Study on the effect of the 'talking textile' baby-wrap cloth as communication strategy for childhood vaccination coverage in Niger, West Africa
| ISRCTN | ISRCTN11593716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11593716 |
| Secondary identifying numbers | KeioSFC_263_2019 |
- Submission date
- 11/07/2020
- Registration date
- 30/07/2020
- Last edited
- 19/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
The wax print is a centuries-old style of printed cotton fabric that is used throughout Africa for clothing and other practical items like the baby-carrying cloth or baby-wrap. It is a cultural norm in West Africa and is sometimes used to promote health campaigns. With members from Japan, Niger, and the United States, the baby-wrap team has developed a health literacy project that deploys a factory printed baby-wrap as a 'talking textile' for childhood vaccination information to new mothers. The design of this cloth print was created in collaboration with artists and artisans in Niger. The final prototype of the symbolic calendar was determined through a series of focus groups with mothers organized by the team and local partners. The study aims to evaluate the effect of this baby-wrap as a culturally-relevant communication strategy to increase childhood vaccination uptake and coverage.
Who can participate?
Mothers who have brought a newborn baby to the health center for the baby’s first vaccination visit (BCG vaccination).
What does the study involve?
Mothers who use a health center allocated to the intervention group will receive a free vaccination calendar baby-wrap with a verbal explanation of the design delivered by a trained healthcare agent at the time of routine vaccination services.
Mothers who use a health center allocated to the control group will receive a free, plain length of cloth as a “placebo” baby-wrap that includes neither a visual design nor additional verbal explanation of the vaccination calendar at the time of routine services.
What are the possible benefits and risks of participating?
Benefits for the intervention group mothers would be that through the baby wrap the mother would understand the complex vaccination calendar or at least the time between the appointments and the number of times she must bring her child for vaccination. Risks for the control group mothers would be that they would not acquire knowledge about the vaccination calendar and their babies might not be vaccinated for certain vaccines.
Where is the study run from?
Ministry of Public Health Niamey (Niger)
When is the study starting and how long is it expected to run for?
September 2019 to September 2021
Who is funding the study?
1. Bill & Melinda Gates Foundation (USA)
2. ZTwist Design LLC (USA)
Who is the main contact?
Ms. Mika Kondo Kunieda
mika.kunieda@gmail.com
Contact information
Scientific
Keio University Faculty of Policy Management 5322 Endo
Fujisawa
252-0882
Japan
 ORCID ID |
0000-0002-3412-9860 |
|---|---|
| Phone | +81-466-49-3500 |
| mika.kunieda@gmail.com |
Study information
| Study design | Interventional stratified randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Promoting awareness and timely completion of childhood immunization with the Vaccination Calendar Baby-Wrap for caregivers in Niger |
| Study objectives | The free provision of the baby-wrap with a culturally-relevant design will increase vaccination coverage rates among children and promote maternal knowledge of the recommended vaccination calendar. |
| Ethics approval(s) | 1. Approved 18/11/2019, Niger Ethics Review (Comité National d’Éthique pour la Recherche en Santé CNERS, s/c République du Niger Ministère de la Santé Publique Direction des Etudes et de la Programmation BP 623 Niamey, Niger; no telephone number provided; no email provided), ref: 44/2019/CNERS 2. Approved 02/12/2019, Keio University SFC Ethics Committee for Experimentation and Examination (c/o Keio University Shonan Fujisawa Campus, 5322 Endo Fujisawa, Kanagawa, Japan; no telephone number provided; somu@sfc.keio.ac.jp), ref: approval 263 |
| Health condition(s) or problem(s) studied | Vaccination coverage (for BCG, Pentavalent 1, Pentavalent 3 and measles vaccines) |
| Intervention | This intervention study will be conducted in two phases: Phase One Collect and analyze updated administrative data from the EPI and vaccination coverage data in order to pair health centers in Niamey and allocate them to the intervention and control groups for the randomized control trial (RCT). Health center selection methodology is described in Annex 1. Healthcare personnel at both the intervention and control health centers will receive training on interpersonal communication by local partners in the public health sector. Healthcare personnel at the intervention clinics will be trained to deliver an explanation of the vaccination calendar baby-wrap design to mothers. Phase Two A survey of mothers who bring their newborn infants to the first vaccination appointment at either an intervention or control health center will acquire basic socio-demographic information and assess baseline understanding of vaccination appointments and vaccine-seeking behaviors. The study includes an explanation of the survey and expectations from participants. Mothers interested in participating will give their informed consent through a signature or a thumbprint. Mothers who use a health center allocated to the intervention group will receive a free vaccination calendar baby-wrap with a verbal explanation of the design delivered by a trained healthcare agent at the time of routine vaccination services. Mothers who use a health center allocated to the control group will receive a free, plain length of cloth as a 'placebo' baby-wrap that includes neither a visual design nor additional verbal explanation of the vaccination calendar at the time of routine services. All mothers with infants receiving the first vaccination at both control and intervention health centers will receive the free baby-wraps during a time-limited distribution period to avoid perceptions of unfairness or adverse negative effects associated with perceptions of unfairness. The DRSP Niamey will be responsible for the distribution of both the placebo and vaccination calendar baby-wraps according to the terms set out in this protocol. The surveyed mothers and their infants from both the intervention and control clinics will be monitored for ten months to determine if they have completed the first five visits of the vaccination series, specifically whether they have received BCG at their first visit, Penta 1 at their second visit, Penta 3 at their fourth visit, and measles vaccine at their fifth visit. The Baseline Survey will be administered at the first visit of the mother and child. The Post-Intervention Survey on motivation, ability, and prompts to vaccinate will be administered at the fourth visit when the child is 3 months old. The Post-Intervention Survey will be administered a second time at the fifth visit when the mother comes in for measles vaccine for her 9-month-old child, in order to assess any changes in vaccination knowledge and behavior from the first and second surveys. To address potential perceptions of unfairness or spillover effect between mothers who received the vaccination calendar baby-wrap and those mothers who received the placebo baby-wrap, the selected intervention clinics and the control clinics will be geographically distant so that information will travel slowly, if at all. Mothers will only qualify to receive a baby-wrap if their child is receiving BCG during the fixed distribution period and will not receive more than one baby-wrap. The mothers in the control group will be administered the same surveys as mothers in the intervention group. If mothers in either the control or intervention group do not come back for subsequent vaccination appointments, they will be contacted a full month after the missed vaccination date for a phone interview using the same questionnaire used for women who received the survey in person. The goal of the phone interview will be to determine if women who dropped out experienced increased barriers that prevented them from returning for vaccination. It is expected that the phone interview will prompt mothers to re-engage with the health system, therefore, data from any subsequent vaccinations will be tracked separately from participants who were interviewed in person at the health clinics. Follow-up of participants will be for 10 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Vaccination coverage of children measured using patient records at 9 months |
| Secondary outcome measures | Maternal knowledge of the recommended vaccination calendar at baseline and follow up (9 months) using the Fogg behavioral model questionnaire on motivation |
| Overall study start date | 01/09/2019 |
| Completion date | 30/09/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1,000 |
| Total final enrolment | 1697 |
| Key inclusion criteria | 1. Mothers with newborn infants residing in Niamey, Niger 2. The mother has brought a newborn baby to the health center for the baby’s first vaccination visit (BCG vaccination) 3. The parents/mother have/has given their/her consent by signature or thumbprint, to being interviewed three times during the study period, after being informed of the survey |
| Key exclusion criteria | 1. Those persons who do not consent to be interviewed 2. Those mothers and newborns who do not intend to stay in Niamey during the study period (approximately ten months) |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 31/10/2020 |
Locations
Countries of recruitment
- Niger
Study participating centre
-
Niger
Sponsor information
Other
#303 151 Tremont Street
Suite 110
Boston
02111
United States of America
| Phone | +1 7817899909 |
|---|---|
| julia@ztwist.design | |
| Website | https://www.ztwist.design/ |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 19/10/2022 | No | No |
Additional files
Editorial Notes
19/10/2022: Protocol uploaded (not peer reviewed). The intention to publish date was changed from 01/06/2022 to 31/12/2022.
03/06/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/06/2021 to 30/09/2021 and the plain English summary has been updated to reflect this change.
2. The total final enrolment number has been added.
04/09/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 10/08/2020 to 01/10/2020.
2. The recruitment end date was changed from 30/09/2020 to 31/10/2020.
24/07/2020: Trial’s existence confirmed by Ministere de la sante publique, Republique du Niger.
