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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02904642
Other study ID # KEMRI SERU-3311
Secondary ID
Status Completed
Phase N/A
First received September 8, 2016
Last updated February 27, 2018
Start date December 6, 2016
Est. completion date April 4, 2017

Study information

Verified date February 2018
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall objective is to test the impact of short message service (SMS) reminders, with or without unconditionally provided mobile-money incentives, can improve measles vaccination coverage in rural western Kenyan infants.


Description:

Primary Objective The primary objective is to determine if text message reminders, with or without unconditionally provided incentives, can increase the proportion of children who receive measles vaccination by 15% at age ten months as compared to control arm children.

Secondary Objectives

1. To conduct a secondary analysis of the primary outcome using survival analysis and time-to-immunization curves.

2. To determine if there is a differential effect on measles vaccine coverage based on mobile phone ownership and distance to the clinic.

3. To examine the effect of the interventions on measles coverage measured at twelve months of age.

4. To examine the completeness and costs of identifying children through a CHW approach versus the standard HDSS approach.

5. To evaluate the effect of the interventions on coverage of second dose of measles vaccine at 24 months. This secondary objective is contingent on receiving additional funding.


Recruitment information / eligibility

Status Completed
Enrollment 537
Est. completion date April 4, 2017
Est. primary completion date April 4, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Caregiver of infant aged 6-8 months at time of enrollment

- Self-reported resident of one of the study villages; where the definition of a resident is defined by caregiver

- Willing to sign informed consent for the study

Exclusion Criteria:

- Child of enrolled caregiver has already received one dose of measles vaccine, not including any supplemental measles vaccines

- Caregiver plans to move away in the next 6 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SMS reminder
Caregivers will receive two text message reminders for their child's measles immunization scheduled for 9 months of age
Unconditional Incentive
A mobile-money incentive in the amount of 150 Kenyan Shillings will be transferred to the enrolled caregiver's mobile phone when the child reaches nine months of age

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Bill and Melinda Gates Foundation, Kenya Medical Research Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Measles vaccination coverage Proportion of children receiving measles vaccination by 10 months of age by study arm 10 months
Secondary Time to measles vaccination (in days) using Kaplan-Meier Survival Analysis As a secondary analysis of the primary outcome, time-to-measles immunization curves will be constructed using the Kaplan-Meier method and study arms will be compared using the Cox model. The 25th, 50th, and 75th percentiles for time to immunization and the number of days delayed, in relation to the measles due date, will also be reported for each vaccine and by study arm. 12 months
Secondary Proportion of children who receive measles vaccination stratified by demographic variables A priori we will conduct sub group analyses of the primary outcome for mobile phone ownership, birth order of the enrolled caregiver's child, and time to clinic. Additional variables for subgroup analyses will come from a risk factor analysis of not receiving measles vaccination in the control arm 10 months
Secondary Measles vaccination coverage at 12 months Proportion of children who receive measles vaccination by twelve months of age by study arm 12 months
Secondary Vaccination coverage for second dose of measles vaccine at 24 months. This outcome is dependent on receiving more funding 24 months
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