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

HPV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05919901
• Other study ID #: 2023p001246
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2025
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2023
• Source: Brigham and Women's Hospital
• Contact: Ingrid T Katz, MD, BA, MHS
• Phone: 617-525-8194
• Email: ikatz2[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years and older

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.

Related Conditions & MeSH terms

• HPV

Intervention

Other:
• HPV Vaccine Communication Strategy
The intervention will include health promotions materials and provision of HPV vaccine

Locations

Country	Name	City	State
South Africa	University of Witwatersrand Health Consortium	Johannesburg	Gautang

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

South Africa, 

References & Publications (3)

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

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the intervention	Acceptability will be determined using the Acceptability of Intervention Measure.	Six Months
Primary	Feasibility of delivering the intervention	Feasibility will be assessed using the Feasibility of Intervention Measure.	Six Months
Secondary	Preliminary Effectiveness of the HPV intervention	We will assess HPV vaccine completion at six months	Six Months

External 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