Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies

Study Overview
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Brief Summary
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This study will examine both Human papillomavirus (HPV) vaccine effectiveness and Primary high-risk HPV PHS screening triage strategies in women living with HIV (WLHIV) by partnering with the Pediatric HIV/AIDs Cohort Study (PHACS) led, in part, by our investigative team. Among WWH, the study will examine the effectiveness of the HPV vaccine The study will screen approximately 810 WWH using a self-sampling kit and those who are PHS[+] will attend a clinical visit to have colposcopy/biopsy and 4 triage tests. WWH with <CIN 2+ are asked to return annually for colposcopy and HPV genotyping for up to 3 yrs. WWH PHS[-] will be asked to return in Year 2 for rescreening. Those PHS[+] will be followed as above and PHS[-] will be asked to obtain self-collected vaginal samples for HPV genotyping annually for 3 years.

Official Title
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Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies (LiVes LLC Study)

Conditions
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Hiv, Hpv

Intervention / Treatment
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* Diagnostic Test: HPV test using Evalyn Brush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years of age and less than or equal to 40 years of age; WLHIV regardless of mode of transmission or HPV vaccination status; Current enrollment in the Pediatric HIV/AIDS Cohort Study (PHACS),Surveillance Monitoring for ART Toxicities (SMARTT), Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up), Adolescent Master Protocol for Participants 18 Years of Age and Older - Lite (AMP Up Lite), or Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) studies; Willing to participate and able to provide informed consent; Willing to grant access to other PHACS/HOPE data; and Willing to provide access to medical records. Exclusion Criteria: Currently known to be pregnant via self-report at hrHPV screening for initial consent; Special consideration: Women who test positive on urine pregnancy test at the baseline colposcopy visit will be asked to defer their colposcopy until after 6 weeks following the end of the pregnancy. However, pregnancy during follow-up will be allowed, and guidelines for endocervical curettage (ECC) and treatment will be followed.39 Women known to have active CIN 2 or greater, undergoing active surveillance with colposcopy (per participant report); Women with known bleeding disorders; Women unable to consent for themselves; and Women with a hysterectomy with removal of the cervix will be excluded from the study and, if such a procedure is conducted during the participant's study enrollment, the individual will be censored from analysis at the last visit prior to the hysterectomy and taken off-study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: HPV test using Evalyn Brush|Self-swab collection kits, participates will self-collected vaginal swab for hrHPV test (at home or in the clinic)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of HPV vaccine in WLHIV | -3-year cumulative risk of (i) vaccine-hrHPV types that persist 12 months or longer, and (ii) histologic (h) CIN 2+ (CIN 2+ throughout the protocol means CIN 2 and worse). | 3-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV vaccine effectiveness among those living with HIV, Biomarker evaluation for triage of primary HPV cervical cancer screening.