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

Active Not RecruitingNA

Sponsor: Weill Medical College of Cornell University

Conditions: Cervix Cancer, HPV Infection, Cervical High Grade Squamous Intraepithelial Lesion, HIV Infections

Interventions: Xpert HPV, QIAsure Methylation Test

Countries: Brazil, Mexico

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 overview

Sex: FEMALE

Age: 25 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (2)

São Paulo, São Paulo, Brazil
Cuernavaca, Morelos, Mexico