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Health care and health status in the Udaipur district, Rajasthan: demand and supply factors in early childhood immunisation
ISRCTN ISRCTN87759937
DOI 10.1186/ISRCTN87759937
ClinicalTrials.gov identifier
EudraCT number
Public title Health care and health status in the Udaipur district, Rajasthan: demand and supply factors in early childhood immunisation
Scientific title Improving immunisation coverage in rural India: A clustered randomised controlled evaluation of immunisation campaigns with and without incentives
Acronym N/A
Serial number at source MIT COUHES protocol: 0503001143
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
Lay summary
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
Countries of recruitment India
Disease/condition/study domain Immunisation against tuberculosis, diphtheria, pertussis, tetanus and polio
Participants - 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.
Participants - exclusion criteria Children older than 5, since immunisation has been shown to be most effective for children under 5
Anticipated start date 05/01/2005
Anticipated end date 05/01/2007
Status of trial Completed
Patient information material
Target number of participants At least 9,000 children immunised. 6,000 children surveyed.
Interventions 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.
Primary outcome measure(s) 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 measure(s) 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).
Sources of funding Funding for interventions:
Dorabji Tata Trust (http://www.dorabjitatatrust.org) (India) through a grant to Seva Mandir (the implementing non-governmental organisation; http://www.sevamandir.org)

Funding for data collection and analysis:
1. 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
2. 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
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20478960
Contact name Prof  Esther  Duflo
  Address Massachusetts Institute of Technology (MIT)
Department of Economics
E52-252g
50 Memorial Drive
  City/town Cambridge
  Zip/Postcode MA02142
  Country United States of America
  Tel +1 617 258 7013
  Fax +1 617 253 1330
  Email eduflo@mit.edu
Sponsor Abdul Latif Jameel Poverty Action Lab, Massachusetts Institute of Technology (MIT) (USA)
  Address Department of Economics
E60-275
30 Memorial Drive
  City/town Cambridge
  Zip/Postcode MA02142
  Country United States of America
  Tel +1 617 324 3852
  Fax +1 617 253 5461
  Email povertyactionlab@mit.edu
  Sponsor website: http://www.povertyactionlab.com
Date applied 20/07/2008
Last edited 25/05/2010
Date ISRCTN assigned 25/07/2008
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