Status:
ENROLLING_BY_INVITATION
Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Frontier Science & Technology Research Foundation, Inc.
Conditions:
Hiv
Hpv
Eligibility:
FEMALE
21-40 years
Brief Summary
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 Pediatri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT06144229
Start Date
November 12 2024
End Date
November 1 2028
Last Update
August 29 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado
Denver, Colorado, United States, 13123
2
Univeristy of Miami
Miami, Florida, United States, 33136
3
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611-2991
4
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70112