Condition category
Infections and Infestations
Date applied
20/07/2008
Date assigned
25/07/2008
Last edited
25/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Esther Duflo

ORCID ID

Contact details

Massachusetts Institute of Technology (MIT)
Department of Economics
E52-252g
50 Memorial Drive
Cambridge
MA02142
United States of America
+1 617 258 7013
eduflo@mit.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MIT COUHES protocol: 0503001143

Study information

Scientific title

Improving immunisation coverage in rural India: A clustered randomised controlled evaluation of immunisation campaigns with and without incentives

Acronym

Study hypothesis

1. Regular monthly immunisation can increase immunisation uptake in a low immunisation set-up for children and pregnant women
2. Small incentives can further increase immunisation rate

Ethics approval

USA: Massachusetts Institute of Technology Committee on the Use of Humans as Experimental Subjects. Date of approval: 04/14/2005 (Protocol number 0503001143, renewed yearly)
India: Vidya Bhawan Board of Ethics. Date of approval: 04/05/2005 (IRB code: IRB00002646; Federal-wide Assurance code: FWA00003656; Application 04-01)

Study design

Clustered, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Immunisation against tuberculosis, diphtheria, pertussis, tetanus and polio

Intervention

134 villages in rural Udaipur were randomised to one of 3 groups:
1. A once-monthly reliable immunisation camp (intervention A; 30 villages)
2. A once-monthly reliable immunisation camp with small incentives (lentils and metal plates for completed immunization; intervention B; 30 villages)
3. Control (no intervention, 74 villages)

The vaccine package administered in this study is the World Health Organization (WHO)/UNICEF Extended Package of Immunization (EPI), which is the package provided by the Indian government. For children, the EPI includes one dose of BCG vaccine, three doses of DPT vaccine, three doses of OPV, and one dose of measles vaccine. A child should be fully immunised (i.e. have received all the EPI vaccines) by age one year.

Intervention A ("immunisation camps") establishes regular availability of immunisation services. It consists of a mobile immunisation team including a nurse and assistant (both hired by a local NGO, Seva Mandir) who conducts monthly immunisation camps in the villages. The nurse and assistant hold the camp on a fixed date every month at a fixed time (11 AM to 2 PM). The presence of the nurse and assistant is verified by the requirement of timed and dated pictures of them in the villages, and by regular monitoring. In addition, in each village, a social worker is responsible for identifying children, informing mothers about the availability of the immunisation camps, and educating them about the benefits of immunisation.

Intervention B uses the same immunisation camp infrastructure as intervention A, but in addition offered parents one kilogram of lentils per immunisation administered, and a set of thalis (metal plates used for meals) upon completion of a child's full immunisation. The value of the lentils is about Rs 40 (less than one dollar), equivalent to three quarters of one day's wage.

30 households were randomly selected in each study villages, and in 60 neighbouring villages, and all children aged 0 to 7 at the time of endline were surveyed.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Proportion of children receiving part or all of the EPI in intervention A, B and control villages. The main analysis reported in this study focuses on children aged 1- 3 at endline (i.e. eligible and old enough to be fully immunised), and the proportion of pregnant women receiving tetanus immunisation and booster.

Secondary outcome measures

Proportion of children receiving part or all of the EPI in neighbouring villages (hamlets neighbouring intervention A and intervention B camps, differences between these two groups of neighbouring hamlets and the control group, and relative risks). The main analysis reported in this study focuses on children aged 1- 3 at endline (i.e. eligible and old enough to be fully immunised), and the proportion of pregnant women receiving tetanus immunisation and booster, as for the intervention and control villages (see Primary outcome measures).

Overall trial start date

05/01/2005

Overall trial end date

05/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Participants must:
1. Be children under five years of age
2. Not have already received all of the following vaccinations: tuberculosis (BCG), diphtheria-pertussis-tetanus (DPT1, DPT2, DPT3), oral polio vaccine (OPV1, OPV2, OPV3), measles and measles booster
3. Be brought to an immunisation camp to be immunised by a parent or guardian

OR Participants included in the study must:
1. Be pregnant
2. Not have already received both the tetanus and tetanus booster vaccinations
3. Voluntarily attend an immunisation camp run in the village

Anybody meeting this condition is eligible for immunisation in all intervention villages (regardless of residence) and for incentives in intervention B villages.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

At least 9,000 children immunised. 6,000 children surveyed.

Participant exclusion criteria

Children older than 5, since immunisation has been shown to be most effective for children under 5

Recruitment start date

05/01/2005

Recruitment end date

05/01/2007

Locations

Countries of recruitment

India

Trial participating centre

Massachusetts Institute of Technology (MIT)
Cambridge
MA02142
United States of America

Sponsor information

Organisation

Abdul Latif Jameel Poverty Action Lab, Massachusetts Institute of Technology (MIT) (USA)

Sponsor details

Department of Economics
E60-275
30 Memorial Drive
Cambridge
MA02142
United States of America
+1 617 324 3852
povertyactionlab@mit.edu

Sponsor type

University/education

Website

http://www.povertyactionlab.com

Funders

Funder type

Charity

Funder name

Funding for interventions:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dorabji Tata Trust (http://www.dorabjitatatrust.org) (India) through a grant to Seva Mandir (the implementing non-governmental organisation; http://www.sevamandir.org)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Funding for data collection and analysis:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Data Collection: The John D. and Catherine T. MacArthur Foundation (http://www.macfound.org) (USA) through a grant to the Abdul Latif Jameel Poverty Action Lab, Department of Economics at the Massachusetts Institute of Technology (MIT) (http://www.povertyactionlab.org). Grant ref: 05-84892-000-GS

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Abdul Latif Jameel Poverty Action Lab, Department of Economics at the MIT (USA), for data analysis and report writing (self-funding by lead researcher's organisation). MIT Subaward Agreement for this project: #5710001713

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20478960

Publication citations

  1. Results

    Banerjee AV, Duflo E, Glennerster R, Kothari D, Improving immunisation coverage in rural India: clustered randomised controlled evaluation of immunisation campaigns with and without incentives., BMJ, 2010, 340, c2220.

Additional files

Editorial Notes