Cluster randomized trial of a mHealth intervention “ImTeCHO” to improve delivery of proven maternal, neonatal, and child care interventions through community-based Accredited Social Health Activists (ASHAs) by enhancing their motivation and strengthening supervision in tribal areas of Gujarat, India: study protocol for a randomized controlled trial

This is a two-arm, parallel, stratified cluster randomized trial in which the unit of randomization is the PHC. Because this is a complex community-based intervention, a cluster randomization is required. The ImTeCHO web interface will be primarily used by the PHC staff, including the medical officer, and other support staff; thus, using the PHC as the unit of randomization will reduce contamination between clusters. A PHC is an operational and administrative unit for providing curative and public health services for all its covered villages. Each PHC has a team of two medical officers, four to six ANMs, one Lady Health Visitor, and several male multi-purpose workers. Of the two medical officers, one has an MBBS degree and is in charge of the PHC, including clinical services. The other medical officer is usually an Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy (AYUSH) practitioner and is involved in field-based duties. Each ANM is in charge of one subcenter which serves a population of 3000–4000. On an average, there are 20–25 ASHAs per PHC. There is one ASHA Facilitator for approximately every 10 ASHAs. The average size of the population per PHC is approximately 20,000 in tribal areas [16].

This study will be conducted by SEWA Rural, which is a voluntary organization located in the Jhagadia block of Gujarat. SEWA Rural has been involved in health and development activities in rural, tribal areas of Gujarat, India since 1980 [17]. The study area belongs to the tribal belt which stretches along the Satpura mountain range located along the eastern part of Gujarat. Some of the study area is covered by thick forest. The tribal population residing in the study area is called “Vasava” or “Bhil.” As with other tribal communities, the Vasava tribe has its own language and customs which are different from the mainstream culture, though this is changing rapidly as they become increasingly connected with today’s more modern culture. Agriculture is the main occupation, with a large number of the population working as landless laborers [18]. The rate of industrialization is much slower in these areas. Dediyapada, Nandod, and Sagbara belong to the Narmada district which was named one of the most backward districts by the Ministry of Panchayati Raj in 2006 due to its lack of development and difficult terrain [19]. The literacy rate of the study area was 65%, and the proportion of scheduled tribe population was 75% in a 2011 census of India.

Detailed information about the intervention is described in another publication [15]. Table 1 shows the service delivery by study arm. This is followed by a brief description of the main component of the intervention which is use of the ImTeCHO mobile and web-based application by the ASHAs, medical officers, and PHC staff.

Every ASHA is given a low-cost smartphone which will be General Packet Radio Service (GPRS)-enabled, with a multi-media feature. The mobile phone application will have the following features: home visit forms, log of case details, work log, announcements, and SMS information channel. The ASHA fills out forms on her mobile during home visits which will be sent to a server using the GPRS network. Similarly, the ANMs will be given a tablet to track high-risk cases and monitor the performance of the ASHAs. Each medical officer views a web interface which is a computer screen where organized data is available online. The ImTeCHO software organizes the data into useful information (based on predefined logic) for the PHC staff. The web interface will have features to track high-risk cases, see reports, and manage incentives and supplies. No other concomitant care and interventions, apart from that mentioned above, will be delivered by the trial team; however, other organizations cannot be prohibited from introducing new public health programs, considering the nature of the trial and implementation research. See Fig. 1 for a diagram of the three main components of the mobile and web-based application.

The control area will continue to receive usual health services from the government and other providers. All ASHAs in the control and intervention area will receive the refreshers' training described above.

Based on the information available for a sample of the study area before baseline and earlier surveys, we assumed there will be 25 ASHAs (cluster size) in a PHC and the MACCI will be 36%. In the absence of existing information regarding the intra-class correlation, we assumed the intra-class correlation coefficient (ICC) to be 0.02. Assuming a loss of one cluster per arm and three ASHAs per PHC, for detecting 15% absolute improvement in the MACCI in the intervention arm compared to the control arm at the endline survey with 80% power and a 5% two-sided significance level, we estimated the required sample size per arm to be 11 PHCs/clusters. Similarly, we assumed that 46% of neonates/mothers would receive at least two postnatal home visits within the first week of delivery by the ASHA in the control arm based on earlier surveys. Assuming the loss of one cluster per arm and three ASHAs per PHC, we estimated the required sample size per arm to be six PHCs/clusters for detecting 20% absolute improvement in the proportion of neonates/mothers who received at least two postnatal home visits within the first week of delivery by the ASHA in the intervention arm compared to the control arm at the endline survey with 80% power and a 5% two-sided significance level.

Stratification was done to ensure that the prevalence of primary outcomes would be similar in the intervention and control groups along with almost equal selection of PHCs from the most backward Dediyapada block. The randomization was done after a baseline survey. The allocation ratio was 1:1. The stratified randomization was performed by a statistician at All India Institute of Medical Sciences (AIIMS, New Delhi) who was not involved in implementation of the intervention. The baseline variable used for stratification was the primary outcome indicator; the assessment will be described in detail in a later section. The mean value of the primary outcome indicator was used as a cut-off to divide each PHC into one of the two strata. The PHCs in each of the two strata were randomly allocated into an intervention and a control group. The randomization was done using the software nQuery. Due to the nature of the community-based intervention, blinding was not possible. See the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram (Fig. 2), the Consolidated Standards of Reporting Trials (CONSORT) study flow chart (Fig. 3), and the SPIRIT checklist (Additional file 1). Additional file 2 is a copy of the information sheet and consent form. Additional file 3 shows the statistical analysis plan.

All clusters (PHCs) belonging to six high-priority tribal blocks of Bharuch and Narmada districts in Gujarat (except those where ImTeCHO is being implemented already as part of another project) having a 100% rural population and predominantly scheduled tribe population (at least 45%) were eligible to be included. Bharuch and Narmada districts were selected because both are predominantly tribal districts with several hard-to-reach, high-priority areas identified by the state government and with proximity to the lead organization conducting this study. Those PHCs were excluded where all medical officer posts and more than 20% of posts for ASHAs were vacant at the time of initiation of the study. PHCs that had more than 10% villages without GPRS (mobile connectivity) most of the time were excluded. Although the ImTeCHO mobile application can function without a GPRS signal, the lack of this signal in large areas of intervention will affect components of the intervention to a significant extent.

Household surveys will be used for assessing the above-mentioned outcomes of interest. The household survey tools are based on the District Level Household and Facility Survey (DLHFS-4) [27]. Table 3 briefly describes the measurement of outcomes.

All pregnancy registrations, their outcomes, and any neonatal and infant deaths in all clusters throughout the study period will be counted as part of the ongoing pregnancy and mortality surveillance by a separate team of data collectors. Subsequently, all respondents who will be eligible during the survey period will be enrolled for a household survey using information from the ongoing pregnancy registration and mortality surveillance, whether or not they received the intervention. The data collection team will enter data into smartphones which will be loaded with a data collection tool with built-in checks for missing data and logical inconsistency. Data will be uploaded to a central server using the GPRS. A data administrator will check for any inaccuracies, and these will be clarified during a review meeting with the data collectors. Five percent of households will be randomly selected and re-interviewed by an independent quality assurance team using a truncated questionnaire.

This study is of 3 years’ duration from March 2015 to February 2018. Table 4 shows the timeline for the study. The development of the ImTeCHO intervention and formative evaluation is already completed and documented [15].

The implementation will be delivered by an implementation team, and evaluation will be done by an evaluation team; the teams will work independently of each other. Both teams are supervised by the principal investigator through meetings held twice a month. An advisory committee consisting of independent researchers, technical experts, academicians, and government administrators meets on a regular basis.

The Data Safety and Monitoring Board comprises independent scientists, ethicists, community members, and a statistician, and they meet on a regular basis. As the outcome measurements will be done at baseline and endline only, there is no plan to do an interim analysis. There is no plan to audit the conduct of the trial.

Data analysis will be done as per the statistical analysis plan (see Additional file 3). The primary analysis will be intention to treat, and the secondary analysis would be per protocol. Data will be analyzed taking into account cluster randomization. In case of any imbalance in any of the characteristics at the cluster or at the beneficiary level, adjustments will be done using the generalized estimating equation approach. For each of the primary and secondary outcomes, the effect size (95% confidence interval), after adjustment if required, would be computed. Each outcome will be compared between the intervention and control groups at the endline. Additionally, the difference in differences technique will be used for those outcomes which were measured at baseline and endline. A before and after analysis will also be done. STATA 13.0 will be used for data analysis. The results will be presented as per the statistical analysis plan.

The Multi-institutional Ethics Committee (Mumbai), Institutional Ethics Committee of SEWA Rural, and Ethics Review Committee of the World Health Organization (Protocol ID number: MCA00615) have approved the study. Informed consent will be obtained by trained data collectors from all respondents prior to a household survey. A copy of the information sheet and consent form can be found in Additional file 2. All personally identifiable information will be removed, and unique numbers will be assigned to the participants. Only the investigators will have access to data linking personally identifiable information with the unique numbers. The proposed application will contain medical information of individuals and hence demands high levels of data security. In view of this, the application shall accept, transmit, process, and store data using prudent security and data encryption practices. The database will be protected by a password. The study is registered at the Clinical Trial Registry of India (http://​www.​ctri.​nic.​in/​Clinicaltrials/​pdf_​generate.​php?​trialid=​11820&​EncHid=​&​modid=​&​compid=​%27,%2711820det%27), and the registration number for the submitted application is CTRI/2015/06/005847. We will disseminate findings of the study with all stakeholders through various strategies, including meetings and printed and visual media and publications. The final report will follow the CONSORT 2010 guidelines and its extension for cluster trials published in 2012 and non-pharmacologic treatment interventions [28].

We need to assess the risk of some unplanned events during the course of the study which can have an impact on it. Some of the possibilities are:

If there is a major reorganization of the PHCs by the government, then dropout of selected PHCs might be inevitable. Appropriate decisions will be taken on a case-by-case basis, and records will be maintained to document actions taken.

SEWA Rural is closely working with the government and other stakeholders to mitigate or minimize these and other unanticipated risks while preserving ethical and moral values.

SEWA Rural is the lead organization. The Department of Health and Family Welfare, Government of Gujarat is implementing the intervention within the primary health care system with active facilitation by SEWA Rural. Argusoft India Ltd. and SEWA Rural are leading efforts towards development and maintenance of the ImTeCHO software.

A few nested studies are being planned during the course of the trial as follows:

The clusters were randomized in July 2015. The intervention has been implemented since February 2016 after completion of training of the ImTeCHO users.