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

Hiv Clinical Trial

— LiVes-LLC  

Official title:

Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies (LiVes LLC Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06144229
• Other study ID #: PH700
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: April 2028

Study information

• Verified date: November 2023
• Source: University of California, Los Angeles
• Contact: Anna-Barbara Moscicki, MD
• Phone: (310) 206-6345
• Email: amoscicki[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 810
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hiv
• Hpv
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• HPV test using Evalyn Brush
Self-swab collection kits, participates will self-collected vaginal swab for hrHPV test (at home or in the clinic)

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Bronx-Lebanon Hospital Center Health Care System	Bronx	New York
United States	Jacobi Medical Center	Bronx	New York
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	University of Colorado	Denver	Colorado
United States	Baylor college of Medicine	Houston	Texas
United States	St. Jude Children's research hospital	Memphis	Tennessee
United States	Univeristy of Miami	Miami	Florida
United States	Children's Hospital New Orleans	New Orleans	Louisiana

Sponsors (14)

Lead Sponsor

Collaborator

University of California, Los Angeles

Albert Einstein College of Medicine, Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, Boston Children's Hospital, Bronx-Lebanon Hospital Center Health Care System, Children's Hospital New Orleans, LA, Frontier Science & Technology Research Foundation, Inc., Harvard School of Public Health (HSPH), Jacobi Medical Center, St. Jude Children's Research Hospital, University of Colorado, Denver, University of Miami, Westat

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of HPV vaccine in WLHIV	-3-year cumulative risk of (i) vaccine-hrHPV types that persist 12 months or longer, and (ii) histologic (h) CIN 2+ (CIN 2+ throughout the protocol means "CIN 2 and worse").	3-year