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

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of California, Los Angeles
Study ID
NCT06144229
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 12, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
650 participants (estimated)

Primary Outcome Measure

Effectiveness of HPV vaccine in WLHIV [ Time Frame: 3-year ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of ColoradoDenverColorado13123-
Univeristy of MiamiMiamiFlorida33136-
Ann & Robert H Lurie Children's Hospital of ChicagoChicagoIllinois60611-2991-
Children's Hospital New OrleansNew OrleansLouisiana70112-
Boston Children's HospitalBostonMassachusetts02115-
Bronx-Lebanon Hospital Center Health Care SystemThe BronxNew York10457-
Jacobi Medical CenterThe BronxNew York10461-
St. Jude Children's research hospitalMemphisTennessee38105-
Baylor college of MedicineHoustonTexas77030-

Find similar trials in Denver, CO

By condition
HIV
By specialty
Infectious disease
By research site
University of Colorado· Denver, COUniveristy of Miami· Miami, FLAnn & Robert H Lurie Children's Hospital of Chicago· Chicago, ILChildren's Hospital New Orleans· New Orleans, LABoston Children's Hospital· Boston, MABronx-Lebanon Hospital Center Health Care System· The Bronx, NY

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