Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Brazil / NCT06002126
Active, not recruiting Not applicable

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

NCT06002126 · tracked via the Priya Life Science Brazil tracker
Sponsor
Weill Medical College of Cornell University
Phase
Not applicable
Started
2023-08-02
Last updated
2026-06-26

Condition(s) studied

Cervix CancerHPV InfectionCervical High Grade Squamous Intraepithelial LesionHIV Infections

Investigational drug(s) / intervention(s)

Xpert HPVQIAsure Methylation 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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria * 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. Exclusion Criteria * 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University of São Paulo São Paulo São Paulo
National Institute of Public Health, Mexico Cuernavaca Morelos

More Weill Medical College of Cornell University trials in Brazil

Randomization of Single vs Multiple Arterial Grafts Recruiting
Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV Active, not recruiting
Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women Recruiting

Other trials for the same condition

Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals Recruiting
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients Active, not recruiting
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus) Active, not recruiting
Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV Active, not recruiting
Improving Access to PrEP (HIV Prevention Medication) for People in Underserved Areas of Rio de Janeiro Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06002126 on ClinicalTrials.gov ↗ ← All trials in Brazil