Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)

ConditionHPV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age9-50
SponsorInternational Vaccine Institute

About this trial

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

This trial accepts healthy volunteers

Qualifiers

9 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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Urine Sample Collection

    Other intervention

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

  • Self-collected Vaginal Swab

    Other intervention

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

  • Blood Samples

    Other intervention

    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.

Treatment groups

29,750 Participants
are divided into 3 treatment groups
Group A: Cross-Sectional Survey1 intervention
Group B: Longitudinal Study3 interventions
Group C: Qualitative Study0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Q4 2023 to Q4 2024
2

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.

Time frame
Q4 2023 to Q4 2026

Secondary outcomes

1

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.

This study aims to provide standard data among girls and women ages 9-50 in 8 countries, 3 in South Asia, and 5 in Sub-Saharan Africa, on the burden of HPV in a representative population sample of lower socio-economic status, as well as in particular vulnerable sub-populations of girls and women depending on the country.

Time frame
Q4 2023 to Q4 2024
2

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

Countries have been selected such that there will be representation from countries with high, medium, or low HIV incidence, high and low cervical cancer incidence, those with or without HPV screening and treatment programs, and countries that are in various stages of prophylactic HPV vaccine rollout.

Time frame
Q4 2023 to Q4 2026
3

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

For each CSS and LS, study data will be summarized using descriptive statistics (mean, standard deviation, median, minimum, and maximum) for continuous variables, and counts and percentages for categorical variables. The denominator for each percentage will be the number of participants who were eligible for each CSS/LS unless otherwise specified.

Time frame
Q1 2024 to Q4 2025
4

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

For each CSS and LS, study data will be summarized using descriptive statistics (mean, standard deviation, median, minimum, and maximum) for continuous variables, and counts and percentages for categorical variables. The denominator for each percentage will be the number of participants who were eligible for each CSS/LS unless otherwise specified.

Time frame
Q1 2024 to Q4 2025

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

International Vaccine Institute

Lead sponsor

London School of Hygiene and Tropical Medicine

Collaborator

Karolinska Institutet

Collaborator

Centers for Disease Control and Prevention

Collaborator