| 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
|
|
|
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
|
|
|
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). |