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NCT06144229

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

Enrolling by Invitation
Not specifiedAges 21–40Observational
University of California, Los Angeles
~650 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Self-Collection HPV testing kit from Abbott

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness of HPV vaccine in WLHIV
Measured over 3-year

Conditions

Hiv
Hpv

Explore related trials

Cervical Intraepithelial NeoplasiaHIV InfectionHuman Papillomavirus Infection

Where it's being run

9 sites across 8 states
New York2
Colorado1
Florida1
Illinois1
Louisiana1
Massachusetts1
Tennessee1
Texas1

Study leadership

  • Anna-Barbara Moscicki, MD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
  • Denise L Jacobson, PhD,MPH · STUDY_CHAIR · Harvard School of Public Health (HSPH)
  • Howard D Strickler, MD, MPH · STUDY_CHAIR · Albert Einstein College of Medicine
  • Tzy-Jyun Yao, PhD · STUDY_CHAIR · Harvard School of Public Health (HSPH)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Effectiveness of HPV vaccine in WLHIV3-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").