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The study is currently halted due to ongoing amendments following major protocol changes
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPV Intervention | Experimental |
| |
| Active Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Vaccine Communication Strategy | Other | The intervention will include health promotions materials and provision of HPV vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Effectiveness of the HPV intervention | We will assess HPV vaccine completion at six months | Six Months |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Witwatersrand Health Consortium | Johannesburg | Gautang | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Centers for Disease Control and Prevention. Genital HPV Infection - Basic Fact Sheet. 2022. https://www.cdc.gov/std/hpv/stdfact-hpv.htm | ||
| 33299640 | 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. | |
| Background | South Africa: Human Papillomavirus and Related Cancers, Fact Sheet 2021. Institut CatalĂ d'Oncologia; 2021. https://hpvcentre.net/statistics/reports/ZAF_FS.pdf |
| Label | URL |
|---|---|
| Genital HPV Infection - Basic Fact Sheet by Centers for Disease Control and Prevention | View source |
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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.
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| South Africa: Human Papillomavirus and Related Cancers, Fact Sheet 2021 by Institut CatalĂ d'Oncologia | View source |