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

NCT06144229 | Enrolling By Invitation

• 1 other identifier: PH700
• Study Type: observational
• Target: 810
• Locations: 1 country
• Sites: 9

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.

Conditions

Hiv; Hpv

Keywords

HPV vaccine effectiveness among those living with HIV; Biomarker evaluation for triage of primary HPV cervical cancer screening.

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Self-Collection HPV testing kit from Abbott DIAGNOSTIC_TEST

Self-swab collection kits, participates will self-collected vaginal swab for hrHPV test (at home or in the clinic)

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Frontier Science & Technology Research Foundation, Inc.: collaborator
• Albert Einstein College of Medicine: collaborator
• St. Jude Children's Research Hospital: collaborator
• University of Colorado, Denver: collaborator
• Bronx-Lebanon Hospital Center Health Care System: collaborator
• University of Miami: collaborator
• Baylor College of Medicine: collaborator
• Children's Hospital New Orleans, LA: collaborator
• Jacobi Medical Center: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (9)

University of Colorado

Denver, Colorado, 13123, United States

Location

Univeristy of Miami

Miami, Florida, 33136, United States

Location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611-2991, United States

Location

Children's Hospital New Orleans

New Orleans, Louisiana, 70112, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Bronx-Lebanon Hospital Center Health Care System

The Bronx, New York, 10457, United States

Location

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

St. Jude Children's research hospital

Memphis, Tennessee, 38105, United States

Location

Baylor college of Medicine

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cervical vaginal normal saline washes Exfoliated cervical cells

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Papillomavirus Infections

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna-Barbara Moscicki, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Denise L Jacobson, PhD,MPH

  Harvard School of Public Health (HSPH)

  STUDY CHAIR

• Howard D Strickler, MD, MPH

  Albert Einstein College of Medicine

  STUDY CHAIR

• Tzy-Jyun Yao, PhD

  Harvard School of Public Health (HSPH)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 22, 2023
• Study Start: November 12, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)