Gut bacteria may hold clues to anal cancer risk in hispanic HIV patients
NCT ID NCT06651957
First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 5 times
Summary
This completed study examined 217 Hispanic people living with HIV in California, Mexico, and Puerto Rico to see if the types of bacteria in the anus are linked to high-risk HPV infection and pre-cancerous lesions. Researchers collected anal swabs and questionnaires to compare microbiomes across the three groups. The goal is to understand why anal cancer rates are higher in some populations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this study could reveal why some Hispanic HIV patients are at higher risk for anal cancer, pointing toward future prevention strategies.
- What could go wrong
- This is an observational study that only looks for patterns, not a treatment trial. Results may not lead to direct medical changes and may not apply to other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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217 people
The number who actually took part.
- Started
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Oct 2024
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Hispanic participants previously consented to ULACNet-101 study diagnosed with HIV and received antiretroviral therapy
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Instituto Nacional de Salud Publica
Cuernavaca, Morelos, 62100, Mexico
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University of California, San Francisco
San Francisco, California, 94143, United States
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University of Puerto Rico
San Juan, 00936, Puerto Rico
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