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OpenTrials
Enrolling by Invitation

NCT Number: NCT06144229

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

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.

Enrolling by Invitation

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. Effectiveness of HPV vaccine in WLHIV

    Time frame: 3-year

    -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").

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Albert Einstein College of Medicine
  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Baylor College of Medicine
  • Bronx-Lebanon Hospital Center Health Care System
  • Children's Hospital New Orleans, LA
  • Frontier Science & Technology Research Foundation, Inc.
  • Jacobi Medical Center
  • St. Jude Children's Research Hospital
  • University of Colorado, Denver
  • University of Miami

Registry information

Official study title

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

Acronym: LiVes-LLC

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 22, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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