Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies
NCT ID: NCT06144229
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
810 participants
OBSERVATIONAL
2024-11-12
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
40 Years
FEMALE
No
Sponsors
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Harvard School of Public Health (HSPH)
OTHER
Frontier Science & Technology Research Foundation, Inc.
INDUSTRY
Albert Einstein College of Medicine
OTHER
Boston Children's Hospital
OTHER
St. Jude Children's Research Hospital
OTHER
University of Colorado, Denver
OTHER
Bronx-Lebanon Hospital Center Health Care System
OTHER
University of Miami
OTHER
Baylor College of Medicine
OTHER
Children's Hospital New Orleans, LA
OTHER
Jacobi Medical Center
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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Anna-Barbara Moscicki, MD
Principal Investigator
Principal Investigators
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Anna-Barbara Moscicki, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Denise L Jacobson, PhD,MPH
Role: STUDY_CHAIR
Harvard School of Public Health (HSPH)
Howard D Strickler, MD, MPH
Role: STUDY_CHAIR
Albert Einstein College of Medicine
Tzy-Jyun Yao, PhD
Role: STUDY_CHAIR
Harvard School of Public Health (HSPH)
Locations
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University of Colorado
Denver, Colorado, United States
Univeristy of Miami
Miami, Florida, United States
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Bronx-Lebanon Hospital Center Health Care System
The Bronx, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
St. Jude Children's research hospital
Memphis, Tennessee, United States
Baylor college of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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PH700
Identifier Type: -
Identifier Source: org_study_id
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