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Clinical Trials/NCT06161831
NCT06161831
Active, Not Recruiting
N/A

SEARCH II: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Randomized Controlled Trial

Columbia University2 sites in 2 countries396 target enrollmentApril 22, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Human Papillomavirus Vaccination
Sponsor
Columbia University
Enrollment
396
Locations
2
Primary Endpoint
Time to Receipt of Second HPV Vaccine Dose
Status
Active, Not Recruiting
Last Updated
7 months ago

Overview

Brief Summary

This RCT will take place at health centres and their affiliated schools and community immunization centers overseen by the Kampala Capital City Authority (KCCA) as well as at the Makerere/Mulago/Columbia Adolescent Health Clinic in Kampala. The investigators will assess the impact of vaccine text message and automated phone reminders on human papillomavirus (HPV) vaccination initiation and completion.

Detailed Description

Cervical cancer is the leading female cancer in Uganda. HPV is the principal cause of cervical cancer. The national HPV vaccination program in Uganda includes preteen/ adolescent girls. Vaccinations are provided within schools or through community health centers. However, in Kampala, HPV vaccination especially series completion is low. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs) in a full RCT. In this study, RCT caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). Intervention families will receive text message or automated phone reminders based on family preference.

Registry
clinicaltrials.gov
Start Date
April 22, 2024
End Date
July 31, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Melissa Stockwell

Professor of Pediatrics and Population and Family Health

Columbia University

Eligibility Criteria

Inclusion Criteria

  • Be a parenting adult of an adolescent girl aged 10-14 years
  • Reside in Kampala and/or the surrounding districts
  • Speak English or Luganda
  • Have a cell phone with text messaging capability
  • Must have ability to consent

Exclusion Criteria

  • Parenting adult speaks other language than English or Luganda only
  • Parenting adult already enrolled in the study for another child
  • Participation in previous HPV vaccine reminder study

Outcomes

Primary Outcomes

Time to Receipt of Second HPV Vaccine Dose

Time Frame: 12 months

Timeliness of vaccination (time to event) will be measured

Time to Receipt of First HPV Vaccine Dose

Time Frame: 12 months

Timeliness of vaccination (time to event) will be measured

Study Sites (2)

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