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NCT06144229 | ENROLLING BY INVITATION | Hiv

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

University of California, Los Angeles

Information provided by (Responsible Party):

Anna-Barbara Moscicki, MD

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 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.

Condition or disease

Hiv

Hpv

Intervention/treatment

Self-Collection HPV testing kit from Abbott

Study Type : OBSERVATIONAL
Estimated Enrollment : 810 participants
Official Title : Real-world Effectiveness of HPV Vaccine in Women Living with HIV and Its Impact on Cervical Cancer Screening Accuracies (LiVes LLC Study)
Actual Study Start Date : 2024-11-12
Estimated Primary Completion Date : 2028-11
Estimated Study Completion Date : 2028-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 40 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Real-world Effectiveness of HPV Vaccine in Women Living with HIV and Its Impact on Cervical Cancer Screening Accuracies

Location Details

NCT06144229

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Colorado

University of Colorado

Denver, Colorado, United States, 13123

Not yet recruiting

United States, Florida

Univeristy of Miami

Miami, Florida, United States, 33136

Not yet recruiting

United States, Illinois

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611-2991

Not yet recruiting

United States, Louisiana

Children's Hospital New Orleans

New Orleans, Louisiana, United States, 70112

Not yet recruiting

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Not yet recruiting

United States, New York

Bronx-Lebanon Hospital Center Health Care System

Bronx, New York, United States, 10457

Not yet recruiting

United States, New York

Jacobi Medical Center

Bronx, New York, United States, 10461

Not yet recruiting

United States, Tennessee

St. Jude Children's research hospital

Memphis, Tennessee, United States, 38105

Not yet recruiting

United States, Texas

Baylor college of Medicine

Houston, Texas, United States, 77030