Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico
NCT ID: NCT05074264
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1586 participants
INTERVENTIONAL
2021-11-30
2027-12-31
Brief Summary
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Detailed Description
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I. Evaluate the most efficient algorithm combining point-of-care (POC) HPV-based screening with several triage alternatives: cytology, E6 and/or E7 oncoprotein detection and S5 methylation, to improve the current screening program for detection of anogenital HPV-related cancers and pre-cancers, in men and women living with HIV in Mexico and Puerto Rico.
EXPLORATORY OBJECTIVE:
I. Evaluate artificial intelligence-based algorithms based on cell-phone images of the cervix for their sensitivity, specificity, and negative and positive predictive values for cervical cancers and precancers in women living with HIV in Mexico and Puerto Rico.
II. Evaluate the HPV agreement/concordance between cervicovaginal samples collected by participants and cervical samples collected by clinicians.
OUTLINE: Patients receive standard medical procedures based on anatomy at time of enrollment.
GROUP I (WOMEN LIVING WITH HIV (WLWH)): Patients undergo collection of cervical images, 3 cervical anal swabs and 3 anal swabs for real-time testing of high-risk (hr) HPV over 90 minutes. Patients with a positive hrHPV test on their cervical swab undergo colposcopy and biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for low-grade squamous intraepithelial lesion (LSIL) or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo standard of care (SOC) treatment or enroll in additional studies when they are open to accrual.
GROUP II (MEN LIVING WITH HIV (MLWH)): Patients undergo collection of 3 anal swabs for real-time testing of high-risk HPV over 90 minutes. Patients with a positive hrHPV test undergo high-resolution anoscopy with biopsies of visible lesions. Patients with hrHPV negative test may undergo high-resolution anoscopy. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Imaging, biospecimen collection, anoscopy and/or colposcopy
Patients undergo collection of cervical images (if applicable), 3 cervical anal swabs (if applicable) and 3 anal swabs for real-time testing of HPV or hrHPV over 90 minutes. Patients with a positive HPV or hrHPV test on undergo biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for LSIL or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual
Biopsy
Undergo biopsy
Biospecimen Collection - Anal
Undergo collection of anal swabs
Biospecimen Collection - Cervical
Undergo collection of cervical swabs
Colposcopy
Undergo colposcopy
High Resolution Anoscopy
Undergo high-resolution anoscopy
Imaging Technique
Undergo cervical imaging
Interventions
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Biopsy
Undergo biopsy
Biospecimen Collection - Anal
Undergo collection of anal swabs
Biospecimen Collection - Cervical
Undergo collection of cervical swabs
Colposcopy
Undergo colposcopy
High Resolution Anoscopy
Undergo high-resolution anoscopy
Imaging Technique
Undergo cervical imaging
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
UNKNOWN
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Joel Palefsky, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Condesa Specialized Clinic
Mexico City, Mexico City, Mexico
Condesa Iztapalapa Specialized Clinic
Mexico City, Mexico City, Mexico
Instituto Nacional de Cancerologia (INCan)
Mexico City, Mexico City, Mexico
University of Puerto Rico Comprehensive Cancer Center
San Juan, PR, Puerto Rico
Countries
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Other Identifiers
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NCI-2020-13805
Identifier Type: REGISTRY
Identifier Source: secondary_id
ULACNet-101
Identifier Type: OTHER
Identifier Source: secondary_id
21622
Identifier Type: -
Identifier Source: org_study_id