A Hybrid, Effectiveness-implementation Research Study Protocol Targeting Antenatal Care Providers to Provide Female Genital Mutilation Prevention and Care Services in Guinea, Kenya and Somalia

Background: In settings with high prevalence of female genital mutilation (FGM), the health sector could play a bigger role in its prevention and care of women and girls who have undergone this harmful practice. However, ministries of health lack clear policies, strategic plans or dedicated funding to implement anti-FGM interventions. Along with limited relevant knowledge and skills to prevent the practice of FGM and care for girls and women living with FGM, health providers have limited interpersonal communication skills and self-efficacy, while some may have supportive attitudes towards FGM and its medicalization. We propose to test the effectiveness of a health system strengthening intervention that includes training antenatal care (ANC) providers on person-centred communication (PCC) for FGM prevention.

Methods: This will be a two-level, hybrid, effectiveness-implementation research study using a cluster randomized trial design in Guinea, Kenya and Somalia conducted over a 6 months period. In each country, within pre-selected regions/counties, 60 ANC clinics will be randomized to intervention and control arms. At baseline, all clinics will receive the level one intervention involving provision of FGM-related clinical guidelines and handbook as well as anti-FGM policies and posters. At month 3, intervention clinics will receive the level two intervention comprising of a training for ANC providers on PCC to challenge their FGM-related attitudes and build their communication skills to effectively provide FGM prevention counselling. A process evaluation will be conducted to understand 'how' and 'why' the intervention package achieves intended results. Multi-level regression modelling will be used for quantitative data analysis while qualitative data will be assessed using thematic content analysis to determine the effectiveness, feasibility and acceptability of the different intervention levels.

Discussion: The proposed study will strengthen the knowledge base regarding how to effectively involve health providers in FGM prevention and care.

Trial Registration: Trial registration and date: PACTR201906696419769 (June 3rd, 2019).