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 volunteersQualifiers
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
Other
Other
Treatments tested in this trial
Urine Sample Collection
Other interventionWhen urine is collected as a sample in either CSS or LS, first flow urine samples will be collected
Self-collected Vaginal Swab
Other interventionSelf-collected Vaginal Swab will be collected by the participant under the supervision of a trained nurse or other health care worker.
Blood Samples
Other interventionIf 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
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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International Vaccine Institute
Lead sponsor
London School of Hygiene and Tropical Medicine
Collaborator
Karolinska Institutet
Collaborator
Centers for Disease Control and Prevention
Collaborator