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

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

Enrolling By Invitation
9 years and older
All
Phase 2

Overview

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.

Eligibility

Inclusion Criteria:

  • This study will include children enrolled in Grade 5 in participating schools (ages 9-12 years old) in KwaZulu Natal, 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.
        Exclusion Criteria:
          -  Children below the age of 9 years old will not be included in the study.

Study details
    HPV

NCT05919901

Brigham and Women's Hospital

18 August 2026

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