Multi-level School-based Intervention to Improve HPV Vaccine Uptake and Completion in South Africa

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

SUSPENDED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-26

Study Completion Date

2026-06-30

Brief Summary

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Human Papillomavirus (HPV) is the most common sexually transmitted infection globally, and is causally linked to cervical, anogenital, and oropharyngeal cancers. HPV-associated cancers have a disproportionate impact in low-resource settings and nowhere is this evident than in South Africa, which has a uniquely vulnerable population due to the convergence of the largest HIV epidemic globally, with HPV rates of up to 85% in young women under the age of 25. For the clinical trial phase of this study, we intend to evaluate preliminary effects of a communications strategy and key criteria to advance to a full scale hybrid type 2 trial. Our systems-focused approach leverages established partnerships with area schools serving diverse populations who are not always effectively served by traditional healthcare channels.

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Detailed Description

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Conditions

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HPV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will select 10 schools (\~60 parents/children per school) by a stratified random sampling approach. We will randomize schools in a 1:1 ratio to the intervention and control arms. Randomization, based on a computer-generated assignment, will occur after the 10 schools have been selected. Control participants will be eligible to receive the intervention materials at the end of the 1-year follow-up period.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HPV Intervention

Group Type EXPERIMENTAL

HPV Vaccine Communication Strategy

Intervention Type OTHER

The intervention will include health promotions materials and provision of HPV vaccine

Active Control

Group Type ACTIVE_COMPARATOR

HPV Vaccine Communication Strategy

Intervention Type OTHER

The intervention will include health promotions materials and provision of HPV vaccine

Interventions

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HPV Vaccine Communication Strategy

The intervention will include health promotions materials and provision of HPV vaccine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* This study will include children enrolled in Grade 5 in participating schools (ages 9-12 years old) in Gauteng province, South Africa, who have no prior history of HPV immunization. We have selected fifth graders for our target population to follow the current Provincial Guidelines. This is in line with National Cervical Guidelines aimed at reaching young people prior to their sexual debut.

We will also be recruiting parents/caregivers of these children, given their role in decision-making. All parents/caregivers will be at least 18 years old. We will also be including adults who are at least 18 years of age, who are employed at participating schools as teachers or school administrators, and others who are engaged in the planning or implementation of the school-based HPV vaccine program (e.g., representatives from the Department of Health, nurses). We have no upper age limit for this population.