Clinical trial NCT03797950: Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas
Official title: Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas: A Pilot Investigation in Ghana's Northern Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization Coverage
Keywords: OPV
BCG
vaccine delivery
mhealth
incentives
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
First posted: 2019-01-09
Enrollment: 260
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. At the same time, access to mobile phones has increased rapidly, offering new opportunities to track and deliver health services. This research project uses these newly available mobile phone networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal effort or access to get essential vaccines. To increase documentation, investigators will train volunteers in each community to report new births via mobile phone to a central coordinator, and send small monetary rewards via mobile phone to volunteers for this reporting. To increase vaccination coverage, investigators will send reminder messages directly to mothers, and will also test small monetary rewards to volunteers and to mothers as an incentive to complete recommended vaccinations. The designs to provide vaccination encouragement will be tested through a small community randomized controlled trial in 15 selected villages in Ghana's Northern region. The primary outcome for the pilot study will be the percentage of children who received both the polio birth dose (OPV0) vaccination within two weeks of life (14 days) and the BCG vaccination within the first four weeks (28 days) of life.

Detailed description: Despite major progress made in vaccination coverage overall, timeliness of vaccines remains a key concern in many settings. Early vaccination coverage is particularly low in settings where a large share of women deliver at home, as it is the case in Ghana's Northern region, where only a minority of women seek out facilities for delivery. In Ghana, 95% of children receive BCG vaccination within the first two years of life, but only about half of these children receive the vaccine within the first 30 days after delivery. Less than 50% of children in Ghana's Northern region receive Bacillus Calmette-Guérin (BCG) vaccines within the first three months of their life, and less than 40% get polio vaccination, exposing a large number of infants to these diseases.

Recent research conducted in this region shows that the large majority of households have access to mobile phones, even in the most rural areas. this project uses mobile phone networks to simultaneously address two of the biggest bottlenecks in vaccine delivery: timely documentation of births, and lack of maternal effort or access to essential vaccines. Evidence from other low resource settings suggests that even small rewards can often result in substantial increases in vaccine uptake - investigators will test this hypothesis using mobile networks in rural areas of Northern Ghana.

The main objective of this study is to assess the extent to which mobile-phone based reminder or reward systems can increase early vaccination coverage. Investigators will assess two specific interventions through the pilot study:

1. a mobile-phone based call and text system which will be used to contact mothers to highlight the importance of early vaccinations, provide reminders (nudges) to mothers encouraging them to get their newborn vaccinated and providing information on where and when vaccinations are available in their community.
2. a community volunteer-based system that will provide small mobile credit rewards to both community volunteers and mothers for completing the early vaccinations within the first month of newborn life.

Research Hypotheses (H1-3) H1: Nudging mothers through voice and text messages will increase early vaccination coverage.

H2: Nudging mothers through community volunteers and small rewards will increase early vaccination coverage.

Given that birth documentation remains low in many parts of Ghana, investigators will also test a new community-based reporting model, under which volunteers appointed by the community will receive small rewards for reporting births that occur in their communities. Investigators will test the extent to which such a program results in successful reporting of births:

H3: Providing small mobile-phone based incentives to volunteers selected by communities for reporting births will result in accurate and timely reporting of births in rural areas.

The study is an open label cluster-randomized controlled trial with three arms: a control arm, a voice reminder arm (group A), and a cash incentive arm (group B). During the intervention phase community volunteers will be appointed to document all births in 10 randomly selected treatment communities (group A and group B), and will receive small cash rewards delivered via "mobile money" for all documented births. In each of two active treatment arms, women across five villages will be enrolled in a proactive program over a period of six months. In intervention group A, participating women will receive reminders about vaccinations recommended at birth delivered via mobile phones. In intervention group B, participating women will receive encouragement from a community-appointed volunteer to complete recommended vaccinations and community volunteers and woman will receive small cash rewards delivered via "mobile money" for completing the recommended birth dose vaccinations on time. No volunteer will be appointed to documents births in the 5 control-arm villages and no women in the 5 control-arm villages will be actively enrolled nor receive a pro-active program intervention during the intervention phase.

After the intervention phase is complete, an endline population-based household survey will be conducted in the 15 study villages (5 control, 5 treatment group A, 5 treatment group B) to evaluate the effect of the intervention programs on vaccine coverage.

Eligibility criteria: Inclusion Criteria:

* Women who have given birth to a live-born, surviving infant in the last two weeks (14 days) and reside in the community.

Exclusion Criteria:

* Women who do not reside in the community.
* Women whose newborn has passed away.

Primary outcomes:
measure: Full on time early vaccination coverage (OPV0 and BCG)
timeFrame: First month of life
Secondary outcomes:
measure: On time BCG coverage
timeFrame: First month of life
measure: On time OPV coverage
timeFrame: First two weeks of life (14 days)
Other outcomes:
measure: Birth documentation and reporting coverage
timeFrame: First month of life
Locations:
city: Tamale
country: Ghana
facility: Innovations for Poverty Action
state: Karaga
Study officials:
affiliation: Swiss Institute for Tropical and Public Health
name: Guenther Fink, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levine G, Salifu A, Mohammed I, Fink G. Mobile nudges and financial incentives to improve coverage of timely neonatal vaccination in rural areas (GEVaP trial): A 3-armed cluster randomized controlled trial in Northern Ghana. PLoS One. 2021 May 19;16(5):e0247485. doi: 10.1371/journal.pone.0247485. eCollection 2021.
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.