Hiv, Hpv
Conditions
Keywords
HPV vaccine effectiveness among those living with HIV, Biomarker evaluation for triage of primary HPV cervical cancer screening.
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.
Interventions
DIAGNOSTIC_TESTSelf-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)
Sponsors
University of California, Los Angeles
Frontier Science & Technology Research Foundation, Inc.
Albert Einstein College of Medicine
St. Jude Children's Research Hospital
University of Colorado, Denver
Bronx-Lebanon Hospital Center Health Care System
University of Miami
Baylor College of Medicine
Children's Hospital New Orleans, LA
Jacobi Medical Center
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of HPV vaccine in WLHIV | 3-year | -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"). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnna-Barbara Moscicki, MD
University of California, Los Angeles
STUDY_CHAIRDenise L Jacobson, PhD,MPH
Harvard School of Public Health (HSPH)
STUDY_CHAIRHoward D Strickler, MD, MPH
Albert Einstein College of Medicine
STUDY_CHAIRTzy-Jyun Yao, PhD
Harvard School of Public Health (HSPH)
Outcome results
None listed