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

NCT05919901 | Suspended

• 1 other identifier: 2023p001246
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HPV

Outcome Measures

Primary Outcomes (2)

• Uptake of HPV vaccine

  Successful uptake of 1 dose of HPV vaccine

  within Six Months

• Feasibility of delivering the intervention

  Feasibility will be assessed using the Feasibility of Intervention Measure.

  Six Months

Secondary Outcomes (1)

• Preliminary Effectiveness of the HPV intervention

  Six Months

Study Arms (2)

HPV Intervention

EXPERIMENTAL

Other: HPV Vaccine Communication Strategy

Active Control

ACTIVE COMPARATOR

Other: HPV Vaccine Communication Strategy

Interventions

HPV Vaccine Communication Strategy OTHER

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

Active Control; HPV Intervention

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children below the age of 9 years old will not be included in the study.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Witwatersrand Health Consortium

Johannesburg, Gautang, South Africa

Location

Related Publications (3)

• Centers for Disease Control and Prevention. Genital HPV Infection - Basic Fact Sheet. 2022. https://www.cdc.gov/std/hpv/stdfact-hpv.htm

  BACKGROUND

• Szymonowicz KA, Chen J. Biological and clinical aspects of HPV-related cancers. Cancer Biol Med. 2020 Nov 15;17(4):864-878. doi: 10.20892/j.issn.2095-3941.2020.0370. Epub 2020 Dec 15.

  PMID: 33299640 BACKGROUND

• South Africa: Human Papillomavirus and Related Cancers, Fact Sheet 2021. Institut Català d'Oncologia; 2021. https://hpvcentre.net/statistics/reports/ZAF_FS.pdf

  BACKGROUND

Related Links

• South Africa: Human Papillomavirus and Related Cancers, Fact Sheet 2021 by Institut Català d'Oncologia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 26, 2023
• Study Start: July 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)