An observational study in Cervical Cancer, Human Papilloma Virus and Human Immunodeficiency Virus, sponsored by Montefiore Medical Center. Completed at 1 site in Rwanda. Open to female participants aged 18 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by Montefiore Medical Center · Observational
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.
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. Virtually all cervical cancer and precancer are caused by 12-15 high-risk human papillomavirus (HPV) types. HPV16 causes approximately 55-60% and HPV18 causes approximately 10-15% of cervical cancer while the remaining 12 HPV types cause the remaining 25-30% of cervical cancer. High-risk HPV, predominately HPV16, also causes most anal, vulvar, vaginal, and penile cancers and a significant proportion of oropharyngeal cancers. Prophylactic HPV vaccines have been developed and have been shown to be nearly 100% protective against incident HPV infection and related abnormalities in the general population. However, the evidence for the effectiveness of prophylactic HPV vaccines in women living with human immunodeficiency virus (HIV) (WLWH) is less clear. HIV infection increases the risk of cervical cancer due to an impaired immune response to HPV.
Rwanda is a high-burden cervical cancer country where the prevalence of HIV is 3.7% among adult women, with higher HIV prevalence among young women (1). In 2011, Rwanda implemented a national HPV vaccination program with Gardasil®, which protects against HPV16 and HPV18, the two HPV types that cause \~70% of cervical cancer, and HPV6 and HPV11, the two types that cause \~90% of anogenital warts (HPV6/11/16/18). Their program has achieved >90% coverage of the target population, primarily girls aged 12 years, annually. The implementation of a highly successful HPV vaccination program and the high prevalence of HIV, in addition to the research and medical capacity that Albert Einstein College of Medicine (Einstein) has helped to build at the Rwanda Military Hospital (RMH) and University of Rwanda (UR), makes Rwanda the ideal locale to study the long-term effects of HPV vaccination in WLWH.
To answer questions about HPV vaccine effectiveness and immunity in Rwandan WLWH, collaborators at Einstein, RMH, and UR will conduct an observational study of WLWH and HIV-negative (HIV[-]) women who did (birth cohorts 1997 and later) and WLWH who did not (birth cohorts before 1997) receive HPV vaccination through the national vaccination program. The investigators will compare cervicovaginal, anal, and oral prevalent and 6-month persistent HPV6/11/16/18 infections in 757 HPV-vaccinated WLWH to those in 757 unvaccinated WLWH and 757 HPV-vaccinated HIV[-] women. The investigators will also compare the HPV immune response in 548 HPV-vaccinated WLWH to 548 HPV-vaccinated HIV[-] women and the impact of switching from 3 doses to 2 doses of Gardasil® in 2015. Finally, the investigators will investigate the risk factors, including the cervicovaginal microbiome, for prevalent and 6-month persistent HPV infection in young WLWH and HIV[-] women. The long-term goal is to establish a cohort of WLWH in whom we can examine the long-term effectiveness of HPV vaccination in WLWH now and in the future. This contribution is significant as it will establish the population effectiveness of HPV vaccination in WLWH living in SSA, the group of women at the highest risk of cervical cancer, for which there is a dearth of evidence. The proposed research is innovative as it leverages and expands the local research and medical capacity in Rwanda to examine one of the critically unanswered questions about HPV vaccine effectiveness in the context of the World Health Organization's (WHO) call for the elimination of cervical cancer.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's enrollment of 3,127 is above the median of 225 across 529 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HPV-vaccinated women living with HIV
Procedure: Blood collection · Procedure: Oral, cervicovaginal and anal specimen collection · Procedure: Anoscopy & Biopsy of Acetowhite Lesions · Procedure: Colposcopy & Biopsy of Acetowhite Lesions · Procedure: Ablative Treatment · Procedure: LEEP (Loop Electrosurgical Excision Procedure)
HPV-unvaccinated women living with HIV
Procedure: Blood collection · Procedure: Oral, cervicovaginal and anal specimen collection · Procedure: Anoscopy & Biopsy of Acetowhite Lesions · Procedure: Colposcopy & Biopsy of Acetowhite Lesions · Procedure: Ablative Treatment · Procedure: LEEP (Loop Electrosurgical Excision Procedure)
HIV\[-\] women who are HPV-vaccinated
Procedure: Blood collection · Procedure: Oral, cervicovaginal and anal specimen collection · Procedure: Colposcopy & Biopsy of Acetowhite Lesions
Blood collection at enrollment visit
Oral, cervicovaginal and anal specimen collection at enrollment and follow-up visits
Used for management in follow-up visits of persistent anal HPV16/18+ in WLWH
Used for management in follow-up visits of persistent type-specific high-risk HPV cervicovaginal HPV
Use for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy
Use for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy that ablation ineligible
Change in vaccine effectiveness of prophylactic HPV vaccine
To measure population effectiveness of prophylactic HPV vaccine in reducing cervicovaginal, anal, and/or oral prevalent and 6-12 month persistent infections by HPV6/11/16/18
Time frame: Baseline and up to 12 months
Change in long-term antibody responses to HPV vaccination
To quantify, and examine the determinants of, long-term antibody (into young adulthood) responses to HPV vaccination
Time frame: Baseline and up to 12 months
Change in HPV natural history study at 6 months
Conduct a natural history study to investigate determinants, including cervicovaginal microbiome (CVM), of short-term HPV persistence in young WLWH and HIV\[-\] women living in a SSA setting
Time frame: Baseline and 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2021 to primary completion in Dec 2024, 37 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.