Human Immunodeficiency VirusULACNet-104NCT06651957
Anal High-risk HPV, HSIL, and Microbiome Among Hispanic Peoples Living With HIV (PLWH)
An observational study of Human Immunodeficiency Virus and Human Papillomavirus-Related Anal Squamous Cell Carcinoma, run by University of California, San Francisco at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Human Papillomavirus-Related Anal Squamous Cell Carcinoma, High-Grade Squamous Intraepithelial Lesions
- What is being tested?
- Biospecimen Collection and Questionnaires
- How many people
- 217 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 31 Oct 2024to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hispanic participants previously consented to ULACNet-101 study diagnosed with HIV and received antiretroviral therapy
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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
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
Read the detailed description
PRIMARY OBJECTIVE:
- Study the relationship between anal high-risk HPV (hr-HPV) infection and the anal microbiome among three distinct populations of Hispanic people living with HIV (PLWH) in Mexico, Puerto Rico, and California.
OUTLINE:
This is an observational study.
Participants undergo collection of 3 anal swab samples, complete questionnaires, and have their medical records reviewed on study. Participants with visible lesions undergo high resolution anoscope with anal biopsy per usual care on study.
- Conditions
- Human Immunodeficiency Virus, Human Papillomavirus-Related Anal Squamous Cell Carcinoma, High-Grade Squamous Intraepithelial Lesions
- Being tested
- Biospecimen Collection, Questionnaires
- Keywords
- Microbiome
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionOther
Also called Specimen Collection
Specimen swabs will be obtained.
QuestionnairesOther
Also called Study-related questionnaires
Given to participants
| Study group | Role | What they receive |
|---|---|---|
| Observational | Participants undergo collection of 3 anal swab samples, complete questionnaires, and have their medical records reviewed on study. Participants with visible lesions undergo non-investigational high resolution anoscope with a non-investigational anal biopsy per usual care on study. Receives: Other: Biospecimen Collection; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate association between with hr-HPV and pro-inflammatory-mediating taxa
Among Hispanic PLWH without anal high-grade squamous intraepithelial lesions (HSIL), the investigators hypothesize the microbiome will be different between those with and without hr-HPV infection and the proportion with pro-inflammatory-mediating taxa will be highest among the Puerto Rican population compared with the Mexican and California populations given the higher incidence in anal cancer in Puerto Rico.
Measured: Up to 1 year
Association between with hr-HPV and butyrate-producing signatures
Among Hispanic PLWH with anal hr-HPV at the three locations, the investigators hypothesize the detection of HSIL will be associated with a pro-inflammatory microbiome and a decrease in butyrate-producing signatures, with the proportion of pro-inflammatory changes highest among the Puerto Rican population compared with the Mexican and California populations.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start31 Oct 2024
- Primary completion1 May 2026
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joel Palefsky, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651957
- Sponsor's protocol ID
- 24361
- Other IDs
- NCI-2024-01760, U54CA242646
- Acronym
- ULACNet-104
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with research collaborators
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06651957
- Acronym / sponsor ID
- ULACNet-104 / 24361
- Conditions
- Human Immunodeficiency Virus, Human Papillomavirus-Related Anal Squamous Cell Carcinoma, High-Grade Squamous Intraepithelial Lesions
- Keywords
- Microbiome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVE:
- Study the relationship between anal high-risk HPV (hr-HPV) infection and the anal microbiome among three distinct populations of Hispanic people living with HIV (PLWH) in Mexico, Puerto Rico, and California.
OUTLINE:
This is an observational study.
Participants undergo collection of 3 anal swab samples, complete questionnaires, and have their medical records reviewed on study. Participants with visible lesions undergo high resolution anoscope with anal biopsy per usual care on study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Biospecimen Collection, Other: QuestionnairesParticipants undergo collection of 3 anal swab samples, complete questionnaires, and have their medical records reviewed on study. Participants with visible lesions undergo non-investigational high resolution anoscope with a non-investigational anal biopsy per usual care on study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hispanic participants previously consented to ULACNet-101 study diagnosed with HIV and received antiretroviral therapy
Key inclusion criteria (10 listed)
- Documentation of HIV-1 infection by means of any one of the following:
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Specimen CollectionSpecimen swabs will be obtained. | Other | Observational |
| QuestionnairesAlso: Study-related questionnairesGiven to participants | Other | Observational |
Primary outcome
Evaluate association between with hr-HPV and pro-inflammatory-mediating taxa
Time frame: Up to 1 year
Among Hispanic PLWH without anal high-grade squamous intraepithelial lesions (HSIL), the investigators hypothesize the microbiome will be different between those with and without hr-HPV infection and the proportion with pro-inflammatory-mediating taxa will be highest among the Puerto Rican population compared with the Mexican and California populations given the higher incidence in anal cancer in Puerto Rico.
Association between with hr-HPV and butyrate-producing signatures
Time frame: Up to 1 year
Among Hispanic PLWH with anal hr-HPV at the three locations, the investigators hypothesize the detection of HSIL will be associated with a pro-inflammatory microbiome and a decrease in butyrate-producing signatures, with the proportion of pro-inflammatory changes highest among the Puerto Rican population compared with the Mexican and California populations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with research collaborators
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Palefsky, MD principal investigator
University of California, San Francisco
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Virus and Human Papillomavirus-Related Anal Squamous Cell Carcinoma, run by University of California, San Francisco at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Mexico, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate association between with hr-HPV and pro-inflammatory-mediating taxa (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.