FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/04/008379 [Registered on: 20/04/2017] Trial Registered Retrospectively
Last Modified On: 10/12/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   A randomized controlled trial to study the effects of video education on vaccine coverage 
Scientific Title of Study   Community-led Video Education to Increase Vaccination Coverage in Uttar Pradesh, India: A Cluster-Randomized, Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sudip Mahapatra 
Designation  Regional Monitoring and Evaluation Specialist 
Affiliation  PATH 
Address  15th Floor, Dr. Gopal Das Bhawan, 28 Barakhamba Road, Connaught Place

New Delhi
DELHI
1100601
India 
Phone    
Fax    
Email  smahapatra@path.org  
 
Details of Contact Person
Scientific Query
 
Name  Sudip Mahapatra 
Designation  Regional Monitoring and Evaluation Specialist 
Affiliation  PATH 
Address  15th Floor, Dr. Gopal Das Bhawan, 28 Barakhamba Road, Connaught Place

New Delhi
DELHI
110001
India 
Phone  91-11-64040001  
Fax    
Email  smahapatra@path.org  
 
Details of Contact Person
Public Query
 
Name  Sudip Mahapatra 
Designation  Regional Monitoring and Evaluation Specialist 
Affiliation  PATH 
Address  15th Floor, Dr. Gopal Das Bhawan, 28 Barakhamba Road, Connaught Place

New Delhi
DELHI
110001
India 
Phone  91-11-40640001  
Fax    
Email  smahapatra@path.org  
 
Source of Monetary or Material Support  
3ie: International Initiative for Impact Evaluation 202-203, 2nd Floor, Rectangle One, D-4, Saket District Centre, New Delhi, New Delhi 110017, India  
 
Primary Sponsor  
Name  PATH 
Address  2201 Westlake Avenue, Suite 200 Seattle, WA 98121 USA India 
Type of Sponsor  Other [NGO] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sudip Mahapatra  Airaya and Hathgaon  Airaya and Hathgaon
Fatehpur
UTTAR PRADESH 
91-11-40640001

smahapatra@path.org 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Center for Operations Research and Training  Approved 
PATH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mothers with an infant between 6 and 17 months of age.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control - no intervention  The video intervention will not be administered to the comparator group; they are not restricted from being messages by other health campaign 
Intervention  Video education on health  Health messaging on maternal and child and health shared through video tools and mothers groups 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Mothers with children ages 6-17 months whose primary home is in the intervention village and consent to be interviewed.  
 
ExclusionCriteria 
Details  Women who are younger than 18 or older than 45 will not be included. Women who do not have a child aged 6-17 months or decline to participate will also be excluded.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
% infants ages 6-17 months who are fully immunized  Baseline and endline (18 months) 
 
Secondary Outcome  
Outcome  TimePoints 
% of infants ages 6-17 months who received vaccines on time (6, 10, 14 weeks, and 9 months)  Baseline and endline (18 months) 
% infants ages 6-17 months who completed DTP 1 but not DTP 3
 
baseline and endline (18 months) 
% infants aged 6-17 months who completed OPV1 but not OPV3  Baseline and endline (18 months) 
 
Target Sample Size   Total Sample Size="1296"
Sample Size from India="1296" 
Final Enrollment numbers achieved (Total)= "2486"
Final Enrollment numbers achieved (India)="2486" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/11/2016 
Date of Study Completion (India) 01/11/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/11/2018 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Manuscripts in draft at this time; publication pending submission.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Impact of the intervention was measured by using a cluster randomized control trial. There are two arms: an intevention arm which received the Projecting Health (PH) curriculum, and a control arm which did not receive the intervention. The PH intervention was not part of the research study and was separately funded and implemented. The purpose of the study was to assess the impact of the PH intervention in increasing knowledge and changing immunization practices of the women between ages 18 and 45 exposed to the video messages on select immunization areas. The information collected during the baseline and endline study will be used to inform impact of video messaging as a tool to increase knowledge and change behaviors in key immunization areas. The research was conducted in 72 villages in Uttar Pradesh, India. The study participants are women between 18 and 45 years with a child between 6-17 months, the women’s husbands and mother-inlaws, and frontline healthcare workers residing in the intervention blocks. The participants were asked for their written consent to participate in an interview that lasted about one hour, asking them about their knowledge of key immunization health topics and video exposure. There was no direct benefit to the participants as a result of participating in this study.

Key highlights of the study results include: 

- The study observed an increase in the proportion of children who were fully vaccinated and a     decrease in the proportion of drop-out from the vaccine series, although the change was not statistically significant.

Amongst children living in hard-to-reach areas, the study observed an increase in the proportion of children who were fully vaccinated and decreased drop-out (statistically significant). This is likely because the intervention encouraged ASHA engagement with hard-to-reach households. No other subgroups had statistically significant differences observed.

Study shows that there was a marginal increase the mean maternal knowledge score, a composite of 21 knowledge questions on the survey, in the intervention as compared to control clusters, controlling for time effects (p = 0.660).

 
Close