Estimating the prevalence of high-risk HPV infections in women and girls across multiple countries

Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)

This study is trying to find out how common high-risk HPV infections are in girls and women aged 9-50 in different countries, especially in low-income areas.

Quick facts

• Study type: Observational
• Enrollment: 29750 (estimated)
• Ages: 9 Years to 50 Years
• Sex: Female
• Sponsor: International Vaccine Institute (Academic / other)
• Locations: 8 sites (Dhaka and 7 other locations)
• Trial ID: NCT06129253 on ClinicalTrials.gov

What this trial studies

This observational study aims to estimate the point-prevalence of high-risk HPV infections among girls and women aged 9-50 years across eight countries, including South Asian and sub-Saharan African nations. It will utilize cross-sectional surveys and longitudinal studies to gather data on HPV incidence and risk factors, with a focus on low socio-economic populations. The study will implement a harmonized protocol to ensure comparability of data, while also adapting to country-specific contexts. Qualitative sub-studies will explore gender-related dynamics affecting HPV burden and access to prevention.

Who should consider this trial

Good fit: Ideal candidates for this study are girls and women aged 9-50 years residing in selected communities of the participating countries.

Not a fit: Patients who are not residents of the selected communities or those who decline to participate will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the prevalence of high-risk HPV infections, informing public health strategies and interventions to reduce cervical cancer risk.

How similar studies have performed: Other studies have successfully estimated HPV prevalence in various populations, but this multi-country approach is relatively novel.

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.

Where this trial is running

Dhaka and 7 other locations

• Diarrhoeal Disease Research, Bangladesh (icddr,b) — Dhaka, Bangladesh (Completed)
• Institut National pour la Recherche Biomedicale (INRB) — Kinshasa, Democratic Republic of the Congo (Recruiting)
• University of Health and Allied Sciences (UHAS) — Ho, Volta Region, Ghana (Completed)
• Dhulikhel Hospital Kathmandu University Hospital (DHKUH) — Dhulikhel, Nepal (Completed)
• Aga Khan University (AKU) — Karachi, Pakistan (Completed)
• College of Medicine and Allied Health Sciences (COMAHS) — Freetown, Sierra Leone (Completed)
• Mwanza Intervention Trial Unit (MITU) — Mwanza, Tanzania (Completed)
• Zambart — Lusaka, Zambia (Completed)

Study contacts

• Principal investigator: Alexandra Hill — Associate Research Scientist
• Study coordinator: Julia Lynch

Conditions HPV Infection; HPV Positivity; High Risk HPV; Cervical Cancer