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
- Diseases
- HIV, Cervical cancer
- 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
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Univeristy of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Children's Hospital New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Bronx-Lebanon Hospital Center Health Care System Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Jacobi Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.