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Enrolling by invitation NCT06144229

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

— Observational Hiv Hpv

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-Collection HPV testing kit from Abbott.
Who it may be relevant to
Registry conditions: Hiv, Hpv. Basic parameters: 21 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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)

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 9 centers
  • University of Colorado — Denver
  • Univeristy of Miami — Miami
  • Ann & Robert H Lurie Children's Hospital of Chicago — Chicago
  • Children's Hospital New Orleans — New Orleans
  • Boston Children's Hospital — Boston
  • Bronx-Lebanon Hospital Center Health Care System — The Bronx
  • Jacobi Medical Center — The Bronx
  • St. Jude Children's research hospital — Memphis
  • … and 1 more center

Identifiers

NCT: NCT06144229 · PH700

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗