Clinical trial NCT05919901: Multi-level School-based Intervention to Improve HPV Vaccine Uptake and Completion in South Africa
Official title: Multi-level School-based Intervention to Improve HPV Vaccine Uptake and Completion in South Africa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: HPV
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-06-26
Enrollment: 600
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of the intervention
timeFrame: Six Months
measure: Feasibility of delivering the intervention
timeFrame: Six Months
Secondary outcomes:
measure: Preliminary Effectiveness of the HPV intervention
timeFrame: Six Months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: University of Witwatersrand Health Consortium
state: Gautang
Study officials:
References:
citation: Centers for Disease Control and Prevention. Genital HPV Infection - Basic Fact Sheet. 2022. https://www.cdc.gov/std/hpv/stdfact-hpv.htm
citation: 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.
citation: South Africa: Human Papillomavirus and Related Cancers, Fact Sheet 2021. Institut Català d'Oncologia; 2021. https://hpvcentre.net/statistics/reports/ZAF_FS.pdf