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

Plain Language Summary

Simplified for easier understanding

This global study (GLOBE-HPV) is measuring how common HPV (human papillomavirus) infection is across different urban and rural communities around the world, using community surveys and self-collected samples. HPV is the main cause of cervical cancer and other cancers. **You may be eligible if:** - You are between 9 and 50 years old - You have lived in the selected community for at least the past 3 months - You are able to understand the study and give consent (or have a parent/guardian consent if under 18) - You are willing to participate in the sample collection **You may NOT be eligible if:** - You decline to participate - You have a medical condition or other reason that makes you ineligible in the investigator's judgment (unrelated to HPV) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.