Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico

Last updated: May 5, 2025
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Intraepithelial Neoplasia

Genitourinary Cancer

Aids And Aids Related Infections

Treatment

High Resolution Anoscopy

Biopsy

Imaging Technique

Clinical Study ID

NCT05074264
21622
NCI-2020-13805
U54CA242646
ULACNet-101
  • Ages > 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 careprovider

  • Documentation of receipt of antiretroviral therapy (ART) by a licensed healthcare provider (Documentation may be a record of an ART prescription in theparticipant's medical record, a written prescription in the name of theparticipant for ART, or pill bottles for ART with a label showing theparticipant's name. Receipt of at least two agents is required; each componentagent 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 assaydemonstrating > 1000 RNA copies/mL

  • Any locally licensed HIV screening antibody and/or HIV antibody/antigencombination assay confirmed by a second licensed HIV assay such as a HIV-1Western blot confirmation or HIV rapid multispot antibody differentiation assay

  • NOTE: A "licensed" assay refers to a United States (U.S.) Food and DrugAdministration (FDA)-approved assay or an assay approved by the relevant localhealth 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 riskindividuals such as people living with HIV is recommended for those 25 years of ageor older. Children under the age of 18 are at low risk of developing cervical oranal HSIL/cancer and will not benefit from the kind of screening planned for thisstudy

  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky score >= 70%)

  • Ability to understand and the willingness to sign a written informed consentdocument

Exclusion

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 withstudy requirements

  • Participants who are pregnant (a urine pregnancy test will be provided toparticipants aged 60 years or less) or within 2 months being post-partum

Study Design

Total Participants: 1700
Treatment Group(s): 6
Primary Treatment: High Resolution Anoscopy
Phase:
Study Start date:
November 30, 2021
Estimated Completion Date:
December 31, 2027

Study Description

PRIMARY OBJECTIVE:

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.

Connect with a study center

  • Condesa Specialized Clinic

    Ciudad de México, Cdmx 06170
    Mexico

    Active - Recruiting

  • Instituto Nacional de Cancerologia (INCan)

    Ciudad de México, Cdmx 14080
    Mexico

    Site Not Available

  • Condesa Iztapalapa Specialized Clinic

    Ciudad de mexico, Cdmx 09730
    Mexico

    Active - Recruiting

  • National Institute of Public Health

    Santa María Ahuacatitlán, Cuernavaca, Morelos 62100
    Mexico

    Site Not Available

  • University of Puerto Rico Comprehensive Cancer Center

    San Juan, 00936-3027
    Puerto Rico

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

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