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

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

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 Overview

• Status: Enrolling by invitation
• Conditions: Hiv; Hpv
• Intervention / Treatment: Diagnostic test: Self-Collection HPV testing kit from Abbott

• Study Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 13123
      • University of Colorado
  • Florida
    • Miami, Florida, United States, 33136
      • Univeristy of Miami
  • Illinois
    • Chicago, Illinois, United States, 60611-2991
      • Ann & Robert H Lurie Children's Hospital of Chicago
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Children's Hospital New Orleans
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • New York
    • The Bronx, New York, United States, 10461
      • Jacobi Medical Center
    • The Bronx, New York, United States, 10457
      • Bronx-Lebanon Hospital Center Health Care System
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Approximately 810 WLHIV greater than or equal to 21 years of age to less than or equal to 40 years of age who are current participants in PHACS (SMARTT, AMP Up, and AMP Up Lite) or HOPE will be tested for hrHPV using a Food and Drug Administration (FDA)-approved primary hrHPV screening test from self-collected specimens.

Description

Inclusion Criteria:

• At least 21 years of age and less than or equal to 40 years of age;
• WLHIV regardless of mode of transmission or HPV vaccination status;
• Current enrollment in the Pediatric HIV/AIDS Cohort Study (PHACS),Surveillance Monitoring for ART Toxicities (SMARTT), Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up), Adolescent Master Protocol for Participants 18 Years of Age and Older - Lite (AMP Up Lite), or Health Outcomes around Pregnancy and Exposure to HIV/ARVs (HOPE) studies;
• Willing to participate and able to provide informed consent;
• Willing to grant access to other PHACS/HOPE data; and
• Willing to provide access to medical records.

Exclusion Criteria:

• Currently known to be pregnant via self-report at hrHPV screening for initial consent;
• Special consideration: Women who test positive on urine pregnancy test at the baseline colposcopy visit will be asked to defer their colposcopy until after 6 weeks following the end of the pregnancy. However, pregnancy during follow-up will be allowed, and guidelines for endocervical curettage (ECC) and treatment will be followed.39
• Women known to have active CIN 2 or greater, undergoing active surveillance with colposcopy (per participant report);
• Women with known bleeding disorders;
• Women unable to consent for themselves; and
• Women with a hysterectomy with removal of the cervix will be excluded from the study and, if such a procedure is conducted during the participant's study enrollment, the individual will be censored from analysis at the last visit prior to the hysterectomy and taken off-study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	3-year

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: University of Colorado, Denver; Baylor College of Medicine; Albert Einstein College of Medicine; University of Miami; St. Jude Children's Research Hospital; Ann & Robert H Lurie Children's Hospital of Chicago; Jacobi Medical Center; Frontier Science & Technology Research Foundation, Inc.; Bronx-Lebanon Hospital Center Health Care System; Children's Hospital New Orleans, LA
• Investigators: Principal Investigator: Anna-Barbara Moscicki, MD, University of California, Los Angeles; Study Chair: Denise L Jacobson, PhD,MPH, Harvard School of Public Health (HSPH); Study Chair: Howard D Strickler, MD, MPH, Albert Einstein College of Medicine; Study Chair: Tzy-Jyun Yao, PhD, Harvard School of Public Health (HSPH)

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: HPV vaccine effectiveness among those living with HIV; Biomarker evaluation for triage of primary HPV cervical cancer screening.
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; DNA Virus Infections; Slow Virus Diseases; Tumor Virus Infections; HIV Infections; Pathological Conditions, Signs and Symptoms; Acquired Immunodeficiency Syndrome; Papillomavirus Infections
• Other Study ID Numbers: PH700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No