Screening for high-grade lesions in HIV patients in Mexico and Puerto Rico
Optimization of Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People Living With HIV in Mexico and Puerto Rico
This study is testing new ways to screen for serious cervical and anal lesions in people with HIV in Mexico and Puerto Rico to help catch potential cancers earlier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1700 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 4 sites (Ciudad de mexico, Cdmx and 3 other locations) |
| Trial ID | NCT05074264 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of various screening algorithms to detect high-grade squamous intraepithelial lesions (HSIL) in the cervix and anus of individuals living with HIV. The study combines point-of-care HPV testing with triage methods such as cytology and artificial intelligence-based image analysis to improve early detection of HPV-related cancers. Participants will undergo a series of tests, including biopsies and high-resolution anoscopy, to assess the presence of HSIL and facilitate timely treatment. The trial aims to enhance current screening programs and ultimately reduce cancer incidence in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals living with HIV, particularly women, who are at risk for HPV-related cervical and anal lesions.
Not a fit: Patients who are not living with HIV or those who do not have a documented history of high-risk HPV infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and treatment of precancerous lesions in HIV patients, potentially reducing the risk of developing cervical and anal cancers.
How similar studies have performed: Other studies have shown promise in using similar screening approaches for HPV-related cancers, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documentation of HIV-1 infection by means of any one of the following: * Documentation of HIV diagnosis in the medical record by a licensed health care provider * Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone \[e.g., Truvada\], which is exclusionary); * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \> 1000 RNA copies/mL * Any locally licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay * NOTE: A "licensed" assay refers to a United States (U.S.) Food and Drug Administration (FDA)-approved assay or an assay approved by the relevant local health authority * Age 21 years or older. Cervical HSIL/cancer screening does not usually begin until 20 years of age or older. Also, anal HSIL/cancer screening among high risk individuals such as people living with HIV is recommended for those 25 years of age or older. Children under the age of 18 are at low risk of developing cervical or anal HSIL/cancer and will not benefit from the kind of screening planned for this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky score \>= 70%) * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants who have undergone hysterectomy * History of anal cancer, penile, vulvar, vaginal, or cervical cancer * Potential participants who received prior treatment of anal, cervical, penile, vaginal, or vulvar lesions within 18 months of study enrollment * Inability in the opinion of the study investigator of the participant to comply with study requirements * Participants who are pregnant (a urine pregnancy test will be provided to participants aged 60 years or less) or within 2 months being post-partum
Where this trial is running
Ciudad de mexico, Cdmx and 3 other locations
- Condesa Iztapalapa Specialized Clinic — Ciudad de mexico, Cdmx, Mexico (Recruiting)
- Condesa Specialized Clinic — Ciudad de México, Cdmx, Mexico (Recruiting)
- Instituto Nacional de Cancerologia (INCan) — Ciudad de México, Cdmx, Mexico (Not_yet_recruiting)
- University of Puerto Rico Comprehensive Cancer Center — San Juan, Puerto Rico (Recruiting)
Study contacts
- Principal investigator: Joel Palefsky, MD — University of California, San Francisco
- Study coordinator: Joel Palefsky, MD
- Email: Joel.Palefsky@ucsf.edu
- Phone: (415) 476-8885
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.