Clinical trial NCT06144229: Real-world Effectiveness of HPV Vaccine in Women Living with HIV and Its Impact on Cervical Cancer Screening Accuracies
Official title: Real-world Effectiveness of HPV Vaccine in Women Living with HIV and Its Impact on Cervical Cancer Screening Accuracies (LiVes LLC Study)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hiv
Hpv
Keywords: HPV vaccine effectiveness among those living with HIV
Biomarker evaluation for triage of primary HPV cervical cancer screening.
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
name: Frontier Science & Technology Research Foundation, Inc.
name: Albert Einstein College of Medicine
name: Boston Children's Hospital
name: St. Jude Children's Research Hospital
name: University of Colorado, Denver
name: Bronx-Lebanon Hospital Center Health Care System
name: University of Miami
name: Baylor College of Medicine
name: Children's Hospital New Orleans, LA
name: Jacobi Medical Center
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Westat
First posted: 2023-11-22
Enrollment: 810
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 810 WLHIV greater than or equal to 21 years of age to less than or equal to 40 years of age who are current participants in PHACS (SMARTT, AMP Up, and AMP Up Lite) or HOPE will be tested for hrHPV using a Food and Drug Administration (FDA)-approved primary hrHPV screening test from self-collected specimens.

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.


Eligibility 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.

Primary outcomes:
measure: Effectiveness of HPV vaccine in WLHIV
timeFrame: 3-year
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Miami
country: United States
facility: Univeristy of Miami
state: Florida
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Children's Hospital New Orleans
state: Louisiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center Health Care System
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Memphis
country: United States
facility: St. Jude Children's research hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor college of Medicine
state: Texas
Study officials:
affiliation: University of California, Los Angeles
name: Anna-Barbara Moscicki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Denise L Jacobson, PhD,MPH
role: STUDY_CHAIR
affiliation: Albert Einstein College of Medicine
name: Howard D Strickler, MD, MPH
role: STUDY_CHAIR
affiliation: Harvard School of Public Health (HSPH)
name: Tzy-Jyun Yao, PhD
role: STUDY_CHAIR
References: