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Abstract
Introduction Prophylactic human papillomavirus (HPV) vaccines have been shown to be highly effective in protecting women against cervical infections, high-grade abnormalities and cancer caused by the targeted HPV types. However, the evidence for their effectiveness in women living with HIV (WLWH) is less clear.
Methods WLWH and HIV-negative women who likely did (birth cohorts 1996 and later) and WLWH and HIV(−) negative who likely did not (birth cohorts before 1996) receive HPV vaccination (n=3028; 757 participants for each of the four groups). Between groups, we will compare cervicovaginal, anal and oral prevalent and 6–12 month persistent HPV6/11/16/18 infections as measured using a modified AmpFire HPV genotyping assay that tests for 15 high-risk or intermediate-risk HPV genotypes, HPV6 and HPV11. We will also compare the HPV immune response in HPV-vaccinated WLWH to HPV-vaccinated HIV-negative women using an anti-HPV16 and anti-HPV18 ELISA. Vaccination status will be confirmed through national vaccination records.
Analysis We will calculate point prevalence and prevalence of 6–12 month persisting infections by individual HPV-type specific infections and groups of infections for each anatomic site and for each group of women. Results will be stratified by age at vaccination, age at enrolment and the number of doses (3 vs 2) as well as other factors possibly associated with HPV prevalence. Differences in endpoints between groups, overall and between subgroups, will be tested for statistical significance (p<0.05) using Fisher’s exact or Pearson χ2 test. Differences in geometric mean titres and seropositivity will be tested for statistical significance using the Mann-Whitney and Fisher’s exact tests, respectively.
Ethics and dissemination The study was approved by the Albert Einstein College of Medicine Institutional Review Board and the Rwanda National Ethics Committee. Results will be disseminated through publication in peer-reviewed journals.
- public health
- preventive medicine
- public health
- virology
- HIV & AIDS
- gynaecology
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Footnotes
GM and FS are joint first authors.
KA and PEC are joint senior authors.
Twitter @GadMurenzi, @patrickfils
Contributors GM, PEC and KA designed the study initially. GM, AP, PEC and KA refined and finalised the overall study design and wrote the grant proposal that is the basis for this protocol. GM, FS, NH, AM, JCG, AP, KA and PEC drafted and finalised the written protocol. All authors implemented it. PEC drafted this manuscript. All authors have read, revised and approved the final manuscript. GM and FS are cofirst authors; KA and PEC are cosenior authors.
Funding This work is being supported by the National Institutes of Health (NIH) by grant numbers 5U54CA254568-02 and 2U01AI096299-13. This work is also being supported by the intramural research program of the National Cancer Institute (NCI)/NIH.
Competing interests PEC is the Director of the Division of Cancer Prevention at the NCI, the NIH institute that funds this research. However, PEC has recused himself from any decisional or financial authority over this grant or any extramural HPV grants funded by the NCI. Other authors claim no competing interests. The study is receiving HPV genotyping tests at a reduce cost from Atila Biosystems.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.