SMS HPV Vaccine Reminders (SEARCH)

SEARCH: Short Message Service (SMS) Electronic Adolescent Reminders for Completion of HPV Vaccination - Uganda: Pilot

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.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus Vaccination
• Intervention / Treatment: Behavioral: Text message reminder

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 Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa S. Stockwell, MD, MPH; Phone Number: 212-342-5732; Email: mss2112@cumc.columbia.edu
• Study Contact Backup: Name: Ashley Stephens, MD; Phone Number: 212-305-6227; Email: abs2258@cumc.columbia.edu

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere University/Mulago Hospital
• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text message reminders	Behavioral: Text message reminder; Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second)
No Intervention: Usual Care; No reminders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Receipt of Next HPV Vaccine Dose	Timeliness of vaccination (time to event) will be measured.	Up to 6 months from randomization

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Cancer Institute (NCI); Makerere University
• Investigators: Principal Investigator: Melissa S. Stockwell, MD, MPH, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: mHealth; Vaccination; Uganda; Human papillomavirus; SMS; Reminder; Text message
• Other Study ID Numbers: AAAT1572; 1R21CA253604-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No