NCT06144229

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 810 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hiv
• Hpv

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-11-12
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2023-11-22
• Last updated: 2025-08-29

Locations

9 sites across 1 country: United States