RecruitingNCT06129253

Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)

Sponsor

International Vaccine Institute

Enrollment

29,750 participants

Start Date

Nov 23, 2023

Study Type

OBSERVATIONAL

Conditions

HPV Infection

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

Sex: FEMALEMin Age: 9 YearsMax Age: 50 Years

Inclusion Criteria6

to 50 years old (for urban and rural CSSs) at the time of enrollment.
Resident in the selected community for at least the past 3 months (with the exception of pastoralists, refugees, and commercial sex workers).
Able to understand the purpose of the study and study procedures.
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.
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
If aged \<18 years (and not considered an emancipated minor), able and willing to provide assent to participate in the study.

Exclusion Criteria2

Decline consent to participate any activity of the study.
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.

Interventions

OTHERUrine Sample Collection

When urine is collected as a sample in either CSS or LS, first flow urine samples will be collected

OTHERSelf-collected Vaginal Swab

Self-collected Vaginal Swab will be collected by the participant under the supervision of a trained nurse or other health care worker.

OTHERBlood Samples

If funding permits, a blood sample may be collected from participants in LS once during the follow-up period. If blood sample collection was not feasible during a visit, two additional attempts may be made to collect blood samples from LS participants during the subsequent follow-up visits.