Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-24 @ 7:01 PM
NCT ID:
NCT06651957
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 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 U.S. 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.
* Previous consent to participate in ULACNet-101 in Mexico and Puerto Rico sites or a patient at Anal Neoplasia Clinic, Research and Education (ANCRE) Center in San Francisco.
Exclusion Criteria:
* History of inflammatory bowel disease or colorectal cancer
* Participants with active evidence of proctitis.
* Participants on immunosuppressive drugs. Exclusion criteria from ULACNet-101
* 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 of age 60 years or less) or within 2 months postpartum.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06651957
Study Brief:
Protocol Section:
NCT06651957