NCT05151367

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 8, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

8 months

First QC Date

November 26, 2021

Results QC Date

February 5, 2024

Last Update Submit

July 3, 2024

Conditions

Keywords

Human papillomavirusVaccinationText messageSMSmHealthReminderUganda

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Received the Next HPV Vaccine Dose

    Timeliness of vaccination will be measured by the number of participants who received the next HPV vaccine dose.

    Up to 6 months from randomization

Study Arms (2)

Text message reminders

EXPERIMENTAL

Text message reminders

Behavioral: Text message reminder

Usual Care

NO INTERVENTION

No reminders

Interventions

Receipt of text messages notifying when the next HPV vaccine dose is due (either first or second)

Text message reminders

Eligibility Criteria

Age10 Years - 14 Years
Sexfemale
Healthy VolunteersYes
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 pretesting activities

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

Related Publications (1)

  • Kitaka SB, Rujumba J, Zalwango SK, Pfeffer B, Kizza L, Nattimba JP, Stephens AB, Nabukeera-Barungi N, Wynn CS, Babirye JN, Mukisa J, Mupere E, Stockwell MS. SEARCH Study: Text Messages and Automated Phone Reminders for HPV Vaccination in Uganda: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 May 5;13:e63527. doi: 10.2196/63527.

Results Point of Contact

Title
Melissa Stockwell
Organization
Columbia University

Study Officials

  • Melissa S. Stockwell, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

November 26, 2021

First Posted

December 9, 2021

Study Start

February 23, 2022

Primary Completion

October 30, 2022

Study Completion

December 31, 2022

Last Updated

July 8, 2024

Results First Posted

July 8, 2024

Record last verified: 2024-07

Locations