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

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Aug 14, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on improving cervical cancer screening for women living with HIV in Latin America. Cervical cancer is more common in these women, and the study aims to find the best ways to test for early signs of damage in the cervix that could lead to cancer. Participants will undergo various tests, including cervical swabs, self-collected vaginal swabs, and urine samples. They will also have a thorough examination of the cervix and may need small tissue samples, known as biopsies, to check for any risky changes. Depending on the results, women may return for follow-up tests or be referred for treatment if necessary.

To participate in this study, women must be aged between 25 and 65, living with HIV, and able to give informed consent. However, those with a history of certain cancers, recent cervical screenings, or other specific health issues may not be eligible. Most participants will only need to visit the clinic once, but some may need additional visits for follow-up testing. This study is important because it seeks to identify the most effective screening methods to help prevent cervical cancer in a vulnerable population.

Gender

FEMALE

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, enzyme-linked immunoassay-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 antiretrovirals (ARVs) dispensed from an HIV clinical treatment program with two participant identifiers affixed to the bottles or packages.
• • Cisgender women or transgender men.
• • 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.