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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест Self-Collection HPV testing kit from Abbott
  Self-swab collection kits, participates will self-collected vaginal swab for hrHPV test (at home or in the clinic)

Первичные конечные точки

• Effectiveness of HPV vaccine in WLHIV [Срок оценки: 3-year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 9 центров

• University of Colorado — Denver
• Univeristy of Miami — Miami
• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago
• Children's Hospital New Orleans — New Orleans
• Boston Children's Hospital — Boston
• Bronx-Lebanon Hospital Center Health Care System — The Bronx
• Jacobi Medical Center — The Bronx
• St. Jude Children's research hospital — Memphis
• … и ещё 1 центр

Идентификаторы

NCT: NCT06144229 · PH700

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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