Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries

NCT06002126 | Active Not Recruiting DMC

• 2 other identifiers: 23-02025683U54CA242639
• Study Type: interventional
• Target: 1,002
• Locations: 2 countries
• Sites: 2

Brief Summary

Cervical cancer is a relatively common cancer among women living with human immunodeficiency virus (HIV). This study will test women for human papillomavirus (HPV) infection of the cervix. The main purpose of this study is to determine the best way to test for damaged areas of the cervix. Damaged areas of the cervix should be treated and removed to prevent cancer of the cervix. Women living with HIV (WLWH) in this study will be seen once, twice or three times in a year. Women will provide several samples related to screening for cervical cancer including a swab of the cervix, a self-collected swab of the vagina and urine. Women will have a detailed examination of the cervix called colposcopy and have a few biopsies, or small pinches of the cervix, to look for areas at risk for turning into cancer. If HPV of the cervix is found but treatment of the cervix is not indicated, women will return in 6 months and in 12 months to repeat these tests. Most women will only need 1 visit. Women found to have damaged areas of the cervix at risk for turning into cancer will be referred for treatment. This protocol will compare different tests to understand the best test to identify women at risk for cervical cancer.

Conditions

Cervix Cancer; HPV Infection; Cervical High Grade Squamous Intraepithelial Lesion; HIV Infections

Keywords

HPV; cervical cancer screening; women with HIV; DNA methylation; extended HPV genotyping

Outcome Measures

Primary Outcomes (1)

• Number of participants with cervical HSIL or invasive cancer on histology at baseline

  Diagnosis of cervical HSIL (defined as CIN 2 with p16 staining, CIN 2-3, or CIN3) or squamous cell carcinoma from histology of cervical biopsies.

  Baseline

Secondary Outcomes (1)

• Number of participants with hrHPV at baseline who are found to have cervical HSIL or invasive cancer on histology at Months 6 or 12.

  Month 6 or Month 12

Study Arms (1)

Cervical cancer screening (single arm)

EXPERIMENTAL

Women will be screened for cervical cancer with HPV testing that provides extended genotyping and DNA quantification. Women will also provide other samples for cervical cancer screening tests. Women will under cervical biopsies.

Diagnostic Test: Xpert HPV; Diagnostic Test: QIAsure Methylation Test

Interventions

Xpert HPV DIAGNOSTIC_TEST

The Cepheid Xpert HPV Assay (Xpert HPV) is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of hrHPV DNA. The assay is formatted in a single-use, Xpert HPV test cartridge and is run on the Cepheid Xpert® System, a multi-analyte, random access, molecular-diagnostic platform ranging in capacity from 1 to 80 test processing modules. Importantly, a single hrHPV DNA test can be completed in one hour, permitting same-day screening and diagnosis (e.g. colposcopy) or treatment (e.g. cryotherapy), reducing the potential for loss to follow-up in lower-resource settings. It uses liquid-based cytologic media and yields five separate results or channels: HPV 16, HPV 18/45, HPV 31/33/35/52/58, HPV 51/59, HPV 39/68/56/66 all with a corresponding cycle threshold.

Cervical cancer screening (single arm)

QIAsure Methylation Test DIAGNOSTIC_TEST

The Qiagen QIAsure assay is a multiplex real-time PCR test that amplifies the methylated promoter regions of the tumor suppressor genes, FAM19A4 and has-mir124-2, as well as a methylation-unspecific fragment of the ACTB reference gene. Hypermethylation of the host genes FAM19A4 and has-mir124-2 has been shown to detect high-grade cervical lesions and cancer.

Cervical cancer screening (single arm)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection, as documented by 1) any FDA approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA, test kit, and confirmed by Western blot or other approved test), OR 2) a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and/or current management of HIV infection, OR 3) documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with two participant identifiers affixed to the bottles or packages.
• Female.
• Aged 25 to 65.
• Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant.

You may not qualify if:

• History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer.
• Have undergone cervical cancer screening in the last 6 months.
• Have undergone cervical HSIL treatment in the past year.
• Have a history of hysterectomy with removal of the cervix.
• Have never had sexual intercourse (oral or genital or anal).
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of Acquired Immunodeficiency Syndrome-AIDS and/or genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study due to the lack of safety data of performing colposcopy during pregnancy.
• Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Cancer Institute (NCI): collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• University of Sao Paulo: collaborator
• Mexican National Institute of Public Health: collaborator
• University of California, San Diego: collaborator
• Instituto Nacional de Salud Publica, Mexico: collaborator

Study Sites (2)

University of São Paulo

São Paulo, 05403-911, Brazil

Location

National Institute of Public Health, Mexico

Cuernavaca, Morelos, 62209, Mexico

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; HIV Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Grant Ellsworth, MD, MS

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: August 2, 2023
• Primary Completion: July 30, 2025
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 3 months post-publication of the primary manuscript through the duration of the NIH award (U54242639).
• Access Criteria: Researchers who provide a methodologically sound proposal for use of the data that is approved by the study investigators and the sponsor. The research must be broadly consistent with that of ULACNet. Researchers may submit a request to the study principal investigator (Grant Ellsworth, gre9006@med.cornell.edu) to request details of request format.

Locations

BR (1); ME (1)