Condition category
Infections and Infestations
Date applied
19/11/2018
Date assigned
11/02/2019
Last edited
11/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
North West Nigeria has one of the highest fertility rates (6.7 births per woman (Demographic and Health Survey 2013)) and lowest vaccination rates in the world (UNICEF 2017). The most recent National Immunization Coverage Survey in 2011 found that only about 1 in 20 12- to 23-month-olds in the North West states of Katsina and Zamfara, respectively, had received all recommended childhood vaccines. Low immunization rates contribute to Nigeria’s high death rate in children aged under 5 years (104 deaths per 1,000 live births). Two in five of deaths in this age group in Nigeria are from diseases that are preventable through vaccination. The region of North West Nigeria has particularly low levels of vaccination and has had frequent measles outbreaks. It is also one of the world’s last locations where polio has not been eliminated.
Aid organizations have improved the infrastructure for routine immunization, but vaccination rates remain low. The World Health Organization's global immunization coverage target is 9 out of 10 children. Over half of people who either never vaccinated their children or skipped certain vaccinations said 'lack of knowledge' or 'ambivalence' (not knowing whether it was positive or negative) was the main reason for not vaccinating their children. For those who skipped one or more routine vaccinations, access and service delivery issues were a barrier. People who did vaccinate their child at least once were likely to say that health concerns were the main reason for doing so. People who had their child fully immunized said it was because they wanted to prevent illness, disease or death, rather than because of influence from community leaders or family members.
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 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 is taking place in Jigawa, Katsina, and Zamfara States between August 2017 and January 2020.

Who can participate?
Children aged 0 to 16 months living in the catchment areas of the clinics taking part in the study.

What does the study involve?
Eligible caregivers who bring their infant(s) to the health facility for immunizations are first enrolled in the program by New Incentives staff, who record caregiver and infant details. To be eligible for the program, infants must have received one of the routine vaccinations at the clinic – this is checked against the child’s health card. 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. 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.

What are the possible benefits and risks of participating?
Those who participate in the trial and are in the New Incentives arm will benefit from the cash payments. All data is anonymized and stored securely. The children will benefit from being protected from common infectious diseases, but might experience soreness at the injection site. There is a risk that by paying carregivers to vaccinate children, there might be a reduction in their motivation to get the children vaccinated for health reasons. The study will investigate this by asking caregivers for their attitudes towards vaccination at the start and end of the trial. They will also be asked if they would still vaccinate children if there was no incentive.

Where is the study run from?
IDInsight West Africa (Senegal)

When is the study starting and how long is it expected to run for?
June 2017 to November 2019

Who is funding the study?
GiveWell (USA)

Who is the main contact?
1. Zack Devlin-Foltz (public contact)
zack.devlinfoltz@idinsight.org
2. Alison Connor (public contact)
alison.connor@idinsight.org

Trial website

Contact information

Type

Public

Primary contact

Mr Zack Devlin-Foltz

ORCID ID

Contact details

IDInsight West Africa
Route de l'aéroport
Rue NG-89
Ngor - Dakar
Dakar
-
Senegal
+221 (0)77 232 11 80; +1 (0)301-466-5034
zack.devlinfoltz@idinsight.org

Type

Public

Additional contact

Dr Alison Connor

ORCID ID

Contact details

Hurlingham Park
A5
Argwings Kodhek Road
Nairobi
Nairobi
-
Kenya
-
alison.connor@idinsight.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized evaluation of All Babies are Equal - a conditional cash transfer for routine childhood immunization in north-west Nigeria

Acronym

Study hypothesis

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.

Ethics approval

1. National Health Research Ethics Committee of Nigeria, 07/08/2017, NHREC/01/01/2007-07/08/2017
2. National Health Research Ethics Committee of Nigeria, 11/08/2018, NHREC/01/01/2007-11/11/2018B (extension)

Study design

Cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

No participant information sheet available.

Condition

Prevention of tuberculosis (BCG vaccine); diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae Type B (Pentavalent Vaccine), pneumococcal bacteria (PCV vaccine), measles, rotavirus, polio, yellow fever

Intervention

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. 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 cash incentives are offered to caregivers who bring their child for vaccination at a program clinic. 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. New Incentives has a team of field officers responsible for disbursing incentives to caregivers. On each vaccination day, the field officers check vaccine quality and stock, and then prepare to disburse incentives. Incentives are paid in cash by a New Incentives staff member who also ensures the infant meets the eligibility criteria outlined above.
We plan to limit our interaction and follow-ups to the duration of the evaluation (scoping to endline). Our (researchers' and implementers') interactions with participants (caregivers and infants) consist of census and immunization surveys and cash disbursements. The last of these interactions will be the endline immunization survey, which will be conducted between November 2019 and January 2020. New Incentives (the implementer) will continue to offer cash disbursements for some period after that (with exact duration dependent on whether the evaluation results justify scale-up). However, these disbursements will not be part of the study we wish to register with you as they will occur after final data is collected.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. The odds that a 12- to 16-month-old in a community served by a program clinic received BCG
2. The odds that a 12- to 16-month-old in a community served by a program clinic received at least one dose of PENTA
3. The odds that a 12- to 16-month-old in a community served by a program clinic received Measles 1

Data collection 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). We sample these age groups as they are well beyond the age at which children should receive the program vaccinations. (The Nigerian Routine Immunization schedule aims to give the vaccinations we measure between birth and 9 months old.) We do not follow the same infants from baseline to midline to endline but, rather, compare coverage rates in the same age group at each point in time.

Secondary outcome measures

1. The odds that a 12- to 16-month-old in a community served by a program clinic is fully immunized (loose and strict)
2. The timeliness of vaccination, particularly for Measles 1, among 12- to 16-month-olds in communities served by a program clinic
3. The average number of vaccines received per 12- to 16-month-old child in communities served by a program clinic
4. The percentage of 12- to 16-month-olds in communities served by a program clinic who received at least one injectable vaccine

Data collection 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). We sample these age groups as they are well beyond the age at which children should receive the program vaccinations. (The Nigerian Routine Immunization schedule aims to give the vaccinations we measure between birth and 9 months old.) We do not follow the same infants from baseline to midline to endline but, rather, compare coverage rates in the same age group at each point in time.

Overall trial start date

01/06/2017

Overall trial end date

01/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

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

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

7500

Participant exclusion criteria

1. Residence outside the study area (self-reported)
2. Outside the age range (self-reported)

Recruitment start date

01/07/2018

Recruitment end date

01/11/2018

Locations

Countries of recruitment

Nigeria

Trial participating centre

Primary Health Care facilities across the study area.
Zamfara, Katsina, Jigawa states
various
n/a
Nigeria

Sponsor information

Organisation

GiveWell

Sponsor details

182 Howard Street #208
San Francisco
94105
United States of America
+1 (0)415 689 5803
info@givewell.org

Sponsor type

Charity

Website

https://www.givewell.org/

Funders

Funder type

Charity

Funder name

GiveWell

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results to be published on the funder's website: https://www.givewell.org/

IPD sharing statement:
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))

Intention to publish date

01/06/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/02/2019: Uploaded statistical analysis plan.