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

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Nov 16, 2023

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

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.