NCT05247853Completed
HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV
Long-Term Human Papillomavirus Vaccination Effectiveness and Immunity in Rwandan Women Living With and Without Human Immunodeficiency Virus
Source: ClinicalTrials.gov · Last updated 16 Oct 2025
Brief summary (registry, in English)
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 HPV-unvaccinated Rwandan WLWH aged 18-26 years. Additional objectives include the quantification \& examination of long-term antibody (into young adulthood) responses to HPV vaccination and to validate the performance (e.g., sensitivity and specificity) of a low-cost, POC (point-of-care) anti-HPV16 antibody test to determine/confirm HPV vaccination status. The findings for this study will provide necessary evidence regarding the long-term protection afforded by HPV vaccination in WLWH living in SSA, who are at the greatest risk of HPV-related cancers.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3127 (actual)
- First submitted
- 13 Jan 2022
- Start date
- 3 Nov 2021
- Primary completion date
- 12 Dec 2024
- Lead sponsor
- Montefiore Medical Center
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT05247853
What you commit to
- Study type: Observational
- Participants enrolled: 3127
- From 3 Nov 2021 to the primary completion date, 12 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Report no previous sexual activity
Other illness
- History of hysterectomy and no longer have a cervix
- History of treatment for cervical abnormalities after cervical screening
- History of cervical cancer
- HIV status is unknown, and date of birth is 12/31/1995 or earlier
Age
- 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.
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to 28 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rwanda Military Hospital Coordinator of this site? Confirm its status | Kigali | Rwanda | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.