Status:
ACTIVE_NOT_RECRUITING
Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Cervix Cancer
HPV Infection
Eligibility:
FEMALE
25-65 years
Phase:
NA
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 pu...
Detailed Description
The overall goal of this research is to develop a point of care hrHPV test and molecular testing that optimizes specificity to detect high-grade squamous intraepithelial lesions (HSIL) (namely cervica...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2027
Estimated Enrollment :
1002 Patients enrolled
Trial Details
Trial ID
NCT06002126
Start Date
August 2 2023
End Date
March 31 2027
Last Update
November 14 2025
Active Locations (2)
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1
University of São Paulo
São Paulo, Brazil, 05403-911
2
National Institute of Public Health, Mexico
Cuernavaca, Morelos, Mexico, 62209