Dr Nicole Votruba is a senior postdoctoral researcher in implementation science at the Nuffield Department of Women’s & Reproductive Health, University of Oxford. She is leading the process evaluation for the SMARThealth Pregnancy programme, a large cluster RCT in rural India. Nicole is also PI of the community-based perinatal mental health (PRAMH) study in rural India, and she is co-lead of the Indigo Local study, developing a multi-country community anti-stigma campaign.
Women who experience anaemia, gestational diabetes and hypertension during the perinatal phase are at high risk of long-term complications. However, effective low-cost strategies to integrate non-communicable disease screening into pregnancy care in low-income settings are rare. SMARThealth Pregnancy (SHP2) is a hybrid type-2 effectiveness-implementation trial aiming to improve health during pregnancy and the first year after birth using a community-based, digital approach. A detailed process evaluation will be carried out to determine the implementation outcomes and strategies of the intervention, to understand the effects (or lack thereof), to clarify assumptions around causal mechanisms, and to enhance understanding on generalisability.
Aims: To (1) examine implementation outcomes, (2) identify contextual factors and mechanisms of action/impact, (3) understand mechanisms and strategies.
A mixed-methods, theory-driven process evaluation will be performed, in parallel to the main SHP2 trial for both intervention and active control arms. The mixed-methods study design will assess the process evaluation objectives. Data collection will include quantitative data collection from the digital application, health/training records, surveys, qualitative interviews and focus groups with key stakeholders, ethnographic observation, documentary analysis, and notes audit. Implementation outcomes will be assessed using the RE-AIM framework (reach, effectiveness, adoption, implementation, maintenance) and Proctor et al’s implementation outcomes typology. The effectiveness of implementation strategies will be assessed using the Expert Recommendations for Implementing Change (ERIC) compendium. Data analysis will apply mixed deductive and inductive thematic analysis.
A first round of data collection has started in Telangana and Haryana in April 2023, using interviews and focus group discussions with health care workers and women, as well as ethnographic observation. The process evaluation analysis will aim to seek explanations for outcomes achieved in the SHP2 trial. Results will be analysed across and between clusters, allowing to compare/contrast context and implementation between them and with other clusters showing similar outcomes.
This process evaluation is part of the SHP2 effectiveness-implementation study. It will inform the iterative development of a future intervention scale-up and adoption, or in case of a null trial, to understand which factors contributed