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Evaluation of an Infant Immunization Encouragement Program in Nigeria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03870061
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
New Incentives
All Babies are Equal Initiative
Information provided by (Responsible Party):
Zack Devlin-Foltz, IDinsight

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE July 1, 2018
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • The odds 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 ]
  • The odds 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 ]
  • The odds 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • The odds 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of an Infant Immunization Encouragement Program in Nigeria
Official Title  ICMJE Randomized Evaluation of a Conditional Cash Transfer Program for Routine Immunizations of Infants in Nigeria
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.
Primary Purpose: Prevention
Condition  ICMJE
  • Tuberculosis
  • Diphtheria
  • Tetanus
  • Pertussis
  • Hepatitis B
  • Haemophilus Influenzae Type b Infection
  • Pneumonia, Bacterial
  • Measles
  • Rotavirus Infections
  • Polio
  • Yellow Fever
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Control
  • Experimental: Treatment
    This arm receives the full New Incentives' conditional cash transfer program (All Babies Are Equal Initiative).
    Intervention: Behavioral: All Babies Are Equal Initiative (conditional cash transfer program)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2020)
5187
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2019)
7500
Actual Study Completion Date  ICMJE February 20, 2020
Actual Primary Completion Date February 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months to 16 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03870061
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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))

Responsible Party Zack Devlin-Foltz, IDinsight
Study Sponsor  ICMJE GiveWell
Collaborators  ICMJE
  • New Incentives
  • All Babies are Equal Initiative
Investigators  ICMJE
Study Director: Alison Connor, PhD IDinsight
PRS Account GiveWell
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP