Condition category
Not Applicable
Date applied
10/02/2015
Date assigned
17/02/2015
Last edited
09/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many families in low- and middle-income countries do not use preventative health services. One potential reason is that they underestimate the health benefits of such services. We will examine whether giving families information designed to improve household perceptions of the benefits of healthcare increases service uptake. The general principle will be tested using the example of the vaccine for diphtheria, pertussis, and tetanus (DPT) for which there is universally accepted evidence on its health benefits. The study takes place in Uttar Pradesh, India.

Who can participate?
Families with a child aged 0-36 months who has not received the recommended three doses of the DPT vaccine.

What does the study involve?
One group of families will receive information that describes the symptoms of tetanus, the possible health consequences, the benefits of getting their child vaccinated against tetanus in terms of mortality and morbidity gains, wider community benefits associated with herd immunity (spillovers), and where the family can get the child vaccinated at what cost and up until what age. A second group of families will receive similar information except that the benefits of vaccination will be framed in negative terms. A third group of families will receive no information and thus act as a control. At least nine months later the vaccination rates of children will be compared across the three groups.

What are the possible benefits and risks of participating?
By taking part in this study there are no risks of physical injury or harm since the research involves no invasive procedures or examinations. Knowledge generated by the study may benefit the health of children in future.

Where is the study run from?
The study has been set up by the London School of Hygiene and Tropical Medicine (UK), working in collaboration with Sambodhi Research and Communications (India).

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start in April 2015. The final data will be collected in April 2016.

Who is funding the study?
Merck Sharp & Dohme Corp (USA) through MSD for Mothers

Who is the main contact?
Dr Timothy Powell-Jackson
Timothy.Powell-Jackson@lshtm.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Timothy Powell-Jackson

ORCID ID

http://orcid.org/0000-0002-6082-3805

Contact details

15-17 Tavistock Place
London
WC1H 9SH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Information and the demand for preventative healthcare: a randomised controlled trial of improving household perceptions on the efficacy of DPT immunisation in Uttar Pradesh, India

Acronym

Study hypothesis

1. Providing households with accurate information on the health benefits of the DPT vaccine will increase uptake of the vaccine.
2. Framing the information as a loss (incurred by not vaccinating the child) will increase uptake of the DPT vaccine more than when the information is framed as a gain (incurred by vaccinating the child).
3. The effect of information is greater amongst those who initially have lower perceptions of the efficacy of DPT vaccine.

Ethics approval

1. The Intervention Research Ethics Committee of the London School of Hygiene and Tropical Medicine in London, 16/12/2014, ref: 8778
2. The institutional review board of the Public HealthCare Society in New Delhi, 18/08/2014
3. The Intervention Research Ethics Committee of the London School of Hygiene and Tropical Medicine in London, amendment 13/11/2017, ref: 8778-1
4. The institutional review board of the Public HealthCare Society in New Delhi, amendment 24/09/2017

Study design

Randomised controlled trial design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet.

Condition

The role of information in influencing household decisions to get their child vaccinated against tetanus

Intervention

Families will be individually randomised into three study arms. Mothers in the first treatment group will be given information on tetanus and benefits of vaccination framed in positive terms. The information script will describe the symptoms of tetanus, possible health consequences, the individual benefit of the combination vaccine in terms of mortality and morbidity gains, wider community benefits associated with herd immunity, and where the family can get the child vaccinated at what cost and up until what age. A second treatment group will provide essentially the same information on efficacy but framed in negative terms. The third arm acts as a control group with no information given to the mother.

Added 08/03/2018:
The trialists are doing a longer term follow-up study of the same study participants. A household survey will be administered at 30 months follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Proportion of study children with three doses of DPT vaccine at endline as verified by the vaccination card or reported by the mother

Added 08/03/2018:
1. Proportion of (index) children with three doses of DPT vaccine at 30 months follow-up as verified by vaccination card or reported by the mother
2. Proportion of other children in the household under five years with three doses of DPT vaccine at 30 months follow-up as verified by vaccination card or reported by the mother

Secondary outcome measures

1. The proportion of children fully vaccinated (against tuberculosis, diphtheria, pertussis, tetanus, polio and measles)
2. An index of the mother’s knowledge of tetanus symptoms
3. An index of the mother’s perception of the efficacy of tetanus vaccination

Added 08/03/2018:
1. Proportion of children fully vaccinated at 30 months follow-up (against tuberculosis, diphtheria, pertussis, tetanus, and measles)
2. Proportion of other children in the household under five years fully vaccinated at 30 months follow-up (against tuberculosis, diphtheria, pertussis, tetanus, and measles)
3. Proportion of children vaccinated with measles vaccine at 30 months follow-up
4. Proportion of other children in the household under five years vaccinated with measles vaccine at 30 months follow-up
5. Proportion of children with suspected diarrhoea in the last four weeks at 30 months follow-up
6. Proportion of children with suspected pneumonia in the last four weeks at 30 months follow-up
7. Proportion of children with suspected diarrhoea in the last four weeks and correctly treated at 30 months follow-up
8. Proportion of children with suspected pneumonia in the last four weeks and correctly treated at 30 months follow-up
9. Mother’s knowledge of any symptom of tetanus at 30 months follow-up
10. Mother’s knowledge of any cause of tetanus at 30 months follow-up
11. Mother’s knowledge of any tetanus prevention method at 30 months follow-up
12. Mother’s perception of the efficacy of tetanus vaccination at 30 months follow-up

Overall trial start date

01/10/2014

Overall trial end date

15/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Mother with a child aged 0-36 months living in the same household
2. Child has not received three doses of DPT vaccine
3. Mother gives consent to participate in the study
4. Mother intends to remain in the study area for the six months

Participant type

Healthy volunteer

Age group

Adult

Gender

Female

Target number of participants

900

Participant exclusion criteria

1. Child of mother is not aged 0-36 months
2. Child of mother is not living in the same household
3. Child has received three doses of DPT vaccine
4. Mother does not give consent to participate in the study
5. Mother due to emigrate from the study area in the six months

Recruitment start date

10/07/2015

Recruitment end date

01/08/2015

Locations

Countries of recruitment

India

Trial participating centre

Sambodhi Research and Communications Limited
O-2, 2nd Floor Lajpat Nagar-II
New Delhi
110024
India

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

Research organisation

Website

http://www.lshtm.ac.uk/

Funders

Funder type

Industry

Funder name

Merck Sharp & Dohme Corp (USA) through MSD for Mothers

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal around one year after the trial end date

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in the LSHTM repository (DataCompass). The data used in the analysis (not the raw complete dataset) are available off the PLOS Med website alongside the paper.

Intention to publish date

15/05/2019

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29509769

Publication citations

Additional files

Editorial Notes

09/03/2018: The overall trial end date was changed from 02/11/2015 to 15/05/2018. 08/03/2018: Details of longer term follow-up study added to ethics approval, interventions and outcome measures fields. Publication reference added.