SMS HPV Vaccine Reminders

NCT ID: NCT05151367

Last Updated: 2024-07-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-23

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Human Papillomavirus Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Text message reminders

Text message reminders

Group Type EXPERIMENTAL

Text message reminder

Intervention Type BEHAVIORAL

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

Usual Care

No reminders

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text message reminder

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Makerere University

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Melissa Stockwell

Associate Professor of Pediatrics and Population and Family Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa S. Stockwell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status

Makerere University/Mulago Hospital

Kampala, , Uganda

Site Status

Countries

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United States Uganda

References

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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.

Reference Type DERIVED
PMID: 40324213 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1R21CA253604-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT1572

Identifier Type: -

Identifier Source: org_study_id

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