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

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Brief Title

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

Official Title

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

Brief 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.
    

Detailed 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.

      OUTLINE: Patients are assigned to 1 of 2 arms.

      ARM 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.

      ARM 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.
    


Study Type

Observational


Primary Outcome

Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL)


Condition

AIDS-Related Anal Carcinoma

Intervention

Biopsy

Study Arms / Comparison Groups

 Arm I (imaging, biospecimen collection, colposcopy)
Description:  Patients undergo collection of cervical images, 3 cervical anal swabs and 3 anal swabs for real-time testing of hrHPV 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 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

3000

Start Date

December 1, 2021

Completion Date

December 31, 2023

Primary Completion Date

December 31, 2023

Eligibility 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 testing for or 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 or within 2 months postpartum
      

Gender

All

Ages

21 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joel Palefsky, MD, (415) 476-8885, [email protected]

Location Countries

Mexico

Location Countries

Mexico

Administrative Informations


NCT ID

NCT05074264

Organization ID

21622

Secondary IDs

NCI-2020-13805

Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Joel Palefsky, MD, Principal Investigator, University of California, San Francisco


Verification Date

October 2021