Evaluation of an Infant Immunization Encouragement Program in Nigeria

March 27, 2020 updated by: Zack Devlin-Foltz, GiveWell

Randomized Evaluation of a Conditional Cash Transfer Program for Routine Immunizations of Infants in Nigeria

Previous studies have shown that a small incentive can have a large impact on health behaviors like vaccinating children. New Incentives, an international non-governmental organization (NGO), aims to boost demand for immunization by offering cash incentives to caregivers who have their child vaccinated at a program clinic. In collaboration with New Incentives, IDinsight is conducting a study to see whether this approach will increase immunization in North West Nigeria. This study aims to investigate whether giving cash to caregivers in North West Nigeria who bring their infants to receive vaccination against common infections (tuberculosis, diphtheria, tetanus, pertussis, hepatitis B virus (HBV) infection, Haemophilus influenzae Type B (Hib), pneumococcal bacteria, measles, rotavirus, polio, yellow fever) increases the proportion of children who are immunized. The study's main hypothesis is that New Incentives' program will increase the percentage of children immunized with BCG, any PENTA, or Measles 1 by an average increase of at least 7-percentage points across all program clinics that share a similar profile to the clinics New Incentives will operate in at scale. The study is taking place in Jigawa, Katsina, and Zamfara States between August 2017 and January 2020.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be structured as a two-arm cluster RCT with clinics catchment areas as clusters. One arm will serve as the control (83 clinics) and will operate as the status quo, while the other arm will receive New Incentives' full program (84 clinics). This design will measure the causal effect of New Incentives' program on the likelihood of an infant receiving a vaccine. The unit of treatment and randomization is the clinic catchment, while the unit of measurement for the key outcomes is the individual infant.

Eligible caregivers who bring their infant(s) to a treatment group health facility for immunizations are first enrolled in the program by New Incentives staff, who record caregiver and infant details. If the child has received the vaccination, the caregiver receives the cash incentive, and instructions on when to return for the next vaccination and incentive payment.

Data collection of outcome measures takes place at three points (baseline, midline, and endline) using a series of self-reported surveys of caregivers, examination of the child's health card (where available) and reviewing clinic records. Baseline was completed between August and October 2017, midline is scheduled for March 2019, and endline is planned for November 2019 to January 2020. Across all outcome measurements, sampled infants will be aged between 12 and 16 months (though baseline surveyed some infants aged up to 24 months to increase sample size). These age groups are sampled as they are well beyond the age at which children should receive the program vaccinations. (The Nigerian Routine Immunization schedule aims to give the program vaccinations between birth and 9 months old.) IDinsight does not follow the same infants from baseline to midline to endline but, rather, compares coverage rates in the same age group at each point in time. From the perspective of the participant, taking part in the study involves receiving a researcher into their home, providing informed consent, and answering a 1-hour survey.

Study Type

Interventional

Enrollment (Actual)

5187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Jigawa
      • Various Cities, Jigawa, Nigeria
        • Primary Health Care facilities across Jigawa State
    • Katsina
      • Various Cities, Katsina, Nigeria
        • Primary Health Care facilities across Katsina State
    • Zamfara
      • Various Cities, Zamfara, Nigeria
        • Primary Health Care facilities across the Zamfara State

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 0 to 16 months can be enrolled in the program and incentives paid to their caregivers
  • Children aged 12 to 16 months will have their data measured at endline
  • All participants must reside in study clinic catchment areas.
  • Vaccination status will be measured by caregiver survey. Caregivers must consent to the survey

Exclusion Criteria:

  • Residence outside the study area (self-reported)
  • Outside the age range (self-reported)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Treatment
This arm receives the full New Incentives' conditional cash transfer program (All Babies Are Equal Initiative).
Behavioral: All Babies Are Equal Initiative (conditional cash transfer program)
New Incentives, an NGO, offers cash incentives to caregivers for bringing their child to clinics for the first five visits of the Nigerian Routine Immunization schedule. These small cash transfers can provide some material benefit to new caregivers from poor communities. At a minimum, they help offset time and transport costs. The following vaccines are directly incentivized by the New Incentives' program: tuberculosis (BCG vaccine); diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae Type B (Pentavalent Vaccine), pneumococcal bacteria (PCV vaccine), measles vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The probability that a 12- to 16-month-old in a community served by a study clinic received BCG (based on caregivers' report of their child's vaccination history)
Time Frame: 12 to 16 months after birth
12 to 16 months after birth
The probability that a 12- to 16-month-old in a community served by a study clinic received at least one dose of PENTA (based on caregivers' report of their child's vaccination history)
Time Frame: 12 to 16 months after birth
12 to 16 months after birth
The probability that a 12- to 16-month-old in a community served by a study clinic received Measles 1 (based on caregivers' report of their child's vaccination history)
Time Frame: 12 to 16 months after birth
12 to 16 months after birth

Secondary Outcome Measures

Outcome Measure
Time Frame
The probability that a 12- to 16-month-old in a community served by a study clinic is fully immunized (loose and strict) (based on caregivers' report of their child's vaccination history)
Time Frame: 12 to 16 months after birth
12 to 16 months after birth
The timeliness of vaccination, particularly for Measles 1, among 12- to 16-month-olds in communities served by a study clinic (based on caregivers' report of their child's vaccination history)
Time Frame: 12 to 16 months after birth
12 to 16 months after birth
The average number of vaccines received per 12- to 16-month-old child in communities served by a study clinic (based on caregivers' report of their child's vaccination history)
Time Frame: 12 to 16 months after birth
12 to 16 months after birth
The percentage of 12- to 16-month-olds in communities served by a study clinic who received at least one injectable vaccine (based on caregivers' report of their child's vaccination history)
Time Frame: 12 to 16 months after birth
12 to 16 months after birth
The probability that a 12 to 16-month old in a community served by a study clinic received at least one dose of PCV?
Time Frame: 12 to 16 months after birth
12 to 16 months after birth
The change over time in the volume of BCG, Penta 1, Penta 2, Penta 3, and Measles vaccinations recorded in clinic administrative records between treatment and control
Time Frame: 12 to 16 months after birth
12 to 16 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GiveWell

Collaborators

New Incentives
All Babies are Equal Initiative

Investigators

  • Study Director: Alison Connor, PhD, IDinsight

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

All participant-level data is anonymized through removing any information that could lead to back-tracking the identity of the respondent - each respondent is allocated a random identification number in place of their name. Anonymized data are currently stored in a password-protected repository on IDinsight's Dropbox site. Access is restricted to IDinsight staff that are on the project.

IDinsight and New Incentives collect various clinic-level data as well for use as covariates and to inform operational decisions. These data are stored in the same repositories and in New Incentives' own password-protected internal dashboard.

Requests for access to data can be made directly to IDinsight (Manager: Zack Devlin-Foltz (zack.devlinfoltz@idinsight.org) and Corresponding Investigator: Dr. Niklas Heusch (niklas.heusch@idinsight.org))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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