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

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

Interventions

DIAGNOSTIC_TEST

Xpert HPV

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.

DIAGNOSTIC_TEST

QIAsure Methylation 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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• H. Lee Moffitt Cancer Center and Research Institute

  collaborator OTHER

• University of Sao Paulo

  collaborator OTHER

• Mexican National Institute of Public Health

  collaborator OTHER_GOV

• University of California, San Diego

  collaborator OTHER

• Instituto Nacional de Salud Publica, Mexico

  collaborator OTHER

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Grant Ellsworth, MD, MS · Weill Medical College of Cornell University

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-02

Primary Completion

2025-07-30

Completion

2027-03-31

Countries

• Brazil
• Mexico

Study Locations