HPV Vaccine Reminders - SEARCH II Study

Human Papillomavirus Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161831
• Other study ID #: AAAT1572_2
• Secondary ID: R33CA253604
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2024
• Source: Columbia University
• Contact: Melissa S Stockwell, MD MPH
• Phone: 212-342-5732
• Email: mss2112[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: July 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus Vaccination

Intervention

Behavioral:
• Text Message/automated phone reminder
Receipt of text message or automated phone reminders notifying when the next HPV vaccine dose is due (either first or second)

Locations

Country	Name	City	State
Uganda	Makerere University/Mulago Hospital	Kampala
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Makerere University, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Receipt of First HPV Vaccine Dose	Timeliness of vaccination (time to event) will be measured	12 months
Primary	Time to Receipt of Second HPV Vaccine Dose	Timeliness of vaccination (time to event) will be measured	12 months