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ENROLLING BY INVITATION
NCT06144229

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

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

FEMALE

Age Range

21 Years - 40 Years

Study Type

OBSERVATIONAL

Enrollment

810

Start Date

2024-11-12

Completion Date

2028-11

Last Updated

2025-08-29

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

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)

Locations (9)

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