Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas

Immunization Coverage Clinical Trial

— GEVaP  

Official title:

Mobile Nudges to Increase Early Vaccination Coverage in Rural Areas: A Pilot Investigation in Ghana's Northern Region

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797950
• Other study ID #: GHS-ERC008/07/18
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 9, 2019

Study information

• Verified date: March 2020
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: July 9, 2019
• Est. primary completion date: July 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Immunization Coverage

Intervention

Behavioral:
• Voice Reminder (Group A)
Woman with a recent delivery will be contacted via mobile phone by a central study staff member to encourage them to vaccinate their newborn with OPV0 and BCG, and information on where and when vaccines are available in this community will be provided. Community volunteers will receive small incentives for documenting births in the community.
• Cash Incentive (Group B)
Mobile phone based monetary incentives will be provided to community volunteers and to women with a recent delivery who vaccinate newborns with OPV0 and BCG on time. Community volunteers will receive small incentives for documenting births in the community.

Locations

Country	Name	City	State
Ghana	Innovations for Poverty Action	Tamale	Karaga

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Innovations for Poverty Action

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Birth documentation and reporting coverage	Percentage of live births in the community during the study which are documented and reported by community health volunteers	First month of life
Primary	Full on time early vaccination coverage (OPV0 and BCG)	Percentage of infants born during study who received both BCG and OPV0 vaccinations on time (OPV0 within first 2 weeks of life and BCG within first month of life)	First month of life
Secondary	On time BCG coverage	Percentage of infants who received BCG vaccination on time (within first month of life)	First month of life
Secondary	On time OPV coverage	Percentage of infants born during study who received OPV0 on time (within first two weeks of life)	First two weeks of life (14 days)