Measuring fidelity, feasibility, costs: an implementation evaluation of a cluster-controlled trial of group antenatal care in rural Nepal
Authors: Harsha Bangura Alex , Nirola Isha , Thapa Poshan , Citrin David , Belbase Bishal , Bogati Bhawana , B.K. Nirmala , Khadka Sonu , Kunwar Lal , Halliday Scott , Choudhury Nandini , Schwarz Ryan , Adhikari Mukesh , Kalaunee S. P. , Rising Sharon , Maru Duncan , Maru Sheela 
Published: January 2020

Abstract
Background
Access to high-quality antenatal care services has been shown to be beneficial for maternal and child health. In 2016, the WHO published evidence-based recommendations for antenatal care that aim to improve utilization, quality of care, and the patient experience. Prior research in Nepal has shown that a lack of social support, birth planning, and resources are barriers to accessing services in rural communities. The success of CenteringPregnancy and participatory action women’s groups suggests that group care models may both improve access to care and the quality of care delivered through women’s empowerment and the creation of social networks. We present a group antenatal care model in rural Nepal, designed and implemented by the healthcare delivery organization Nyaya Health Nepal, as well as an assessment of implementation outcomes.

Methods
The study was conducted at Bayalata Hospital in Achham, Nepal, via a public private partnership between the Nepali non-profit, Nyaya Health Nepal, and the Ministry of Health and Population, with financial and technical assistance from the American non-profit, Possible. We implemented group antenatal care as a prospective non-randomized cluster-controlled, type I hybrid effectiveness-implementation study in six village clusters. The implementation approach allows for iterative improvement in design, making changes to improve the quality of the intervention. Assessments of implementation process and model fidelity were undertaken using a mobile checklist completed by nurse supervisors, and observation forms completed by program leadership. We evaluated data quarterly using descriptive statistics to identify trends. Qualitative interviews and team communications were analyzed through immersion crystallization to identify major themes that evolved during the implementation process.

Results
A total of 141 group antenatal sessions were run during the study period. This paper reports on implementation results, whereas we analyze and present patient-level effectiveness outcomes in a complementary paper in this journal. There was high process fidelity to the model, with 85.7% (95% CI 77.1–91.5%) of visits completing all process elements, and high content fidelity, with all village clusters meeting the minimum target frequency for 80% of topics. The annual per capita cost for group antenatal care was 0.50 USD. Qualitative analysis revealed the compromise of stable gestation-matched composition of the group members in order to make the intervention feasible. Major adaptations were made in training, documentation, feedback and logistics.

Conclusion
Group antenatal care provided in collaboration with local government clinics has the potential to provide accessible and high quality antenatal care to women in rural Nepal. The intervention is a feasible and affordable alternative to individual antenatal care. Our experience has shown that adaptation from prior models was important for the program to be successful in the local context within the national healthcare system.

Trial registration
ClinicalTrials.gov Identifier: NCT02330887, registered 01/05/2015, retroactively registered.