Cervical CancerNCT05247853
HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV
An observational study of Cervical Cancer and Human Papilloma Virus, run by Montefiore Medical Center at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Human Papilloma Virus, Human Immunodeficiency Virus
- What is being tested?
- Blood collection, Oral, cervicovaginal and anal specimen collection and Anoscopy & Biopsy of Acetowhite Lesions
- Type of treatment
- Vaccines, Pill or oral medicine, Surgery or procedure
- How many people
- 3,127 participants
- Where
- 1 siteRwanda
- Study dates
- 3 Nov 2021to 12 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Human Papillomavirus Vaccination Effectiveness and Immunity in Rwandan Women Living With and Without Human Immunodeficiency Virus
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.
Read the 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. 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.
- Conditions
- Cervical Cancer, Human Papilloma Virus, Human Immunodeficiency Virus, HPV-Related Carcinoma
- Being tested
- Blood collection, Oral, cervicovaginal and anal specimen collection, Anoscopy & Biopsy of Acetowhite Lesions, Colposcopy & Biopsy of Acetowhite Lesions, Ablative Treatment
- Medical subject headings
- Uterine Cervical Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionProcedure or surgery
Blood collection at enrollment visit
Oral, cervicovaginal and anal specimen collectionProcedure or surgery
Oral, cervicovaginal and anal specimen collection at enrollment and follow-up visits
Anoscopy & Biopsy of Acetowhite LesionsProcedure or surgery
Used for management in follow-up visits of persistent anal HPV16/18+ in WLWH
Colposcopy & Biopsy of Acetowhite LesionsProcedure or surgery
Used for management in follow-up visits of persistent type-specific high-risk HPV cervicovaginal HPV
Ablative TreatmentProcedure or surgery
Use for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy
LEEP (Loop Electrosurgical Excision Procedure)Procedure or surgery
Use for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy that ablation ineligible
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | HPV-vaccinated women living with HIV Receives: 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) | |
| Group 2 | HPV-unvaccinated women living with HIV Receives: 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) | |
| Group 3 | HIV[-] women who are HPV-vaccinated Receives: Procedure: Blood collection; Procedure: Oral, cervicovaginal and anal specimen collection; Procedure: Colposcopy & Biopsy of Acetowhite Lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start3 Nov 2021
- Primary completion12 Dec 2024
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rwanda Military Hospital, University of Rwanda
- Responsible party
- Sponsor
- Investigators
- Marcel Yotebieng, MD, PhD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247853
- Sponsor's protocol ID
- 2021-13087
- Other IDs
- 1U54CA254568-01
- Status last verified
- Oct 2025
- First submitted
- 13 Jan 2022
- Last updated
- 16 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kundrod KA, Jeronimo J, Vetter B, Maza M, Murenzi G, Phoolcharoen N, Castle PE. Toward 70% cervical cancer screening coverage: Technical challenges and opportunities to increase access to human papillomavirus (HPV) testing. PLOS Glob Public Health. 2023 Aug 16;3(8):e0001982. doi: 10.1371/journal.pgph.0001982. eCollection 2023.
PubMed 37585432Murenzi G, Mungo C. Impact of the human papillomavirus vaccine in low-resource settings. Lancet Glob Health. 2023 Jul;11(7):e997-e998. doi: 10.1016/S2214-109X(23)00203-6. Epub 2023 May 16. No abstract available.
PubMed 37207682Murangwa A, Desai KT, Gage JC, Murenzi G, Tuyisenge P, Kanyabwisha F, Musafili A, Kubwimana G, Mutesa L, Anastos K, Kim HY, Castle PE. Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda. Afr J Lab Med. 2022 Oct 19;11(1):1827. doi: 10.4102/ajlm.v11i1.1827. eCollection 2022.
PubMed 36353194Murenzi G, Shumbusho F, Hansen N, Munyaneza A, Gage JC, Muhoza B, Kanyabwisha F, Pierz A, Tuyisenge P, Anastos K, Castle PE. Long-term human papillomavirus vaccination effectiveness and immunity in Rwandan women living with and without HIV: a study protocol. BMJ Open. 2022 Aug 25;12(8):e061650. doi: 10.1136/bmjopen-2022-061650.
PubMed 36008069Mukherjee A, Ye Y, Wiener HW, Kuniholm MH, Minkoff H, Michel K, Palefsky J, D'Souza G, Rahangdale L, Butler KR, Kempf MC, Sudenga SL, Aouizerat BE, Ojesina AI, Shrestha S. Variations in Genes Encoding Human Papillomavirus Binding Receptors and Susceptibility to Cervical Precancer. Cancer Epidemiol Biomarkers Prev. 2023 Sep 1;32(9):1190-1197. doi: 10.1158/1055-9965.EPI-23-0300.
PubMed 37410084
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Human Papillomavirus Vaccination Effectiveness and Immunity in Rwandan Women Living With and Without Human Immunodeficiency Virus
- ClinicalTrials.gov ID
- NCT05247853
- Acronym / sponsor ID
- 2021-13087
- Conditions
- Cervical Cancer, Human Papilloma Virus, Human Immunodeficiency Virus, HPV-Related Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,127 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rwanda Military Hospital, University of Rwanda
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | 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-vaccinated women living with HIV |
| Group 2 | – | 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 |
| Group 3 | – | Procedure: Blood collection, Procedure: Oral, cervicovaginal and anal specimen collection, Procedure: Colposcopy & Biopsy of Acetowhite LesionsHIV[-] women who are HPV-vaccinated |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionBlood collection at enrollment visit | Procedure or surgery | Group 1, Group 2, Group 3 |
| Oral, cervicovaginal and anal specimen collectionOral, cervicovaginal and anal specimen collection at enrollment and follow-up visits | Procedure or surgery | Group 1, Group 2, Group 3 |
| Anoscopy & Biopsy of Acetowhite LesionsUsed for management in follow-up visits of persistent anal HPV16/18+ in WLWH | Procedure or surgery | Group 1, Group 2 |
| Colposcopy & Biopsy of Acetowhite LesionsUsed for management in follow-up visits of persistent type-specific high-risk HPV cervicovaginal HPV | Procedure or surgery | Group 1, Group 2, Group 3 |
| Ablative TreatmentUse for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy | Procedure or surgery | Group 1, Group 2 |
| LEEP (Loop Electrosurgical Excision Procedure)Use for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy that ablation ineligible | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Change in vaccine effectiveness of prophylactic HPV vaccine
Time frame: Baseline and up to 12 months
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
Change in long-term antibody responses to HPV vaccination
Time frame: Baseline and up to 12 months
To quantify, and examine the determinants of, long-term antibody (into young adulthood) responses to HPV vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Results publication: PubMed 37585432Kundrod KA, Jeronimo J, Vetter B, Maza M, Murenzi G, Phoolcharoen N, Castle PE. Toward 70% cervical cancer screening coverage: Technical challenges and opportunities to increase access to human papillomavirus (HPV) testing. PLOS Glob Public Health. 2023 Aug 16;3(8):e0001982. doi: 10.1371/journal.pgph.0001982. eCollection 2023.
- Results publication: PubMed 37207682Murenzi G, Mungo C. Impact of the human papillomavirus vaccine in low-resource settings. Lancet Glob Health. 2023 Jul;11(7):e997-e998. doi: 10.1016/S2214-109X(23)00203-6. Epub 2023 May 16. No abstract available.
- Results publication: PubMed 36353194Murangwa A, Desai KT, Gage JC, Murenzi G, Tuyisenge P, Kanyabwisha F, Musafili A, Kubwimana G, Mutesa L, Anastos K, Kim HY, Castle PE. Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda. Afr J Lab Med. 2022 Oct 19;11(1):1827. doi: 10.4102/ajlm.v11i1.1827. eCollection 2022.
- Results publication: PubMed 36008069Murenzi G, Shumbusho F, Hansen N, Munyaneza A, Gage JC, Muhoza B, Kanyabwisha F, Pierz A, Tuyisenge P, Anastos K, Castle PE. Long-term human papillomavirus vaccination effectiveness and immunity in Rwandan women living with and without HIV: a study protocol. BMJ Open. 2022 Aug 25;12(8):e061650. doi: 10.1136/bmjopen-2022-061650.
- Results publication: PubMed 37410084Mukherjee A, Ye Y, Wiener HW, Kuniholm MH, Minkoff H, Michel K, Palefsky J, D'Souza G, Rahangdale L, Butler KR, Kempf MC, Sudenga SL, Aouizerat BE, Ojesina AI, Shrestha S. Variations in Genes Encoding Human Papillomavirus Binding Receptors and Susceptibility to Cervical Precancer. Cancer Epidemiol Biomarkers Prev. 2023 Sep 1;32(9):1190-1197. doi: 10.1158/1055-9965.EPI-23-0300.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Yotebieng, MD, PhD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Human Papilloma Virus, run by Montefiore Medical Center at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in vaccine effectiveness of prophylactic HPV vaccine (time frame: Baseline and up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247853, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.