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).

Cluster randomised trial of a health system strengthening approach applying person-centred communication for the prevention of female genital mutilation in Guinea, Kenya and Somalia.

INTRODUCTION: There is limited evidence on effective health systems interventions for preventing female genital mutilation (FGM). This study tested a two-level intervention package at primary care applying person-centred communication (PCC) for FGM prevention. METHODS: A cluster randomised trial was conducted in 2020-2021 in 180 antenatal care (ANC) clinics in Guinea, Kenya and Somalia. At baseline, all clinics received guidance and materials on FGM prevention and care; at month 3, ANC providers at intervention sites received PCC training. Data were collected from clinic managers, ANC providers and clients at baseline, month 3 and month 6 on primary outcomes, including delivery of PCC counselling, utilisation of level one materials, health facility preparedness for FGM prevention and care services and secondary outcomes related to clients' and providers' knowledge and attitudes. Data were analysed using multilevel and single-level logistic regression models. RESULTS: Providers in the intervention arm were more likely to deliver PCC for FGM prevention compared with those in the control arm, including inquiring about clients' FGM status (adjusted OR (AOR): 8.9, 95% CI: 6.9 to 11.5; p<0.001) and FGM-related beliefs (AOR: 9.7, 95% CI: 7.5 to 12.5; p<0.001) and discussing why (AOR: 9.2, 95% CI: 7.1 to 11.9; p<0.001) or how (AOR: 7.7, 95% CI: 6.0 to 9.9; p<0.001) FGM should be prevented. They were more confident in their FGM-related knowledge (AOR: 7.0, 95% CI: 1.5 to 32.3; p=0.012) and communication skills (AOR: 1.8; 95% CI: 1.0 to 3.2; p=0.035). Intervention clients were less supportive of FGM (AOR: 5.4, 95% CI: 2.4 to 12.4; p<0.001) and had lower intentions of having their daughters undergo FGM (AOR: 0.3, 95% CI: 0.1 to 0.7; p=0.004) or seeking medicalised FGM (AOR: 0.2, 95% CI: 0.1 to 0.5; p<0.001) compared with those in the control arm. CONCLUSION: This is the first study to provide evidence of an effective FGM prevention intervention that can be delivered in primary care settings in high-prevalence countries. TRIAL REGISTRATION AND DATE: PACTR201906696419769 (3 June 2019).

The feasibility, acceptability, appropriateness and impact of implementing person-centered communication for prevention of female genital mutilation in antenatal care settings in Guinea, Kenya and Somalia.

BACKGROUND: There is limited evidence on how to engage health workers as advocates in preventing female genital mutilation (FGM). This study assesses the feasibility, acceptability, appropriateness and impact of a person-centered communication (PCC) approach for FGM prevention among antenatal care (ANC) providers in Guinea, Kenya and Somalia. METHODS: Between August 2020 and September 2021, a cluster randomised trial was conducted in 180 ANC clinics in three countries testing an intervention on PCC for FGM prevention. A process evaluation was embedded, comprising in-depth interviews (IDIs) with 18 ANC providers and 18 ANC clients. A qualitative thematic analysis was conducted, guided by themes identified a priori and/or that emerged from the data. RESULTS: ANC providers and clients agreed that the ANC context was a feasible, acceptable and appropriate entry point for FGM prevention counselling. ANC clients were satisfied with how FGM-related information was communicated by providers and viewed them as trusted and effective communicators. Respondents suggested training reinforcement, targeting other cadres of health workers and applying this approach at different service delivery points in health facilities and in the community to increase sustainability and impact. CONCLUSION: These findings can inform the scale up this FGM prevention approach in high prevalence countries.