Status:
COMPLETED
HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Rwanda Military Hospital
Conditions:
Cervical Cancer
Human Papilloma Virus
Eligibility:
FEMALE
18-28 years
Brief Summary
Our study will assess and measure population effectiveness of prophylactic HPV vaccine in reducing cervical, anal, and/or oral prevalent and 6-month persistent infections among HPV-vaccinated and 757 ...
Detailed Description
Cervical cancer is the 4th most common cancer and cause of cancer-related death in women globally; in many lower-resource settings, especially sub-Saharan Africa (SSA), it is the most common. Virtuall...
Eligibility Criteria
Inclusion
- Female
- 18-28 years. The age of inclusion criteria will likely be restricted as age-specific enrollment goals are met.
- Physically and mentally able and willing to participate in the study.
- Willing to provide written and signed or thumb printed, informed consent.
- Known to be living with HIV (i.e., enrolled in a treatment program), or consent to HIV testing to confirm HIV status.
Exclusion
- Have positive pregnancy test or report to be pregnant at the time of visit or less than 6 weeks post-partum (will be asked to make an appointment 6 or more weeks post-partum)
- Report to be menstruating at the time of visit (will be asked to make new appointment)
- History of hysterectomy and no longer have a cervix
- History of treatment for cervical abnormalities after cervical screening
- History of cervical cancer
- Report no previous sexual activity
- HIV status is unknown, and date of birth is 12/31/1995 or earlier
- Because this study has age-specific enrollment goals for WLWH and HIV\[-\] women, once those enrollment goals are met for each study group, the respective cohorts will be closed and other eligible women will be excluded.
Key Trial Info
Start Date :
November 3 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
3127 Patients enrolled
Trial Details
Trial ID
NCT05247853
Start Date
November 3 2021
End Date
December 12 2024
Last Update
October 16 2025
Active Locations (1)
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1
Rwanda Military Hospital
Kigali, Rwanda