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mHealth to Increase Measles Immunization - a Randomized Controlled Trial in Guinea-Bissau (mimi)

Primary Purpose

Measles

Status
Unknown status
Phase
Not Applicable
Locations
Guinea-Bissau
Study Type
Interventional
Intervention
SMS reminder message
Voice call + SMS message
Sponsored by
Bandim Health Project
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Measles focused on measuring mHealth, mobile phones, measles vaccination

Eligibility Criteria

undefined - 3 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • the mother has access to a cell phone (either her own phone or the phone of a household member)
  • the mother lives in the uptake area of the health center.

Exclusion Criteria:

  • the mother does not have access to a mobile phone.

Sites / Locations

  • Varela Health Center
  • Paunca Health Center
  • Catio Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Text message

Text message and voice call

Arm Description

Subjects in this arm will receive a text message reminder in due time for measles vaccination.

Subjects in this arm will receive a voice call in addition to a text message reminder in due time for measles vaccination.

Outcomes

Primary Outcome Measures

MV Coverage at 12 months of age
Difference in measles vaccination coverage at 12 months of age between the intervention and the control groups.

Secondary Outcome Measures

Timeliness
Difference in timeliness of measles vaccines administered, measured as median age of measles vaccinated children.
Average number of visits
Average number of visits to the health center with the purpose of receiving MV needed before MV is successfully administered.

Full Information

First Posted
January 20, 2016
Last Updated
January 22, 2016
Sponsor
Bandim Health Project
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1. Study Identification

Unique Protocol Identification Number
NCT02662595
Brief Title
mHealth to Increase Measles Immunization - a Randomized Controlled Trial in Guinea-Bissau
Acronym
mimi
Official Title
Mimi - mHealth to Increase Measles Immunization. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bandim Health Project

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The question that this project seeks to answer, is whether mobile phones can be used to increase the measles vaccination coverage and timeliness in Guinea-Bissau. The intervention will be evaluated in terms of direct health outcomes and cost/benefit analysis, generating evidence that could help policy makers making informed decisions about implementing mHealth interventions at a national level. The intervention takes the form of a randomized controlled trial in which text messages (SMS) as well as voice calls are scheduled and delivered to mo thers to remind and encourage them to have their children timely vaccinated against measles. In addition, the messages will include relevant information about opening hours and availability of the measles vaccine at the mothers' local health facilities thus improving coordination. The trial will include three different randomization groups with approx. 350 participants in each group. The first group will receive SMS messages, the second group will receive a voice call in addition to the SMS messages, and the third group is a control group that does not receive any intervention. Study participants will be enrolled following birth at one of three health centers in different rural regions of Guinea-Bissau. Before the measles vaccine is scheduled to be given, at 9 months of age, mothers will receive the intervention message depending on their assigned randomization group. When the measles vaccine is administered, the child will be registered as having received the measles vaccination. A follow-up phone interview will be conducted at 12 months of age for all children participating regardless of randomization group and whether or not they received the measles vaccine. All participating children, who at that time still have not received the measles vaccine, will be offered the vaccine at the expense of the project.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles
Keywords
mHealth, mobile phones, measles vaccination

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Text message
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive a text message reminder in due time for measles vaccination.
Arm Title
Text message and voice call
Arm Type
Active Comparator
Arm Description
Subjects in this arm will receive a voice call in addition to a text message reminder in due time for measles vaccination.
Intervention Type
Other
Intervention Name(s)
SMS reminder message
Intervention Type
Other
Intervention Name(s)
Voice call + SMS message
Primary Outcome Measure Information:
Title
MV Coverage at 12 months of age
Description
Difference in measles vaccination coverage at 12 months of age between the intervention and the control groups.
Time Frame
12 months of age
Secondary Outcome Measure Information:
Title
Timeliness
Description
Difference in timeliness of measles vaccines administered, measured as median age of measles vaccinated children.
Time Frame
At 12 months
Title
Average number of visits
Description
Average number of visits to the health center with the purpose of receiving MV needed before MV is successfully administered.
Time Frame
At 12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: the mother has access to a cell phone (either her own phone or the phone of a household member) the mother lives in the uptake area of the health center. Exclusion Criteria: the mother does not have access to a mobile phone.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emil Rossing, MA
Phone
+2455772149
Email
emro@ssi.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Amabélia Rodrigues, Dr.
Email
a.rodrigues@bandim.org
Facility Information:
Facility Name
Varela Health Center
City
Varela
State/Province
Cacheu
Country
Guinea-Bissau
Facility Name
Paunca Health Center
City
Paunca
State/Province
Gabú
Country
Guinea-Bissau
Facility Name
Catio Health Center
City
Catío
State/Province
Tombali
Country
Guinea-Bissau

12. IPD Sharing Statement

Citations:
PubMed Identifier
32813276
Citation
Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
Results Reference
derived
PubMed Identifier
27466046
Citation
Rossing E, Ravn H, Batista CS, Rodrigues A. MHealth to Improve Measles Immunization in Guinea-Bissau: Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2016 Jul 27;5(3):e158. doi: 10.2196/resprot.5968.
Results Reference
derived

Learn more about this trial

mHealth to Increase Measles Immunization - a Randomized Controlled Trial in Guinea-Bissau

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