Clinical trial NCT04177485: Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda
Official title: Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda-a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diphtheria
Tetanus
Pertussis
Polio
Measles
Hepatitis B
Haemophilus Influenzae Type b Infection
Keywords: SMS reminder
vaccination
immunization
vaccination drop-out
vaccination timeliness
text reminder
mHealth
cell phone
mobile phone
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: African Field Epidemiology Network
name: Ministry of Health, Uganda
name: Health Information Systems Programme-Uganda
name: Bill and Melinda Gates Foundation
First posted: 2019-11-26
Enrollment: 1962
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Faced with high rates of immunization drop-out, Uganda's immunization program requires innovative approaches to address this weakness. Building upon Uganda's growing mHealth infrastructure to pilot a scalable short message service (SMS) system to remind caregivers of their children's upcoming vaccination visits, it was hypothesized that the SMS intervention will increase immunization coverage in a cost-effective and affordable manner that would make it scalable. The study design was an investigator-blinded, multi-center, parallel groups randomized controlled trial with randomization occurring at the caregiver level in select health facilities of Arua District in Uganda. Enrollment took place at the time of Pentavalent 1 vaccination, and both arms included standard of care provided by the health worker. However, in the intervention arm, caregivers also received SMS text messages reminding them to return for their children's second and third doses of Pentavalent vaccine (four and eight weeks after the first dose of Pentavalent vaccine) and measles-containing vaccine (9 months of age). The primary outcome of interest is vaccination coverage at 12 months of age among children enrolled in the study and will be measured by comparing Penta3 and MCV coverage between arms. The study will also examine the SMS impact on timeliness of vaccine receipt, as it is hypothesized that those children receiving the SMS intervention will be more likely to have timely vaccination than those in the control group. The study will also assess caregiver acceptability and cost-effectiveness of the SMS intervention. In addition to assessing its impact on strengthening the immunization program, this intervention has implications for strengthening other programs of the health system through similar health messaging directed toward caregivers.


Eligibility criteria: Inclusion Criteria:

* Is a caregiver of a child between the ages of 6 weeks and 6 months of age and presents at one of the study sites for child's Penta1 vaccination
* Access to a personal or household cell phone that can receive text messages
* Lives in Arua district

Exclusion Criteria:

* Does not have access to the cell phone number at time of registration
* Does not agree or is unable to consent to participate in the study
* Does not anticipate being the caregiver through the child's first birthday
* Plans to move out of Arua district in the upcoming year
* Prior enrollment of the caregiver with a different child

Primary outcomes:
measure: Number of participants who received MCV by 12 months of age as assessed by data abstraction of home-based records at endline survey.
timeFrame: through study completion, an average of 12 months in the study
Secondary outcomes:
measure: Number of participants who received all eligible vaccines (Penta2, PCV2, Polio2, Penta3, PCV3, Polio3, MCV) as assessed by data abstraction of home-based records and caregiver recall at endline survey.
timeFrame: through study completion, an average of 12 months in the study
measure: Number of participants who received Penta3 within 12 weeks of Penta1 as assessed by data abstraction of home-based records at endline survey.
timeFrame: through study completion, an average of 12 months in the study
measure: Number of participants who received MCV by 10 months of age as assessed by data abstraction of home-based records at endline survey.
timeFrame: through study completion, an average of 12 months in the study
measure: Number of participants who would be interested in receiving SMS immunization reminders for their next child, as assessed with a yes/no question at the endline survey.
timeFrame: through study completion, an average of 12 months in the study
measure: Cost per additional child that is up-to-date with vaccination
timeFrame: through study completion, an average of 12 months in the study
measure: Number of participants who received Penta3 by 12 months of age as assessed by data abstraction of home-based records at endline survey.
timeFrame: through study completion, an average of 12 months in the study
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Daniel C Ehlman, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehlman DC, Magoola J, Tanifum P, Wallace AS, Behumbiize P, Mayanja R, Luzze H, Yukich J, Daniels D, Mugenyi K, Baryarama F, Ayebazibwe N, Conklin L. Evaluating a Mobile Phone-Delivered Text Message Reminder Intervention to Reduce Infant Vaccination Dropout in Arua, Uganda: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Feb 24;10(2):e17262. doi: 10.2196/17262.