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.
Study Type
OBSERVATIONAL
Enrollment
810
Self-swab collection kits, participates will self-collected vaginal swab for hrHPV test (at home or in the clinic)
University of Colorado
Denver, Colorado, United States
Univeristy of Miami
Miami, Florida, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Bronx-Lebanon Hospital Center Health Care System
The Bronx, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
St. Jude Children's research hospital
Memphis, Tennessee, United States
Baylor college of Medicine
Houston, Texas, United States
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").
Time frame: 3-year
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