Examining the link between anal microbiome and HPV risk in Hispanic individuals with HIV
The Relationship Between Anal High-Risk HPV (Hr-HPV) Infection, Anal High-Grade Squamous Intraepithelial Lesions (HSIL), and the Anal Microbiome Among Three Distinct Populations of Hispanic People Living With HIV (PLWH) in California, Mexico and Puerto Rico
This study is trying to see if the bacteria in the anal area affect the risk of HPV infection in Hispanic individuals living with HIV.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 3 sites (San Francisco, California and 2 other locations) |
| Trial ID | NCT06651957 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between anal high-risk HPV infection and the anal microbiome among Hispanic people living with HIV in Mexico, Puerto Rico, and California. Participants will provide three anal swab samples, complete questionnaires, and have their medical records reviewed. Those with visible lesions will undergo high-resolution anoscopy and anal biopsy as part of their usual care. The study aims to enhance understanding of how the anal microbiome may influence HPV infection and related pre-cancerous conditions.
Who should consider this trial
Good fit: Ideal candidates include Hispanic individuals living with HIV who are at risk for anal HPV infection.
Not a fit: Patients who are not Hispanic or do not have HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and prevention strategies for HPV-related cancers in Hispanic populations living with HIV.
How similar studies have performed: While the relationship between the microbiome and HPV is being explored, this specific focus on Hispanic populations living with HIV is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California and 2 other locations
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Instituto Nacional de Salud Publica — Cuernavaca, Morelos, Mexico (Recruiting)
- University of Puerto Rico — San Juan, Puerto Rico (Recruiting)
Study contacts
- Principal investigator: Joel Palefsky, MD — University of California, San Francisco
- Study coordinator: Ross Jamison
- Email: ross.jamison@ucsf.edu
- Phone: 415-476-5884
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.