NCT06161831

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Apr 2024Jul 2026

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

November 30, 2023

Last Update Submit

September 5, 2025

Conditions

Human Papillomavirus Vaccination

Keywords

Human papillomavirusVaccinationText messageSMSmHealthUganda

Outcome Measures

Primary Outcomes (2)

  • Time to Receipt of First HPV Vaccine Dose

    Timeliness of vaccination (time to event) will be measured

    12 months

  • Time to Receipt of Second HPV Vaccine Dose

    Timeliness of vaccination (time to event) will be measured

    12 months

Study Arms (2)

Text message/automated phone reminders

EXPERIMENTAL

Text message or automated phone reminders

Behavioral: Text Message/automated phone reminder

Usual Care

NO INTERVENTION

No reminders

Interventions

Text Message/automated phone reminderBEHAVIORAL

Receipt of text message or automated phone reminders notifying when the next HPV vaccine dose is due (either first or second)

Text message/automated phone reminders

Eligibility Criteria

Age10 Years - 14 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Makerere University/Mulago Hospital

Kampala, Uganda

Location

Study Officials

  • Melissa S Stockwell, MD MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics and Population and Family Health

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

April 22, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09

Locations

UG(1)US(1)