HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV

NCT05247853 | Completed

• 2 other identifiers: 2021-130871U54CA254568-01
• Study Type: observational
• Target: 3,127
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer; Human Papilloma Virus; Human Immunodeficiency Virus; HPV-Related Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline and up to 12 months

Other Outcomes (1)

• Change in HPV natural history study at 6 months

  Baseline and 6 months

Study Arms (3)

Group 1

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)

Group 2

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)

Group 3

HIV\[-\] women who are HPV-vaccinated

Procedure: Blood collection; Procedure: Oral, cervicovaginal and anal specimen collection; Procedure: Colposcopy & Biopsy of Acetowhite Lesions

Interventions

Blood collection PROCEDURE

Blood collection at enrollment visit

Group 1; Group 2; Group 3

Oral, cervicovaginal and anal specimen collection PROCEDURE

Oral, cervicovaginal and anal specimen collection at enrollment and follow-up visits

Group 1; Group 2; Group 3

Anoscopy & Biopsy of Acetowhite Lesions PROCEDURE

Used for management in follow-up visits of persistent anal HPV16/18+ in WLWH

Group 1; Group 2

Colposcopy & Biopsy of Acetowhite Lesions PROCEDURE

Used for management in follow-up visits of persistent type-specific high-risk HPV cervicovaginal HPV

Group 1; Group 2; Group 3

Ablative Treatment PROCEDURE

Use for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy

Group 1; Group 2

LEEP (Loop Electrosurgical Excision Procedure) 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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Female
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Cancer Institute (NCI): collaborator
• Rwanda Military Hospital: collaborator
• University of Rwanda: collaborator

Study Sites (1)

Rwanda Military Hospital

Kigali, Rwanda

Location

Related Publications (5)

• 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.

  PMID: 37585432 RESULT

• Murenzi 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.

  PMID: 37207682 RESULT

• Murangwa 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.

  PMID: 36353194 RESULT

• Murenzi 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.

  PMID: 36008069 RESULT

• Mukherjee 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.

  PMID: 37410084 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

De-identified pictures of participants' cervix, blood collection, oral swab specimen, cervical swab specimen and anal swab specimen

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Acquired Immunodeficiency Syndrome

Interventions

Blood Specimen Collection; Proctoscopy; Colposcopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Obstetrical and Gynecological; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Marcel Yotebieng, MD, PhD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 21, 2022
• Study Start: November 3, 2021
• Primary Completion: December 12, 2024
• Study Completion: December 12, 2024
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)