Evaluating a Caregiver SMS Reminder Intervention to Reduce Immunization Drop-out in Arua, Uganda

NCT04177485 | Completed

• 1 other identifier: 6721
• Study Type: interventional
• Target: 1,962
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of participants who received MCV by 12 months of age as assessed by data abstraction of home-based records at endline survey.

  through study completion, an average of 12 months in the study

Secondary Outcomes (6)

• 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.

  through study completion, an average of 12 months in the study

• Number of participants who received Penta3 within 12 weeks of Penta1 as assessed by data abstraction of home-based records at endline survey.

  through study completion, an average of 12 months in the study

• Number of participants who received MCV by 10 months of age as assessed by data abstraction of home-based records at endline survey.

  through study completion, an average of 12 months in the study

• 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.

  through study completion, an average of 12 months in the study

• Cost per additional child that is up-to-date with vaccination

  through study completion, an average of 12 months in the study

Study Arms (2)

Standard of Care + SMS text reminders

EXPERIMENTAL

Standard of Care + SMS text reminders to be sent to caregivers for each of their subsequent vaccination visits, as per the EPI schedule (Penta2/OPV2/PCV2, Penta3/OPV3/PCV3, and MCV)

Behavioral: SMS text reminders

Standard of Care

NO INTERVENTION

\*Standard of care was defined as the health worker providing vaccination cards (home based records) to caregivers, as available, and providing verbal instruction of when to return for the next visit.

Interventions

SMS text reminders BEHAVIORAL

SMS reminders (in English and the local language) for the 2nd dose of Pentavalent vaccine were sent 28, 30 and 32 days after the 1st dose. SMS reminders for the 3rd dose of Pentavalent vaccine were sent 61, 66, and 68 days after the 1st dose. SMS reminders for the measles-containing vaccine were sent 274, 279, and 281 days after the child's date of birth.

Standard of Care + SMS text reminders

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• African Field Epidemiology Network: collaborator
• Ministry of Health, Uganda: collaborator
• Health Information Systems Programme-Uganda: collaborator
• Bill and Melinda Gates Foundation: collaborator

Related Publications (1)

• 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.

  PMID: 33625372 DERIVED

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough; Poliomyelitis; Measles; Hepatitis B; Haemophilus Infections

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Pasteurellaceae Infections

Study Officials

• Daniel C Ehlman, MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 26, 2019
• Study Start: February 1, 2016
• Primary Completion: December 4, 2017
• Study Completion: December 4, 2017
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share