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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02662595
Other study ID # MIMI-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 20, 2016
Last updated January 22, 2016
Start date March 2016
Est. completion date January 2018

Study information

Verified date January 2016
Source Bandim Health Project
Contact Emil Rossing, MA
Phone +2455772149
Email emro@ssi.dk
Is FDA regulated No
Health authority Guinea-Bissau: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1050
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 3 Months
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Other:
SMS reminder message

Voice call + SMS message


Locations

Country Name City State
Guinea-Bissau Catio Health Center Catío Tombali
Guinea-Bissau Paunca Health Center Paunca Gabú
Guinea-Bissau Varela Health Center Varela Cacheu

Sponsors (1)

Lead Sponsor Collaborator
Bandim Health Project

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Timeliness Difference in timeliness of measles vaccines administered, measured as median age of measles vaccinated children. At 12 months No
Secondary Average number of visits Average number of visits to the health center with the purpose of receiving MV needed before MV is successfully administered. At 12 months No
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