Improving cervical cancer screening for women with HIV in Latin America
Optimization of Cervical Cancer Screening Among Women Living With HIV in Latin American Countries
This study is testing better ways to screen for cervical cancer in women with HIV in Latin America by using different tests to see if they can find serious issues more accurately.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | Female |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 2 sites (São Paulo and 1 other locations) |
| Trial ID | NCT06002126 on ClinicalTrials.gov |
What this trial studies
This study aims to optimize cervical cancer screening methods for women living with HIV in Latin America by testing for human papillomavirus (HPV) infections and identifying high-grade lesions. Participants will undergo various tests, including cervical swabs, self-collected vaginal swabs, and urine samples, along with colposcopy and biopsies if necessary. The study will evaluate the effectiveness of a modified HPV test to improve specificity in detecting high-grade squamous intraepithelial lesions (HSIL). A total of 1000 participants aged 25-65 will be enrolled from clinical sites in Mexico and Brazil.
Who should consider this trial
Good fit: Ideal candidates are cisgender women or transgender men aged 25 to 65 who are living with HIV.
Not a fit: Patients with a history of cervical or vulvar cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate cervical cancer screenings and better prevention strategies for women living with HIV.
How similar studies have performed: Other studies have shown promise in optimizing HPV testing for cervical cancer screening, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo and 1 other locations
- University of São Paulo — São Paulo, Brazil (Recruiting)
- National Institute of Public Health, Mexico — Cuernavaca, Morelos, Mexico (Recruiting)
Study contacts
- Principal investigator: Grant Ellsworth, MD, MS — Weill Medical College of Cornell University
- Study coordinator: Caíque Mello, MPH
- Email: cam2358@med.cornell.edu
- Phone: 212-746-7204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.