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

Study Overview
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Brief Summary
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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.

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

Conditions
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HPV

Intervention / Treatment
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* Other: HPV Vaccine Communication Strategy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV Intervention<br> | Other: HPV Vaccine Communication Strategy<br>* The intervention will include health promotions materials and provision of HPV vaccine<br>|
| Active Comparator: Active Control<br> | Other: HPV Vaccine Communication Strategy<br>* The intervention will include health promotions materials and provision of HPV vaccine<br>|

What is the study measuring?
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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 |