NCT05074264Active, not recruiting
Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV 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
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
This clinical trial aims to find what different tests work best to find high-grade squamous intraepithelial lesions (HSIL) in the cervix or anus in patients living with human immunodeficiency virus (HIV). Patients with HIV are at high risk of becoming infected with human papillomavirus (HPV) in the cervix or anus where it can turn into cancer over several years. HPV causes changes to the cervix and anus, known as HSIL. This means that there is an area of abnormal tissue on the top layers of the cervix or anus. It is considered cervical or anal cancer if the abnormality spreads down into the layers of tissue below the top. If found early, many cases of HSIL can be treated before turning into cancer. Screening for cervical or anal cancer detection or HSIL associated with HPV may result in earlier treatment, if necessary, for patients living with HIV.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1586 (actual)
- First submitted
- 29 Sept 2021
- Start date
- 30 Nov 2021
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV, Cervical cancer
- NCT number
- NCT05074264
What you commit to
- Study type: Interventional
- Participants enrolled: 1586
- From 30 Nov 2021 to the primary completion date, 31 Mar 2026
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Potential participants who received prior treatment of anal, cervical, penile, vaginal, or vulvar lesions within 18 months of study enrollment
Other illness
- History of anal cancer, penile, vulvar, vaginal, or cervical cancer
Age
- 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
Other
- Participants who have undergone hysterectomy
- Inability in the opinion of the study investigator of the participant to comply with study requirements
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Condesa Iztapalapa Specialized Clinic Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Condesa Specialized Clinic Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Instituto Nacional de Cancerología (INCan) Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| University of Puerto Rico, Comprehensive Cancer Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.