Table 1 Implementation outcomes to be assessed

Reach

The number of people and percent of the target population who are impacted, and the extent to which those reached are representative and include those at most risk

Size of the target population

PHC records

Study end

Number of women enrolled in the study and the number receiving the intervention

SHP app

Study end

Comparison of characteristics of the individuals enrolled in the study to the target population

SHP app; district records

Study end

Effectiveness

A measure of the impact on health individual-level primary outcome including positive, negative and unintended consequences

The proportion of women with anaemia as measured by capillary test at 12 months after birth

The proportion of women with follow-up blood pressure measurement or blood glucose tests during the 12 months after birth following a pregnancy affected hypertension or diabetes

Endline CRF

Study end

The proportion of screening visits performed per protocol (maximum 7 SHP visits)

The proportion of visits conducted in person and by phone

The proportion of visits performed at the stated time in the protocol

Intervention group only: SHP app

Study end

Self-report rating of health outcome (WHO-5 quality of life)

Endline CRF

Study end

Self-report rating of health behaviour (WHO infant feeding questionnaire)

Endline CRF

Study end

Quantitative comparison of outcomes across subgroups (family income, caste stratification, parity, rural/semi-rural, private/ government delivery) with qualitative exploration

Endline CRF, interviews and FGDs

Study end

Adoption

The number and percent of settings/providers/interventionists who participate, and the extent to which these are representative of those who the target population will use or visit

Number of PHCs invited and the number that participate at the start of the study

Baseline study information

Study initiation

Number of participating PHCs at the end of the study

Endline study information

Study end

Comparison of participating PHCs to non-participating PHCs in the district (size, location, number of pregnant women per year, sociodemographic indicators)

Local records

Study end

Implementation

Level of adherence to programme delivery as intended, including extent to which elements are implemented and/or adapted. Cost of delivering the programme

Ethnological observation to determine fidelity to SHP intervention delivery at different timepoints throughout the programme and different study visits

Interviews and FGDs

12 months and study end

Proportion of intervention elements delivered as intended as measured by a checklist of essential elements

Checklists; Interviews and FGDs

12 months and study end

Extent and number of adaptations to original protocol (fieldnotes, protocol amendments, app changes, additional trainings)

Checklists; Interviews and FGDs

Study end

Cost of programme delivery (cost of intervention, training, materials, time-based activity costing)

Costing proforma

Study end

Maintenance

The degree to which the programme is sustained to the end of the trial (at the setting level) and to which the effects of the programme are maintained (at the individual level)

Level of intent to continue programme delivery (setting) as determined by in depth interviews with key stakeholders (PHC leads, other policy makers/local leaders) and Likert scale to community health workers and PHC doctors

Surveys; Interviews

12 months and study end

Number of health workers trained to use the intervention

Number of health workers who continue to use the intervention to study end

Reasons for health worker drop outs

Intervention group only: SHP app, interviews

Study end