAL

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5.1.3. Staffing and roles

A number of people contributed to carrying out this study. Permanent employees of AfricSanté research centre in Bobo-Dioulasso contributed varying proportions of their time to this study, and other people were employed by AfricSanté specifically to work on this study, paid for by the project funds.

85 Table 10: Staffing and roles

PERSON INSTITUTION ROLE

Ms Marina DANIELE LSHTM PhD Candidate:

Study ideation and protocol development.

Fieldwork coordination, including: plan of activities, development of materials and data collection instruments, training of staff, data management, implementation supervision, quality monitoring.

Data analysis and reporting of results. Prof Veronique FILIPPI LSHTM PhD Supervision

Dr R. GANABA Prof Simon COUSENS Dr Clementine ROSSIER Dr Sophie SARASSAT AfricSanté LSHTM Univ. of Geneva LSHTM

PhD Advisors – academic support

Ms Djeneba OUEDRAOGO

AfricSanté Field supervisor: assisted in training quantitative research assistants (RAs), field-testing, coordination and

supervision of quantitative data collection (Phase 2). Qualitative interviewer: conducted semi-structured interviews with women (Phase 3)

Ms Chantal MILLOGO Ms Fatoumata DRABO Ms Adjaratou SOULAMA Ms Antoinette SANOU Ms Fatoumata TRAORE

AfricSanté Research assistants (RAs): completed recruitment of RCT participants and conducted quantitative interviews at baseline and follow-up (Phase 2).

Mr Seydou DRABO Independent consultant/ University of Oslo

Focus group discussion (FGD) facilitator: conducted FGDs with men (Phase 1)

Mr Blahima KONATE Mr Issiaka BAMBA Mr Achille SOULAMA

Centre Muraz Qualitative interviewers: conducted semi-structured interviews with men and providers (Phase 3). 7 Health workers 5 PHCs – District

of Dafra

Staff contact persons: liaison with research team, coordination of study activities in their PHC, further training and supervision of colleagues. (Phase 2) Approximately 100 health

workers (20 per PHC)

5 PHCs – District of Dafra

Participated in the RCT recruitment process. Implemented the intervention in the PHCs: invited participants, facilitated men’s groups and delivered couple counselling sessions.

Collected process data. (Phase 2)

Ms Diane OUEDRAOGO AfricSanté Clinical supervisor: assisted in the quality monitoring of the educational sessions provided as part of the

intervention (Phase 2)

Mr Henri SOME AfricSanté Data manager: developed data entry forms, supervised data entry staff, monitored quality (Phase 2)

Ms Sylvia MARINOVA Mr Edgar DIBOULO Ms Nana ABGA Ms Denise-Emma BATIONO Mr Hamadou SIRIBIE LSHTM AfricSanté AfricSanté AfricSanté AfricSanté

Accounting and administrative support

Ms Ruffine KANDO Ms Natacha PODA Ms Chantal MILLOGO

AfricSanté Data entry clerks: carried out data entry for the RCT (Phase 2)

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