Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)

NCT06129253 | Recruiting

• 1 other identifier: GLOBE-HPV-01
• Study Type: observational
• Target: 29,750
• Locations: 8 countries
• Sites: 8

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.

Conditions

HPV Infection

Keywords

HPV Positivity; HPV Infection; High Risk (HR) HPV; Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• To estimate the prevalence (single time point detection) of HPV 16 and/or 18 infection among a representative sample of girls and women aged 9-50y in a range of settings.

  HPV 16 and 18 are the most common types associated with an increased risk of cervical, anal, and other types of cancer. The incidence of HPV infection rises quickly after sexual debut and HPV infection is most common among young adults up to the age of 30, with incidence generally declining after that. The proposed age range of 9-50 years old for the CSS has been divided into four age-strata, 9-14, 15-20, 21-30, 31-50 years old, in order to understand the HPV prevalence among the age group targeted for primary series of HPV vaccine (9-14 years old), the age group targeted for multi-age cohort catch-up campaign (15-20 years old) and to gather prevalence data on older females.

  Q4 2023 to Q4 2024

• To estimate the incidence of ≥6-month persistent HPV 16 and/or 18 infection (defined as two sequential type-specific positives with an interval of 6 months) in selected populations over 2 years.

  The age range for the LS will target the age group that is anticipated to have the highest incidence (e.g. newly sexually active girls and women) or to meet the specific research needs. The progression of HPV infection can lead to the development of premalignant lesions in the epithelial lining, ranging from low-grade (CIN 1) to high-grade (CIN 2 and 3). Persistent infection with high-risk HPV genotypes can result in premalignant and malignant lesions which typically take over 10-20 years to develop. An endpoint of 6-month persistent HPV infection has been commonly used in both epidemiological studies of HPV infection and clinical trials of HPV vaccines.

  Q4 2023 to Q4 2026

Secondary Outcomes (5)

• To estimate the prevalence of high risk (HR) HPV infection among a representative sample of girls and women aged 9-50 years in a range of settings, and to evaluate potential risk factors for HPV infection.

  Q4 2023 to Q4 2024

• To estimate the incidence of ≥6-month persistent HR HPV infection in selected populations over 2 years.

  Q4 2023 to Q4 2026

• Descriptive statistics of the knowledge, attitudes, and beliefs regarding HPV vaccination, cervical cancer screening and treatment.

  Q1 2024 to Q4 2025

• Descriptive statistics of the perceptions of gender norms and stigma, and gender-related dynamics that may influence HPV burden and/or create barriers that influence girls/women's access to and uptake of HPV prevention, screening, and treatment services

  Q1 2024 to Q4 2025

• Sensitivity, specificity, Accuracy, ROC, Cohen's kappa coefficient of HPV genotyping results obtained from urine and self-collected vaginal swabs (SCVS).

  Q1 2024 to Q4 2024

Study Arms (3)

Cross-Sectional Survey

There are total 14 CSS groups among 8 participating countries: Bangladesh has 3 groups for CSS (urban CSS, rural CSS, displaced population CSS); Pakistan has 3 groups for CSS (urban CSS, rural CSS, commercial sex worker population CSS); Nepal has 1 nationally representative CSS; Sierra Leon has 1 rural CSS; Tanzania has 2 groups for CSS (pastoralists CSS, displaced population CSS); Ghana has 1 urban CSS; Zambia has 1 group for urban \& rural representative CSS; DR Congo has 2 groups for CSS (population representative sample for urban and rural CSS, displaced population CSS)

Other: Urine Sample Collection

Longitudinal Study

There are total 11 LS groups: Bangladesh has 2 LS groups (married women up to 25 years-old \& 26-35 years old); Sierra Leone has 2 LS groups (Young girls subject to child marriage/early pregnancy \& general population); Tanzania has 2 LS groups (fishing, mining/tuck stop community \& general population) Other 5 countries have 1 LS group in each country.

Other: Urine Sample Collection; Other: Self-collected Vaginal Swab; Other: Blood Samples

Qualitative Study

The qualitative sub-studies in five selected countries (Bangladesh, Nepal, Pakistan, Sierra Leone, DR Congo) will follow and draw on findings from the CSS, focusing on girls and women of different age strata as well as community members (including boys and men) and key informants in the health care system in each study site. Qualitative study methods will vary depending on the site and CSS findings, but will include both individual in- depth interviews (IDIs) (up to \~ 30 individuals per site), key informant interviews as well as multiple focus group discussions (FGDs) with \~6-8 participants/group. Detailed qualitative study methodology will be developed separately as another study protocol and adapted according to the procedures for each site.

Interventions

Urine Sample Collection OTHER

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

Cross-Sectional Survey; Longitudinal Study

Self-collected Vaginal Swab OTHER

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

Longitudinal Study

Blood Samples OTHER

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.

Longitudinal Study

Eligibility Criteria

• Age: 9 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will enroll girls and women aged 9-50 years old, with equal distribution across the following age strata: 9-14, 15-20, 21-30, and 31-50 years.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Vaccine Institute: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Karolinska Institutet: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (8)

Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, 1212, 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, 45200, Nepal

COMPLETED

Aga Khan University (AKU)

Karachi, 74800, Pakistan

COMPLETED

College of Medicine and Allied Health Sciences (COMAHS)

Freetown, Sierra Leone

COMPLETED

Mwanza Intervention Trial Unit (MITU)

Mwanza, 11936, Tanzania

COMPLETED

ZAMBART

Lusaka, Zambia

COMPLETED

Biospecimen

Retention: SAMPLES WITH DNA

1. Urine Sample When urine is collected as a sample in either CSS or LS, first flow urine samples will be collected. 2. Self-collected Vaginal Swab SCVS will be collected by the participant under the supervision of a trained nurse or other health care worker. 3. Blood Sample 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.

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alexandra Hill

  Associate Research Scientist

  PRINCIPAL INVESTIGATOR

• Deborah Watson-Jones

  Professor of Clinical Epidemiology & International Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Lynch

CONTACT

+8228811149; julia.lynch@ivi.int

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: November 13, 2023
• Study Start: November 23, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Within 6 months of completion of the project, the complete dataset and associated code will be made available in an open access platform.
• Access Criteria: Access to this study data will be controlled by a managed access process whereby access is provided only after approval of the Data Use Agreement (DUA). Long-term access is freely provided to researchers.

Locations

TA (1); DE (1); ZA (1); SI (1); GH (1); PA (1); BA (1); NE (1)