Health care and health status in the Udaipur district, Rajasthan: demand and supply factors in early childhood immunisation

ISRCTN	ISRCTN87759937
DOI	https://doi.org/10.1186/ISRCTN87759937
Secondary identifying numbers	MIT COUHES protocol: 0503001143

Submission date: 20/07/2008
Registration date: 25/07/2008
Last edited: 25/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Esther Duflo
Scientific

Massachusetts Institute of Technology (MIT)
Department of Economics
E52-252g
50 Memorial Drive
Cambridge
MA02142
United States of America

Phone	+1 617 258 7013
Email	eduflo@mit.edu

Study information

Study design	Clustered, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	Improving immunisation coverage in rural India: A clustered randomised controlled evaluation of immunisation campaigns with and without incentives
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	05/01/2005
Completion date	05/01/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	5 Years
Sex	Both
Target number of participants	At least 9,000 children immunised. 6,000 children surveyed.
Key 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.
Key exclusion criteria	Children older than 5, since immunisation has been shown to be most effective for children under 5
Date of first enrolment	05/01/2005
Date of final enrolment	05/01/2007

Locations

Countries of recruitment

India
United States of America

Study participating centre

Massachusetts Institute of Technology (MIT)

Cambridge
MA02142
United States of America

Sponsor information

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

Department of Economics
E60-275
30 Memorial Drive
Cambridge
MA02142
United States of America

Phone	+1 617 324 3852
Email	povertyactionlab@mit.edu
Website	http://www.povertyactionlab.com
"ROR"	https://ror.org/042nb2s44

Funders

Funder type

Charity

Funding for interventions:

No information available

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

No information available

Funding for data collection and analysis:

No information available

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/05/2010		Yes	No