NCT02662595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,050

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

1.8 years

First QC Date

January 20, 2016

Last Update Submit

January 22, 2016

Conditions

Keywords

mHealthmobile phonesmeasles vaccination

Outcome Measures

Primary Outcomes (1)

  • MV Coverage at 12 months of age

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

    12 months of age

Secondary Outcomes (2)

  • Timeliness

    At 12 months

  • Average number of visits

    At 12 months

Study Arms (3)

Control

NO INTERVENTION

Text message

ACTIVE COMPARATOR

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

Other: SMS reminder message

Text message and voice call

ACTIVE COMPARATOR

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

Other: Voice call + SMS message

Interventions

Text message
Text message and voice call

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Varela Health Center

Varela, Cacheu Region, Guinea-Bissau

Location

Paunca Health Center

Paunca, Gabú, Guinea-Bissau

Location

Catio Health Center

Catío, Tombali, Guinea-Bissau

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Measles

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Central Study Contacts

Emil Rossing, MA

CONTACT

Amabélia Rodrigues, Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 25, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations