Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03576157 |
| Other study ID # |
90075552 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 7, 2018 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
September 2022 |
| Source |
Johns Hopkins Bloomberg School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
British Broadcasting Corporation (BBC) Media Action is presently implementing two large scale
mobile health (mHealth) initiatives in India: Kilkari and Mobile Academy. Kilkari is an
outbound service that delivers weekly, time-appropriate audio messages about pregnancy,
childbirth, and childcare directly to families on their mobile phones, starting from the
second trimester of pregnancy until the child is one-year-old. Mobile Academy (MA) is an
Interactive Voice Response (IVR) in-service audio training course for Accredited social
health activists (ASHAs) in India designed to refresh their knowledge of life-saving
preventative health behaviors and improve their interpersonal communications skills. Both
programs were initiated in Bihar in 2012, and have been scaled widely in a number of states
with support from Ministry of Health and Family Welfare (MOHFW) at the national level,
National Health Missions (NHM) at the state level, and an alliance of donors (Gates
Foundation, USAID, Barr Foundation, and UK Department for International Development (UKAid)).
The Johns Hopkins School of Public Health, Oxford Policy Management, and University of Cape
Town are supporting BBC Media Action and the Ministry of Health and Family Welfare (MOHFW)
are conducting an external evaluation of both Kilkari and Mobile Academy (MA). The evaluation
spans through April 2020.
Description:
The Johns Hopkins Global mHealth Initiative, Oxford Policy Management, and University of Cape
Town proposes supporting BBC Media Action and the Ministry of Health and Family Welfare
(MOHFW) to conduct an external evaluation of Mobile Academy (MA) and Kilkari. In the below
text, we outline 6 proposed activities which comprise the evaluation, which are planned from
mid 2018 to April 2020.
These studies will help inform program modification and scale-up plans, and will help better
understand the effects of maternal mobile messaging in India and globally.
1. Secondary analysis of cross-site trends in key performance indicators (Duration:
throughout study):
Mobile Academy (MA): We will use system generated data to estimate the proportion of
ASHAs who have completed MA training across 12 states. We will additionally aim to
understand linkages between ASHA's exposure to the MA training content and performance
on MA knowledge assessments.
Kilkari: We estimate that Kilkari users will have differing levels of exposure to the
program. For example, some women may not be present when the Kilkari calls come and thus
miss out on key content. Analyses of system generated data will aim to measure exposure
to Kilkari messages by content area (e.g. nutrition, family planning, etc) across 12
states where implementation has occurred to date. As part of this analysis we'll seek to
understand reasons why calls are not received, including phones being out of network,
changes in SIM cards, etc.
2. Summative evaluation of Kilkari (Period: April 2018 to December 2019) Objective: To
determine the effectiveness of mobile maternal health information messages on key health
outcomes in 4 districts of Madhya Pradesh (MP).
This objective will be carried out through an individually randomized controlled trial
initiated in early 2018. We propose conducting household surveys in all 4 study
districts among the cohort of women identified during conception, starting in March
2018. Women identified within the 5-7 month of their pregnancy, who have access to a
mobile phone, and consent to participate will be interviewed as part of baseline survey
and recruited for participation into Kilkari by 8 months of conception (this is intended
to mirror timings observed in Kilkari outreach in other states). Among individuals not
randomized to receive messages, we would propose delaying implementation for Kilkari for
a 12-month window to allow for evaluation activities to take place and additionally
glean information which is anticipated to improve the efficiency of implementation /
rollout in other areas.
3. ASHA Survey Objective: Identify factors underpinning differences Reproductive Maternal
Newborn and Child Health (RMNCH) knowledge and motivation among frontline health
workers, including exposure to the Mobile Academy training program.
As part of the baseline surveys described under activity 2 in MP, we will conduct face
to face interviews with all ASHAs (n=1,200) across the four study districts in MP. A
sub-sample will also be contacted for a follow-on phone survey a week later, to pilot
modules and validate a phone survey tool on knowledge and motivation, which can then be
applied to other ASHAs to measure key outcomes as part of MA deployments in other
states, including Rajasthan.
4. Post-natal care phone survey Objective: Measure respectful maternity care (RMC) during
childbirth, essential newborn care, and infant feeding practices within 0-3 months
postpartum As part of baseline survey activities in MP, we propose additionally
identifying women in 1-2 districts who are 0 to 3 months postpartum (n=880). Face to
face interviews with postpartum women will provide a forum to measure key infant feeding
and essential newborn care outcomes. Phone surveys, a week later, with a subset will
help develop a validated phone survey tool for their measurement amongst individuals
enrolled into Kilkari.
5. Qualitative interviews of both Kilkari and MA in MP and Rajasthan
Objectives:
Mobile Academy
• Understand stakeholder (ASHA, ASHA supervisor and beneficiary) perceptions of MA,
including barriers / facilitators underpinning uptake and completion of MA training and
enacting its content, and how it affects interpersonal communication between
stakeholders.
Kilkari
- Understand stakeholder (ASHA, ASHA supervisor and beneficiary) perceptions of
Kilkari, including different message content areas, barriers / facilitators to the
adoption of Kilkari's recommended RMNCH practices and careseeking behaviors
- Identify barriers / facilitators for pregnancy and birth registration
The qualitative research component will complement the summative evaluation and
secondary data analysis components. Qualitative research will include in-depth
interviews and focus group discussions in both MP and Rajasthan. Differentials in uptake
of MA across these settings provides a unique opportunity to understand the
characteristics of ASHAs and the larger health systems environment which contribute to
MA completion. Among Kilkari beneficiaries, qualitative research can help better
understand user perception of content, the extent and mechanism of impact of the
messages on health-related knowledge, behavior and relationships.
6. Economic evaluation of Kilkari Objective: To determine the incremental
cost-effectiveness of Kilkari as compared to a null scenario of no messages To estimate
the value for money of Kilkari, we will estimate the costs of program to all key
stakeholders involved-including BBC Media Action, MOHFW, and end-users. To estimate the
effects of the program on health outcomes, we will draw from household survey data at
baseline and endline amongst individuals exposed and not exposed to messages. Data on
changes in careseeking for antenatal care as well the adoption of practices around
breastfeeding and family planning will be inputted into the Lives Saved Tool to generate
a measure of lives saved associated with program activities. Lives saved will be used to
yield an estimate of the incremental Disability-Adjusted Life Years (DALY) averted and
ultimately a cost per DALY averted.
