SMS HPV Vaccine Reminders

Not Applicable

Completed

• Conditions: Human Papillomavirus Vaccination
• Interventions: Behavioral: Text message reminder

• Registration Number: NCT05151367
• Lead Sponsor: Columbia University

Brief Summary

This study 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, also in Kampala. While text messages can be used in populations with low literacy, families can opt to receive automated phone call reminders instead. The investigators will pilot assess the impact of vaccine reminders on human papillomavirus (HPV) vaccination. Caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). As this is a feasibility trial, the investigators expect to measure effect size but not necessarily achieve statistical significance.

Detailed Description

Cervical cancer is the leading female cancer in Uganda. Many women are diagnosed with late-stage disease, and 80% of women die within 5 years of diagnosis, making primary prevention critical. HPV is the principal cause of cervical cancer, making vaccination the single most important primary preventive measure. The national HPV vaccination program in Uganda began in November 2015 and focuses solely on preteen/adolescent girls. Two strategies have been adopted for the multi-dose series: 1) school-based and 2) community-based. However, in Kampala, only 29% of girls receive both needed doses. Reasons for undervaccination include school absenteeism on special vaccination days for those receiving vaccination as part of a school program, failing to remember to come to a health facility for a needed dose for those being vaccinated in the community, and lack of knowledge regarding HPV and the vaccines including vaccine misperceptions. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not yet been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs). According to the World Bank, currently 89.9% of urban households in Uganda have a cell phone.

Study Timeline

• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2021-11-26
• Study First Posted: 2021-12-09
• Study Start: 2022-02-23
• Primary Completion: 2022-10-30
• Study Completion: 2022-12-31
• Results First Submitted: 2024-02-05
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-03
• Last Update Submitted: 2024-07-03
• Results First Posted: 2024-07-08
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

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 pretesting activities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text message reminders	Text message reminder	Text message reminders

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Received the Next HPV Vaccine Dose	Up to 6 months from randomization	Timeliness of vaccination will be measured by the number of participants who received the next HPV vaccine dose.

Trial Locations

Locations (2)

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

Makerere University/Mulago Hospital; 🇺🇬 Kampala, Uganda