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

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

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)

Sponsors & Collaborators

• Frontier Science & Technology Research Foundation, Inc.

  collaborator INDUSTRY

• Albert Einstein College of Medicine

  collaborator OTHER

• St. Jude Children's Research Hospital

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Bronx-Lebanon Hospital Center Health Care System

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Children's Hospital New Orleans, LA

  collaborator OTHER

• Jacobi Medical Center

  collaborator OTHER

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Anna-Barbara Moscicki, MD · University of California, Los Angeles

• Denise L Jacobson, PhD,MPH · Harvard School of Public Health (HSPH)

• Howard D Strickler, MD, MPH · Albert Einstein College of Medicine

• Tzy-Jyun Yao, PhD · Harvard School of Public Health (HSPH)

Eligibility

Min Age

21 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-12

Primary Completion

2029-01-31

Completion

2029-01-31

Countries

• United States

Study Locations