Status:
COMPLETED
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
United States Agency for International Development (USAID)
Conditions:
HPV Infection
Cervical Cancer
Eligibility:
FEMALE
25-50 years
Phase:
NA
Brief Summary
The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) ...
Detailed Description
This is a single arm, prospective study of 1,250 women (625 HIV-positive and 625 HIV-negative) enrolled from outpatient clinics that provide sexual and reproductive health (SRH) services and/or HIV ca...
Eligibility Criteria
Inclusion
- Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening).
- Ability and willingness of participant to provide written informed consent.
Exclusion
- Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia
- Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment)
- Prior HPV vaccination.
- Participants with known allergy to acetic acid.
- Participants with a history of total hysterectomy.
- Participants who are pregnant or plan on becoming pregnant during the study period.
- Participants who are less than 12 weeks postpartum.
- Participants with other illnesses that would limit compliance with study requirements or in the opinion of the investigator or designee, have a problem that would make participation in the study unsafe or complicate interpretation of study findings.
Key Trial Info
Start Date :
June 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT04092257
Start Date
June 24 2020
End Date
February 28 2025
Last Update
August 6 2025
Active Locations (1)
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1
University of North Carolina (UNC) Project-Malawi
Lilongwe, Malawi