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

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

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection - Anal

Undergo collection of anal swabs

PROCEDURE

Biospecimen Collection - Cervical

Undergo collection of cervical swabs

PROCEDURE

Colposcopy

Undergo colposcopy

PROCEDURE

High Resolution Anoscopy

Undergo high-resolution anoscopy

PROCEDURE

Imaging Technique

Undergo cervical imaging

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)

  collaborator UNKNOWN

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Joel Palefsky, MD · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-30

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Mexico
• Puerto Rico

Study Locations