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

NCT05074264 | Active Not Recruiting DMC

• 4 other identifiers: 21622NCI-2020-13805ULACNet-101U54CA242646
• Study Type: interventional
• Target: 1,586
• Locations: 2 countries
• Sites: 4

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.

Conditions

AIDS-Related Anal Carcinoma; AIDS-Related Cervical Carcinoma; High Grade Anal Intraepithelial Neoplasia; High Grade Cervical Intraepithelial Neoplasia; HIV Infection

Outcome Measures

Primary Outcomes (1)

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

  Will assess a screening algorithm with an optimal combination of: point of care high-risk (hr) HPV testing, extended hrHPV genotyping, cytology, progression markers protein E6 and S5 methylation score, to identify cervical and/or anal HSIL or cancer. Different contingency tables will be prepared to describe the statistical relationship between hrHPV infection and HSIL positive status. Using the Bayes Rule, the predicted values will the computed using the prevalence of HSIL positive (overall and per country), where prevalence is the probability of currently being HSIL positive regardless of the duration of time one has the disease. The positive Diagnostic Likelihood Ratios (DLR) and the Negative Diagnostic Likelihood Ratio will be computed to determine the best strategy combining sensitivity and specificity. The 95% confidence intervals of DLR+ will be computed using the log approach.

  Up to 3 years

Study Arms (1)

Imaging, biospecimen collection, anoscopy and/or colposcopy

EXPERIMENTAL

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

Procedure: Biopsy; Procedure: Biospecimen Collection - Anal; Procedure: Biospecimen Collection - Cervical; Procedure: Colposcopy; Procedure: High Resolution Anoscopy; Procedure: Imaging Technique

Interventions

Biopsy PROCEDURE

Undergo biopsy

Imaging, biospecimen collection, anoscopy and/or colposcopy

Biospecimen Collection - Anal PROCEDURE

Undergo collection of anal swabs

Also known as: Biological Sample Collection, Biospecimen Collection

Imaging, biospecimen collection, anoscopy and/or colposcopy

Biospecimen Collection - Cervical PROCEDURE

Undergo collection of cervical swabs

Also known as: Biological Sample Collection, Biospecimen Collection

Imaging, biospecimen collection, anoscopy and/or colposcopy

Colposcopy PROCEDURE

Undergo colposcopy

Imaging, biospecimen collection, anoscopy and/or colposcopy

High Resolution Anoscopy PROCEDURE

Undergo high-resolution anoscopy

Also known as: HRA

Imaging, biospecimen collection, anoscopy and/or colposcopy

Imaging Technique PROCEDURE

Undergo cervical imaging

Also known as: Diagnostic Imaging Technique, Imaging, Imaging Procedures, Medical Imaging

Imaging, biospecimen collection, anoscopy and/or colposcopy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator
• US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet): collaborator

Study Sites (4)

Condesa Specialized Clinic

Mexico City, Mexico City, 06170, Mexico

Location

Condesa Iztapalapa Specialized Clinic

Mexico City, Mexico City, 09730, Mexico

Location

Instituto Nacional de Cancerologia (INCan)

Mexico City, Mexico City, 14080, Mexico

Location

University of Puerto Rico Comprehensive Cancer Center

San Juan, PR, 00936-3027, Puerto Rico

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Biopsy; Colposcopy; X-Rays

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Techniques, Obstetrical and Gynecological; Endoscopy; Minimally Invasive Surgical Procedures; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Joel Palefsky, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: November 30, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); ME (3)