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An mHealth intervention to improve vaccination uptake and other health outcomes among rural Indian children: pilot study for a cluster-randomized trial

An mHealth intervention to improve vaccination uptake and other health outcomes among children 0 to 12 months of age in rural Uttar Pradesh, India: pilot study for a cluster-randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44840759
Enrollment
400
Registered
2018-05-02
Start date
2018-01-19
Completion date
Unknown
Last updated
2023-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child health Infections and Infestations

Interventions

The target populations reside in resource-poor rural areas with lagging health indicators, weak health services, and low levels of health knowledge and awareness. The study interventions offer social
however, interventions are open to all village residents. The interventions include educational capsules in entertaining formats (edutainment) broadcast via mobile phone and community mobilisation.

Sponsors

Centre de recherche du Centre Hospitalier de l'Université de Montréal
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria for clusters (villages): 1. Have less than 4000 inhabitants 2. Located in Bawan Block, Hardoi district, UP. Inclusion criteria for participants: 1. Baseline/endline: Primary caregivers (usually mothers) of children 0 to 12 months of age residing in a study village. 2. Survey: Households containing a child in the age range 0-12 months. 3. Interventions: resident of selected villages.

Exclusion criteria

Exclusion criteria: 1. Not able to understand and speak Hindi or Urdu 2. Do not intend to reside in the village for the study duration (6 months)

Design outcomes

Primary

MeasureTime frame
The primary aim of this pilot study is to assess the feasibility of the planned main study. We will view the study as feasible if the following ex-ante criteria are met: 1. Recruitment and randomisation are feasible if: (i) 70% of villages approached agree to participate and accept randomisation; (ii) in participating villages, 70% of households with children in the target age range agree to participate and accept randomisation. Criteria related to recruitment and randomisation are assessed using data collected from project administrative records at study baseline (Week 0). 2. Interventions are feasible if uptake is sufficient to demonstrate acceptability and potential for impact, quantified as: 50% of households recruited to the study participate in interventions in some form (by listening to one or more outbound calls at home, and/ or by placing one or more calls, and/ or by attending community meetings). Participation in interventions was measured through two sources: (1) Call data were measured continuously throughout the study using the Tika Vaani interactive voice-response (IVR) system; (2) participation in community meetings was measured at community meetings taking place at Weeks 0, 4, 8, and 12. 3. Retention is feasible if 50% of households participating in the baseline survey agree to participate in the end line survey. This is assessed using data collected from project administrative records at study baseline (Week 0) and end line (after Week 13). 4. The design is feasible if the contamination proportion is below 15%. Contamination is assessed continuously throughout the study using the Tika Vaani interactive voice-response (IVR) system to identify the proportion of calls from callers outside the intervention group (i.e. control group villages, or non-study villages). The IVR system is used to identify unknown numbers and a moderator follows up on calls from non-registered callers to identify

Secondary

MeasureTime frame
1. Implementation fidelity is assessed by evaluating: (i) whether the activities are implemented as planned (content), (ii) whether the number of planned activities and the selected territory are respected (coverage) and (iii) if the planned frequency and duration of the activities are respected (frequency and duration). We will also explore whether there are specific moderating factors that can explain the degree of fidelity obtained. Implementation fidelity is assessed using 5 data sources: (1) structured observation with a checklist used by each field worker to verify if planned activities are implemented as specified in terms of content, coverage, duration and frequency, continuously throughout the study; (2) semi-structured interviews with field workers involved in intervention delivery at study end line (after week 13); (3) surveys administered via mobile phone (open for completion continuously from Week 7 to Week 13); (4) semi-structured interviews with health workers and local government officials at study end line (after week 13); (5) Analysis of project documents and IVR metadata collected continuously throughout the study. 2. Acceptability, accessibility, and satisfaction of the interventions to end users is assessed using 3 data sources: baseline and end line surveys (administered at Week 0 and following Week 13), mobile phone surveys administered through the IVR (open for completion continuously from Week 7 to Week 13), and qualitative interviews (community meetings taking place at Weeks 0, 4, 8, and 12, and semi-structured exit interviews and group discussions administered after Week 13 following the end line survey). 3. Knowledge, attitudes, practices, and behaviours of end users related to child health themes addressed by the intervention are assessed using 2 data sources: baseline and end line surveys (administered at Week 0 and following Week 13), and qualitative interviews (exit interviews, group discussions) admin

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026