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Protocol for a process and implementation evaluation of the SMARThealth pregnancy hybrid type 2 cluster randomised

Nicole Votruba^1,2, Sreya Majumdar³, Sudhir Thout Raj³

¹Nuffield Department of Women's & Reproductive Health, University of Oxford, UK.

Women'S Health (London, England)

|March 2, 2026

Abstract

Background:

This protocol outlines the process and implementation evaluation of the SMARThealth Pregnancy (SHP) pragmatic, type 2 hybrid cluster randomised trial conducted in two states in India (Haryana/Telangana). The SHP trial aims to improve the community-level identification, diagnosis, referral and management of women with anaemia, diabetes, and hypertension during pregnancy and in the year after birth.

Objectives:

The process and implementation evaluation aims to understand how, why, and for whom the SHP intervention may be effective (or not). It aims to identify contextual factors, barriers, and facilitators relevant to the implementation of the intervention, and understand mechanisms and strategies employed during its implementation.

Design:

The study utilised a process evaluation design.

Method:

A mixed methods evaluation drawing from realist evaluation, normalisation process theory, the Medical Research Council framework, reach, effectiveness, adoption, implementation and maintenance framework, and Proctor's typology will be employed for understanding the implementation process. The evaluation will involve focus group discussions and semi-structured interviews with healthcare providers (Accredited Social Health Activist, primary care doctors, and auxiliary nurse midwife), women, and field staff. Quantitative process data describing reach, fidelity, dose, and adoption of intervention will be collected. Observations of trial setup and implementation will be conducted. Both qualitative and quantitative data will be analysed iteratively before the effectiveness outcomes of the SHP trial are available and will subsequently be triangulated with the trial primary outcome evaluation data.

Discussion:

The findings from this process evaluation will provide an understanding of how the intervention works in practice, its potential to detect and manage anaemia, diabetes and hypertension during pregnancy and in the year after birth, and its scalability as an integrated model for the management of non-communicable diseases in pregnancy/postnatal care.

Keywords:

anaemia clinical decision support community health workers complex intervention gestational diabetes mHealth maternal health non-communicable diseases preeclampsia rural India

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