Skip to main content
OpenTrials
Completed

NCT Number: NCT04177485

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diphtheria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Central Nervous System Diseases Central Nervous System Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Enterovirus Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type B Infection Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Measles Mononegavirales Infections Morbillivirus Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Paramyxoviridae Infections Pasteurellaceae Infections Pertussis Picornaviridae Infections Polio Poliomyelitis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Spinal Cord Diseases Tetanus Virus Diseases Whooping Cough

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: through study completion, an average of 12 months in the study

Secondary outcomes

  1. 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.

    Time frame: through study completion, an average of 12 months in the study

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

    Time frame: through study completion, an average of 12 months in the study

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

    Time frame: through study completion, an average of 12 months in the study

  4. 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.

    Time frame: through study completion, an average of 12 months in the study

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

    Time frame: through study completion, an average of 12 months in the study

    From the MOH perspective, what is the cost-effectiveness of the SMS reminder system per additional child that is up-to-date with vaccination?

  6. Number of participants who received Penta3 by 12 months of age as assessed by data abstraction of home-based records at endline survey.

    Time frame: through study completion, an average of 12 months in the study

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • African Field Epidemiology Network
  • Bill and Melinda Gates Foundation
  • Health Information Systems Programme-Uganda
  • Ministry of Health, Uganda

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 26, 2019
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.