Evaluation of an Infant Immunization Encouragement Program in Nigeria
Primary Purpose
Tuberculosis, Diphtheria, Tetanus
Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
All Babies Are Equal Initiative (conditional cash transfer program)
Sponsored by
About this trial
This is an interventional prevention trial for Tuberculosis focused on measuring Randomized Controlled Trial, Vaccinations, Nigeria, Conditional Cash Transfers, Cash Incentives, Infants, Impact Evaluation, Immunization
Eligibility Criteria
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)
Sites / Locations
- Primary Health Care facilities across Jigawa State
- Primary Health Care facilities across Katsina State
- Primary Health Care facilities across the Zamfara State
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Treatment
Arm Description
This arm receives the full New Incentives' conditional cash transfer program (All Babies Are Equal Initiative).
Outcomes
Primary Outcome Measures
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)
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)
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)
Secondary Outcome Measures
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)
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)
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)
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)
The probability that a 12 to 16-month old in a community served by a study clinic received at least one dose of PCV?
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
Full Information
NCT ID
NCT03870061
First Posted
March 4, 2019
Last Updated
March 27, 2020
Sponsor
GiveWell
Collaborators
New Incentives, All Babies are Equal Initiative
1. Study Identification
Unique Protocol Identification Number
NCT03870061
Brief Title
Evaluation of an Infant Immunization Encouragement Program in Nigeria
Official Title
Randomized Evaluation of a Conditional Cash Transfer Program for Routine Immunizations of Infants in Nigeria
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
GiveWell
Collaborators
New Incentives, All Babies are Equal Initiative
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type b Infection, Pneumonia, Bacterial, Measles, Rotavirus Infections, Polio, Yellow Fever
Keywords
Randomized Controlled Trial, Vaccinations, Nigeria, Conditional Cash Transfers, Cash Incentives, Infants, Impact Evaluation, Immunization
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be structured as a two-arm cluster RCT. One arm (83 clinics) will serve as the control and will operate as the status quo, while the other arm (84 clinics) will receive New Incentives full program. This design will measure the causal effect of New Incentives' program on the likelihood of an infant receiving a vaccine.
New Incentives, an international non-governmental organization (NGO), is addressing the apparent shortfall in demand for immunization by offering cash incentives to caregivers for bringing their child to clinics for the first five visits of the Nigerian Routine Immunization schedule. To be eligible, the child must reside in the catchment area of the clinic and fall within the age range targeted for the vaccination in question. Infants do not need to have received the previous vaccine in the schedule to be eligible. Incentives are paid in cash by a New Incentives staff member who also ensures the infant meets the eligibility criteria outlined above.
Masking
None (Open Label)
Masking Description
Potential participants in treatment communities likely interact with implementing staff (either to receive the program, or in passing). Potential participants in control communities usually only interact with data collection staff. They are informed about the studies' general goals.
Allocation
Randomized
Enrollment
5187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Treatment
Arm Type
Experimental
Arm Description
This arm receives the full New Incentives' conditional cash transfer program (All Babies Are Equal Initiative).
Intervention Type
Behavioral
Intervention Name(s)
All Babies Are Equal Initiative (conditional cash transfer program)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
16 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Connor, PhD
Organizational Affiliation
IDinsight
Official's Role
Study Director
Facility Information:
Facility Name
Primary Health Care facilities across Jigawa State
City
Various Cities
State/Province
Jigawa
Country
Nigeria
Facility Name
Primary Health Care facilities across Katsina State
City
Various Cities
State/Province
Katsina
Country
Nigeria
Facility Name
Primary Health Care facilities across the Zamfara State
City
Various Cities
State/Province
Zamfara
Country
Nigeria
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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))
Learn more about this trial
Evaluation of an Infant Immunization Encouragement Program in Nigeria
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