NCT06129253 Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)
| NCT ID | NCT06129253 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Vaccine Institute |
| Condition | HPV Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 29,750 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 29,750 participants in total. It began in 2023-11-23 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multi-country and multi-site project to estimate the point-prevalence of high-risk (HR) HPV genotype infections among representative samples of girls and women aged 9-50 years, and among specific sub-populations to estimate the incidence of persistent HPV infection among sexually active young women. The data to fulfill the objectives will be collected through a series of Cross-Sectional Surveys (CSS) and Longitudinal Studies (LS) in all 8 countries 3 South Asian countries including Bangladesh, Pakistan, Nepal and 5 sub-Saharan African countries including Sierra Leone, Tanzania, Ghana, Zambia and DR Congo. Qualitative sub-studies (QS) will be conducted in selected countries and populations following the CSS to further understand and unpack risk factors for HPV infection as well as to explore how gender-related dynamics including perceptions of gender norms and stigma, influence HPV burden and/or create barriers that shape girls/women access to and uptake of HPV prevention, screening, and treatment services. Specific study protocols and corresponding ethical applications for the qualitative sub-studies will be developed separately.
Eligibility Criteria
Inclusion Criteria: 1. 9 to 50 years old (for urban and rural CSSs) at the time of enrollment. 2. Resident in the selected community for at least the past 3 months (with the exception of pastoralists, refugees, and commercial sex workers). 3. Able to understand the purpose of the study and study procedures. 4. If aged 18 years or older or legally considered an emancipated minor, able and willing to provide consent to participate in the study including sample collection. 5. If aged \<18 years (and not considered an emancipated minor), supported in their participation by a parent or guardian who is able and willing to provide consent, and 6. If aged \<18 years (and not considered an emancipated minor), able and willing to provide assent to participate in the study. Exclusion Criteria: 1. Decline consent to participate any activity of the study. 2. A medical condition or other reason, not directly related to HPV infection or HPV-related diseases, in the opinion of the investigator, precludes enrolment in the study.
Contact & Investigator
Alexandra Hill
PRINCIPAL INVESTIGATOR
Associate Research Scientist
Frequently Asked Questions
Who can join the NCT06129253 clinical trial?
This trial is open to female participants only, aged 9 Years or older, up to 50 Years, studying HPV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06129253 currently recruiting?
Yes, NCT06129253 is actively recruiting participants. Contact the research team at julia.lynch@ivi.int for enrollment information.
Where is the NCT06129253 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh, Kinshasa, Democratic Republic of the Congo, Ho, Ghana, Dhulikhel, Nepal and 4 additional locations.
Who is sponsoring the NCT06129253 clinical trial?
NCT06129253 is sponsored by International Vaccine Institute. The principal investigator is Alexandra Hill at Associate Research Scientist. The trial plans to enroll 29,750 participants.