HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV (NCT05247853) | Clinical Trial Compass
CompletedNot Applicable
HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV
Rwanda3,127 participantsStarted 2021-11-03
Plain-language 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 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.
Who can participate
Age range
18 Years – 28 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in vaccine effectiveness of prophylactic HPV vaccine
Timeframe: Baseline and up to 12 months
2
Change in long-term antibody responses to HPV vaccination