HPV
Conditions
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.
Interventions
OTHERHPV Vaccine Communication Strategy
The intervention will include health promotions materials and provision of HPV vaccine
Sponsors
National Institutes of Health (NIH)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* This study will include children enrolled in Grade 5 in participating schools (ages 9-12 years old) in Gauteng province, 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of HPV vaccine | within Six Months | Successful uptake of 1 dose of HPV vaccine |
| Feasibility of delivering the intervention | Six Months | Feasibility will be assessed using the Feasibility of Intervention Measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary Effectiveness of the HPV intervention | Six Months | We will assess HPV vaccine completion at six months |
Countries
South Africa
Outcome results
None listed