Protocol for a process and implementation evaluation of the SMARThealth pregnancy hybrid type 2 cluster randomised controlled trial
Author(s)
Hirst, Jane
Type
Journal Article
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:
Process evaluation.
Method:
A mixed methods evaluation drawing from realist evaluation, Normalisation process theory, the Medical Research Council framework, RE-AIM (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 set up 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 NCDs in pregnancy/postnatal care.
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:
Process evaluation.
Method:
A mixed methods evaluation drawing from realist evaluation, Normalisation process theory, the Medical Research Council framework, RE-AIM (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 set up 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 NCDs in pregnancy/postnatal care.
Date Issued
2026-07-01
Date Acceptance
2026-02-05
Citation
Women's Health, 2026, 22 (1), pp.1-16
ISSN
1745-5057
Publisher
SAGE Publishing
Start Page
1
End Page
16
Journal / Book Title
Women's Health
Volume
22
Issue
1
Copyright Statement
© The Author(s) 2026. This article is distributed under the terms of the Creative Commons Attribution 4.0 License(https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution ofthe work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages(https://us.sagepub.com/en-us/nam/open-access-at-sage).
License URL
Identifier
10.1177/17455057261425789
Subjects
maternal health
mHealth
non-communicable diseases
anaemia
gestational diabetes
preeclampsia
community health workers
rural India
complex intervention
clinical decision support
Publication Status
Published
Date Publish Online
2026-03-02