HPV Vaccine Reminders - SEARCH II Study

Not Applicable

Recruiting

• Conditions: Human Papillomavirus Vaccination
• Interventions: Behavioral: Text Message/automated phone reminder

• Registration Number: NCT06161831
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-08
• Study Start: 2024-04-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2026-05-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text message/automated phone reminders	Text Message/automated phone reminder	Text message or automated phone reminders

Primary Outcome Measures

Name	Time	Method
Time to Receipt of Second HPV Vaccine Dose	12 months	Timeliness of vaccination (time to event) will be measured
Time to Receipt of First HPV Vaccine Dose	12 months	Timeliness of vaccination (time to event) will be measured

Trial Locations

Locations (2)

Makerere University/Mulago Hospital; 🇺🇬 Kampala, Uganda

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States