HPV Vaccine's Long-Term power tested in rwandan women
NCT ID NCT05247853
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study looked at how well the HPV vaccine protects against HPV infections over time in over 3,000 Rwandan women aged 18-28, some living with HIV and some without. Researchers collected blood, oral, and other samples to measure vaccine effectiveness and long-term antibody levels. They also tested a low-cost, point-of-care antibody test to see if it can confirm HPV vaccination status.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could confirm that the HPV vaccine provides long-lasting protection for women with HIV, and validate a cheap test to check vaccination status.
- What could go wrong
- This is an observational study, not a treatment trial. Results may not apply to other populations, and the low-cost test might not be accurate enough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
3,127 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will recruit women attending collaborating clinics and women from the communities surrounding those clinics into three groups: HPV-vaccinated WLWH (Group 1); HPV-unvaccinated WLWH (Group 2); and HIV\[-\] women who are HPV-vaccinated (Group 3). The number of doses of HPV vaccination received is dictated by introduction of HPV vaccination in Rwanda. In general, most Rwandan women born in 2003 or later will have been vaccinated with two doses of Gardasil®, women born between 1996 and 2002 will have been vaccinated with three doses of Gardasil®, and women born in 1995 or earlier will be unvaccinated. Therefore, we will recruit by age, which will serve as a useful and very good proxy for HPV vaccination status, which otherwise would be difficult to confirm in real time at enrollment.
- Ages
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18 to 28 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Rwanda Military Hospital
Kigali, Rwanda
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