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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HPV
• Intervention / Treatment: Other: HPV Vaccine Communication Strategy

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ingrid T Katz, MD, BA, MHS; Phone Number: 617-525-8194; Email: ikatz2@partners.org
• Study Contact Backup: Name: Eliana DaCunha, BA; Phone Number: 7744730760; Email: eadacunha@bwh.harvard.edu

Study Locations

• South Africa
  • Gautang
    • Johannesburg, Gautang, South Africa
      • University of Witwatersrand Health Consortium
      • Contact: Nicholas Munro, PhD; Phone Number: 27-716073937; Email: Nick.Munro@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Control	Other: HPV Vaccine Communication Strategy; The intervention will include health promotions materials and provision of HPV vaccine
Experimental: HPV Intervention	Other: HPV Vaccine Communication Strategy; The intervention will include health promotions materials and provision of HPV vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention	Acceptability will be determined using the Acceptability of Intervention Measure.	Six Months
Feasibility of delivering the intervention	Feasibility will be assessed using the Feasibility of Intervention Measure.	Six Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary Effectiveness of the HPV intervention	We will assess HPV vaccine completion at six months	Six Months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institutes of Health (NIH)

Publications and helpful links

General Publications

• Centers for Disease Control and Prevention. Genital HPV Infection - Basic Fact Sheet. 2022. https://www.cdc.gov/std/hpv/stdfact-hpv.htm
• 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.
• South Africa: Human Papillomavirus and Related Cancers, Fact Sheet 2021. Institut Català d'Oncologia; 2021. https://hpvcentre.net/statistics/reports/ZAF_FS.pdf

Helpful Links

• Genital HPV Infection - Basic Fact Sheet by Centers for Disease Control and Prevention
• South Africa: Human Papillomavirus and Related Cancers, Fact Sheet 2021 by Institut Català d'Oncologia

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 18, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 18, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2023p001246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes