Evaluation of an Infant Immunization Encouragement Program in Nigeria

NCT03870061 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 5,187
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  12 to 16 months after birth

Secondary Outcomes (6)

• 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)

  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)

  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)

  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)

  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?

  12 to 16 months after birth

Study Arms (2)

Control

NO INTERVENTION

Treatment

EXPERIMENTAL

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)

Interventions

All Babies Are Equal Initiative (conditional cash transfer program) BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 12 Months - 16 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• GiveWell: lead
• New Incentives: collaborator
• All Babies are Equal Initiative: collaborator

Study Sites (3)

Primary Health Care facilities across Jigawa State

Various Cities, Jigawa State, Nigeria

Location

Primary Health Care facilities across Katsina State

Various Cities, Katsina State, Nigeria

Location

Primary Health Care facilities across the Zamfara State

Various Cities, Zamfara State, Nigeria

Location

MeSH Terms

Conditions

Tuberculosis; Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Haemophilus Infections; Pneumonia, Bacterial; Measles; Rotavirus Infections; Poliomyelitis; Yellow Fever

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections; Pneumonia; Lung Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Reoviridae Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral

Study Officials

• Alison Connor, PhD

  IDinsight

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 11, 2019
• Study Start: July 1, 2018
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

NG (3)