HPV Vaccine Reminders - SEARCH II Study

NCT ID: NCT06161831

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-22

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Cervical cancer is the leading female cancer in Uganda. HPV is the principal cause of cervical cancer. The national HPV vaccination program in Uganda includes preteen/ adolescent girls. Vaccinations are provided within schools or through community health centers. However, in Kampala, HPV vaccination especially series completion is low. While research regarding the use of text message vaccine reminders is strong in the U.S., their use has not been demonstrated in a preteen/adolescent population in Sub-Saharan Africa and other low and middle income countries (LMICs) in a full RCT. In this study, RCT caregivers of preteens/adolescents will be randomized and stratified by site, language and HPV vaccine dose needed (initiation vs. completion). Intervention families will receive text message or automated phone reminders based on family preference.

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

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Text message/automated phone reminders

Text message or automated phone reminders

Group Type EXPERIMENTAL

Text Message/automated phone reminder

Intervention Type BEHAVIORAL

Receipt of text message or automated phone reminders 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/automated phone reminder

Receipt of text message or automated phone reminders 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 previous HPV vaccine reminder study
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

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

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

Other Identifiers

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R33CA253604

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAT1572_2

Identifier Type: -

Identifier Source: org_study_id

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