Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH) (NCT06651957) | Clinical Trial Compass
CompletedNot Applicable
Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)
United States, Mexico, Puerto Rico217 participantsStarted 2024-10-31
Plain-language summary
The study evaluates if there is relationship between the kinds of bacteria living in the anus (also known as the anal microbiome) and the risk of human papillomavirus (HPV) infection or HPV-related pre-cancer (high-grade squamous intraepithelial lesions or HSIL) in Hispanic people living with HIV (PLWH) in Puerto Rico, Mexico and California
Who can participate
Age range21 Years
SexALL
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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 1…
What they're measuring
1
Evaluate association between with hr-HPV and pro-inflammatory-mediating taxa
Timeframe: Up to 1 year
2
Association between with hr-HPV and butyrate-producing signatures