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NCT06144229Enrolling by invitation

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)

Source: ClinicalTrials.gov · Last updated 18 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
650 (estimated)
First submitted
16 Nov 2023
Start date
12 Nov 2024
Primary completion date
Jan 2029
Lead sponsor
University of California, Los Angeles
NCT number
NCT06144229

What you commit to

  • Study type: Observational
  • Planned participants: 650
  • From 12 Nov 2024 to the primary completion date, Jan 2029
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Women with known bleeding disorders;

Other

  • 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 unable to consent for themselves; and

Who the study is looking for

  • 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.

Age in the registry: 21 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Boston Children's Hospital
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BostonUnited StatesUnknown status
Ann & Robert H. Lurie Children's Hospital of Chicago
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ChicagoUnited StatesUnknown status
University of Colorado
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DenverUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
St. Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status
Univeristy of Miami
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MiamiUnited StatesUnknown status
Children's Hospital New Orleans
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New OrleansUnited StatesUnknown status
Bronx-Lebanon Hospital Center Health Care System
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
Jacobi Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.