Human Papillomavirus Infection Clinical Trials

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Global Burden Estimation of Human Papillomavirus (GLOBE-HPV)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 9
Maximum Age: 50
Healthy Volunteers: t
View:

• 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.

• 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.

Locations
Other Locations
Bangladesh
Diarrhoeal Disease Research, Bangladesh (icddr,b)
COMPLETED
Dhaka
Democratic Republic of the Congo
Institut National pour la Recherche Biomedicale (INRB)
RECRUITING
Kinshasa
Ghana
University of Health and Allied Sciences (UHAS)
COMPLETED
Ho
Nepal
Dhulikhel Hospital Kathmandu University Hospital (DHKUH)
COMPLETED
Dhulikhel
Pakistan
Aga Khan University (AKU)
COMPLETED
Karachi
Sierra Leone
College of Medicine and Allied Health Sciences (COMAHS)
COMPLETED
Freetown
United Republic of Tanzania
Mwanza Intervention Trial Unit (MITU)
COMPLETED
Mwanza
Zambia
ZAMBART
COMPLETED
Lusaka
Contact Information
Primary
Julia Lynch
julia.lynch@ivi.int
+8228811149
Time Frame
Start Date: 2023-11-23
Estimated Completion Date: 2027-12
Participants
Target number of participants: 29750
Treatments
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)
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention, Karolinska Institutet, London School of Hygiene and Tropical Medicine
Leads: International Vaccine Institute

This content was sourced from clinicaltrials.gov