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

Last registered on May 31, 2016

Pre-Trial

Trial Information

General Information

Title
Improving immunisation coverage in rural India: clustered randomised controlled evaluation of immunization campaigns with and without incentives
RCT ID
AEARCTR-0001193
Initial registration date
May 31, 2016

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 31, 2016, 11:19 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
MIT

Other Primary Investigator(s)

PI Affiliation
Abdul Latif Jameel Poverty Action Lab
PI Affiliation
Commonwealth Care Alliance
PI Affiliation
Department of Economics, Massachusetts Institute of Technology

Additional Trial Information

Status
Completed
Start date
2004-06-01
End date
2007-02-01
Secondary IDs
IRSCTN87759937
Abstract
OBJECTIVE: To assess the efficacy of modest non-financial incentives on immunisation rates in children aged 1-3 and to compare it with the effect of only improving the reliability of the supply of services.

DESIGN: Clustered randomised controlled study.

SETTING: Rural Rajasthan, India.

PARTICIPANTS: 1640 children aged 1-3 at end point.

INTERVENTIONS: 134 villages were randomised to one of three groups: a once monthly reliable immunisation camp (intervention A; 379 children from 30 villages); a once monthly reliable immunisation camp with small incentives (raw lentils and metal plates for completed immunisation; intervention B; 382 children from 30 villages), or control (no intervention, 860 children in 74 villages). Surveys were undertaken in randomly selected households at baseline and about 18 months after the interventions started (end point).

MAIN OUTCOME MEASURES: Proportion of children aged 1-3 at the end point who were partially or fully immunised.

RESULTS: Among children aged 1-3 in the end point survey, rates of full immunisation were 39% (148/382, 95% confidence interval 30% to 47%) for intervention B villages (reliable immunisation with incentives), 18% (68/379, 11% to 23%) for intervention A villages (reliable immunisation without incentives), and 6% (50/860, 3% to 9%) for control villages. The relative risk of complete immunisation for intervention B versus control was 6.7 (4.5 to 8.8) and for intervention B versus intervention A was 2.2 (1.5 to 2.8). Children in areas neighbouring intervention B villages were also more likely to be fully immunised than those from areas neighbouring intervention A villages (1.9, 1.1 to 2.8). The average cost per immunisation was $28 (1102 rupees, about £16 or €19) in intervention A and $56 (2202 rupees) in intervention B.

CONCLUSIONS: Improving reliability of services improves immunisation rates, but the effect remains modest. Small incentives have large positive impacts on the uptake of immunisation services in resource poor areas and are more cost effective than purely improving supply.
External Link(s)

Registration Citation

Citation
Banerjee, Abhijit Vinayak et al. 2016. "Improving immunisation coverage in rural India: clustered randomised controlled evaluation of immunization campaigns with and without incentives." AEA RCT Registry. May 31. https://doi.org/10.1257/rct.1193-1.0
Former Citation
Banerjee, Abhijit Vinayak et al. 2016. "Improving immunisation coverage in rural India: clustered randomised controlled evaluation of immunization campaigns with and without incentives." AEA RCT Registry. May 31. https://www.socialscienceregistry.org/trials/1193/history/8528
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Experimental Details

Interventions

Intervention(s)
Sample villages were randomised to one of three groups:
1) Treatment A: a once monthly reliable immunisation camp
2) Treatment B: a once monthly reliable immunisation camp with incentives of raw lentils (for each immunisation) and metal plates for completed immunization package;
3) Control with no intervention.

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. Surveys were undertaken in randomly selected households at baseline and about 18 months after the interventions started (end point).
Intervention Start Date
2005-02-01
Intervention End Date
2006-07-30

Primary Outcomes

Primary Outcomes (end points)
Proportion of children receiving part or all of the EPI vaccine in intervention A, B and control villages.
Primary Outcomes (explanation)
Mothers were surveyed about the immunisation status of all children aged under 7 years at the end point and about her immunisation status during her pregnancy with each child. Self-reported immunisation status was cross checked with BCG scar, immunisation card and immunisation camp records.

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Of 134 sample villages in Seva Mandir’s catchment area, 30 were allocated to the reliable camp arm, 30 to reliable camp and incentive arm and 74 to control arm. Camps were conducted by a mobile immunisation team including a nurse and assistant that conducted monthly immunisation camps in the villages. The nurse and assistant held the camp on a fixed date every month at a fixed time (11 AM to 2 PM). The presence of the nurse and assistant was verified by the requirement of timed and dated pictures of them in the villages, and by regular monitoring.vIn most control villages, a Seva Mandir health worker was present and encouraged uptake of preventive services, including immunisation. In all villages, the government nurse continued to provide immunisation services for the duration of the study.

When a camp was organised by Seva Mandir in a village, any non-immunised child younger than 5 years, from any village, was eligible for immunisation in the camp but only children younger than 2 were eligible for incentive (when applicable). Children who began the immunisation course before turning 2 remained eligible for the incentives until the completion of the immunisation course. Villages from all three treatment groups were sufficiently far from each other (over 20 km) to avoid contamination.
Experimental Design Details
Randomization Method
Using the random number generator in the statistical package Stata (version 9), and after stratification by geographical block (the administrative unit above the village), one author (Esther Duflo) randomly selected 30 of the 134 study villages to receive intervention A and 30 to receive intervention B. The 74 remaining villages were control villages and received no additional intervention.
Randomization Unit
Villages.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
134 villages
Sample size: planned number of observations
2,158 children
Sample size (or number of clusters) by treatment arms
1) Treatment A: 453 children from 30 villages.
2) Treatment B: 481 children from 30 villages.
3) Control: 1224 children from 74 villages.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Taking into account correlation of the end point within a village and clustering of the treatment at that level (a intracluster correlation of 0.25 was assumed based on a preliminary survey) and given a baseline immunization rate of 2% in the control group, a sample of 30 villages per treatment arm, with a random sample of 30 households per village (assuming about 1.4 children aged 1-3 years surveyed in each household), was sufficient to obtain 80% power for a 5% level test of a difference of at least five percentage points in the probability of being fully immunised between any two groups (treatment A, treatment B, and comparison).
IRB

Institutional Review Boards (IRBs)

IRB Name
Vidhya Bhawan board of ethics
IRB Approval Date
2005-04-25
IRB Approval Number
IRB00002646
IRB Name
Massachusetts Institute of Technology
IRB Approval Date
2005-04-14
IRB Approval Number
0503001143

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
July 31, 2006, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
February 01, 2007, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
128 villages
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
1,621 children
Final Sample Size (or Number of Clusters) by Treatment Arms
1) Treatment A: 379 children from 30 villages. 2) Treatment B: 382 children from 30 villages. 3) Control: 860 children in 74 villages.
Reports, Papers & Other Materials

Relevant Paper(s)

Abstract
IMPROVING IMMUNISATION COVERAGE IN RURAL INDIA: CLUSTERED RANDOMISED CONTROLLED EVALUATION OF IMMUNIZATION CAMPAIGNS WITH AND WITHOUT INCENTIVES

OBJECTIVE: To assess the efficacy of modest non-financial incentives on immunisation rates in children aged 1-3 and to compare it with the effect of only improving the reliability of the supply of services.

DESIGN: Clustered randomised controlled study.

SETTING: Rural Rajasthan, India.

PARTICIPANTS: 1640 children aged 1-3 at end point.

INTERVENTIONS: 134 villages were randomised to one of three groups: a once monthly reliable immunisation camp (intervention A; 379 children from 30 villages); a once monthly reliable immunisation camp with small incentives (raw lentils and metal plates for completed immunisation; intervention B; 382 children from 30 villages), or control (no intervention, 860 children in 74 villages). Surveys were undertaken in randomly selected households at baseline and about 18 months after the interventions started (end point).

MAIN OUTCOME MEASURES: Proportion of children aged 1-3 at the end point who were partially or fully immunised.

RESULTS: Among children aged 1-3 in the end point survey, rates of full immunisation were 39% (148/382, 95% confidence interval 30% to 47%) for intervention B villages (reliable immunisation with incentives), 18% (68/379, 11% to 23%) for intervention A villages (reliable immunisation without incentives), and 6% (50/860, 3% to 9%) for control villages. The relative risk of complete immunisation for intervention B versus control was 6.7 (4.5 to 8.8) and for intervention B versus intervention A was 2.2 (1.5 to 2.8). Children in areas neighbouring intervention B villages were also more likely to be fully immunised than those from areas neighbouring intervention A villages (1.9, 1.1 to 2.8). The average cost per immunisation was $28 (1102 rupees, about £16 or €19) in intervention A and $56 (2202 rupees) in intervention B.
Citation
Banerjee, Abhijit Vinayak, Esther Duflo, Rachel Glennerster, and Dhruva Kothari. 2010. "Improving Immunisation Coverage in Rural India: Clustered Randomised Controlled Evaluation of Immunisation Campaigns with and without Incentives." BMJ340-222.

Reports & Other Materials