HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV

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.

Sex

Female

Minimum age

18 Years

Maximum age

28 Years

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.

• RESULTKundrod 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
• RESULTMurenzi 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
• RESULTMurangwa 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
• RESULTMurenzi 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
• RESULTMukherjee 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