AIDS-Related Anal CarcinomaCAMPO-101NCT05074264
Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People With HIV in Mexico and Puerto Rico
A study testing Biopsy, Biospecimen Collection - Anal and Biospecimen Collection - Cervical in people with AIDS-Related Anal Carcinoma and AIDS-Related Cervical Carcinoma, run by University of California, San Francisco at 4 sites in 2 countries.
Trial summary
This clinical trial aims to find what different tests work best to find high-grade squamous intraepithelial lesions (HSIL) in the cervix or anus in patients living with human immunodeficiency virus (HIV). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma, High Grade Anal Intraepithelial Neoplasia
- What is being tested?
- Biopsy, Biospecimen Collection - Anal and Biospecimen Collection - Cervical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,586 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Nov 2021to 31 Mar 2027
- Phase
- Interventional
- 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
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 ribonucleic acid (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 United States (U.S.) Food and Drug Administration (FDA)-approved assay or an assay approved by the relevant local health authority
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- 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
Who cannot join
- 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 aged 60 years or less) or within 2 months being post-partum
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Mexico3 sites
Condesa Specialized Clinic
Mexico City, Mexico City, 06170
Condesa Iztapalapa Specialized Clinic
Mexico City, Mexico City, 09730
Instituto Nacional de Cancerologia (INCan)
Mexico City, Mexico City, 14080
Puerto Rico1 site
University of Puerto Rico Comprehensive Cancer Center
San Juan, PR, 00936-3027
About this study
Official title: Optimization of Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People Living With HIV in Mexico and Puerto Rico
This clinical trial aims to find what different tests work best to find high-grade squamous intraepithelial lesions (HSIL) in the cervix or anus in patients living with human immunodeficiency virus (HIV). Patients with HIV are at high risk of becoming infected with human papillomavirus (HPV) in the cervix or anus where it can turn into cancer over several years. HPV causes changes to the cervix and anus, known as HSIL. This means that there is an area of abnormal tissue on the top layers of the cervix or anus. It is considered cervical or anal cancer if the abnormality spreads down into the layers of tissue below the top. If found early, many cases of HSIL can be treated before turning into cancer. Screening for cervical or anal cancer detection or HSIL associated with HPV may result in earlier treatment, if necessary, for patients living with HIV.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the most efficient algorithm combining point-of-care (POC) HPV-based screening with several triage alternatives: cytology, E6 and/or E7 oncoprotein detection and S5 methylation, to improve the current screening program for detection of anogenital HPV-related cancers and pre-cancers, in men and women living with HIV in Mexico and Puerto Rico.
EXPLORATORY OBJECTIVE:
- Evaluate artificial intelligence-based algorithms based on cell-phone images of the cervix for their sensitivity, specificity, and negative and positive predictive values for cervical cancers and precancers in women living with HIV in Mexico and Puerto Rico.
II. Evaluate the HPV agreement/concordance between cervicovaginal samples collected by participants and cervical samples collected by clinicians.
OUTLINE: Patients receive standard medical procedures based on anatomy at time of enrollment.
GROUP I (WOMEN LIVING WITH HIV (WLWH)): Patients undergo collection of cervical images, 3 cervical anal swabs and 3 anal swabs for real-time testing of high-risk (hr) HPV over 90 minutes. Patients with a positive hrHPV test on their cervical swab undergo colposcopy and biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for low-grade squamous intraepithelial lesion (LSIL) or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo standard of care (SOC) treatment or enroll in additional studies when they are open to accrual.
GROUP II (MEN LIVING WITH HIV (MLWH)): Patients undergo collection of 3 anal swabs for real-time testing of high-risk HPV over 90 minutes. Patients with a positive hrHPV test undergo high-resolution anoscopy with biopsies of visible lesions. Patients with hrHPV negative test may undergo high-resolution anoscopy. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual.
- Conditions
- AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma, High Grade Anal Intraepithelial Neoplasia, High Grade Cervical Intraepithelial Neoplasia, HIV Infection
- Being tested
- Biopsy, Biospecimen Collection - Anal, Biospecimen Collection - Cervical, Colposcopy, High Resolution Anoscopy
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Undergo biopsy
Biospecimen Collection - AnalProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collection
Undergo collection of anal swabs
Biospecimen Collection - CervicalProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collection
Undergo collection of cervical swabs
ColposcopyProcedure or surgery
Undergo colposcopy
High Resolution AnoscopyProcedure or surgery
Also called HRA
Undergo high-resolution anoscopy
Imaging TechniqueProcedure or surgery
Also called Diagnostic Imaging Technique, Imaging, Imaging Procedures, Medical Imaging
Undergo cervical imaging
| Study group | Role | What they receive |
|---|---|---|
| Imaging, biospecimen collection, anoscopy and/or colposcopy | Experimental | Patients undergo collection of cervical images (if applicable), 3 cervical anal swabs (if applicable) and 3 anal swabs for real-time testing of HPV or hrHPV over 90 minutes. Patients with a positive HPV or hrHPV test on undergo biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for LSIL or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual Receives: Procedure: Biopsy; Procedure: Biospecimen Collection - Anal; Procedure: Biospecimen Collection - Cervical; Procedure: Colposcopy; Procedure: High Resolution Anoscopy; Procedure: Imaging Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL)
Will assess a screening algorithm with an optimal combination of: point of care high-risk (hr) HPV testing, extended hrHPV genotyping, cytology, progression markers protein E6 and S5 methylation score, to identify cervical and/or anal HSIL or cancer. Different contingency tables will be prepared to describe the statistical relationship between hrHPV infection and HSIL positive status. Using the Bayes Rule, the predicted values will the computed using the prevalence of HSIL positive (overall and per country), where prevalence is the probability of currently being HSIL positive regardless of the duration of time one has the disease. The positive Diagnostic Likelihood Ratios (DLR) and the Negative Diagnostic Likelihood Ratio will be computed to determine the best strategy combining sensitivity and specificity. The 95% confidence intervals of DLR+ will be computed using the log approach.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start30 Nov 2021
- Primary completion31 Mar 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS-Related Anal CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
- Responsible party
- Sponsor
- Investigators
- Joel Palefsky, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074264
- Sponsor's protocol ID
- 21622
- Other IDs
- NCI-2020-13805, ULACNet-101, U54CA242646
- Acronym
- CAMPO-101
- Status last verified
- Aug 2026
- First submitted
- 29 Sep 2021
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Screening Algorithms for Cervical and Anal High-Grade Squamous Intraepithelial Lesions in People Living With HIV in Mexico and Puerto Rico
- ClinicalTrials.gov ID
- NCT05074264
- Acronym / sponsor ID
- CAMPO-101 / 21622
- Conditions
- AIDS-Related Anal Carcinoma, AIDS-Related Cervical Carcinoma, High Grade Anal Intraepithelial Neoplasia, High Grade Cervical Intraepithelial Neoplasia, HIV Infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,586 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Oct 2021 (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.
This clinical trial aims to find what different tests work best to find high-grade squamous intraepithelial lesions (HSIL) in the cervix or anus in patients living with human immunodeficiency virus (HIV). Patients with HIV are at high risk of becoming infected with human papillomavirus (HPV) in the cervix or anus where it can turn into cancer over several years. HPV causes changes to the cervix and anus, known as HSIL. This means that there is an area of abnormal tissue on the top layers of the cervix or anus. It is considered cervical or anal cancer if the abnormality spreads down into the layers of tissue below the top. If found early, many cases of HSIL can be treated before turning into cancer. Screening for cervical or anal cancer detection or HSIL associated with HPV may result in earlier treatment, if necessary, for patients living with HIV.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the most efficient algorithm combining point-of-care (POC) HPV-based screening with several triage alternatives: cytology, E6 and/or E7 oncoprotein detection and S5 methylation, to improve the current screening program for detection of anogenital HPV-related cancers and pre-cancers, in men and women living with HIV in Mexico and Puerto Rico.
EXPLORATORY OBJECTIVE:
- Evaluate artificial intelligence-based algorithms based on cell-phone images of the cervix for their sensitivity, specificity, and negative and positive predictive values for cervical cancers and precancers in women living with HIV in Mexico and Puerto Rico.
II. Evaluate the HPV agreement/concordance between cervicovaginal samples collected by participants and cervical samples collected by clinicians.
OUTLINE: Patients receive standard medical procedures based on anatomy at time of enrollment.
GROUP I (WOMEN LIVING WITH HIV (WLWH)): Patients undergo collection of cervical images, 3 cervical anal swabs and 3 anal swabs for real-time testing of high-risk (hr) HPV over 90 minutes. Patients with a positive hrHPV test on their cervical swab undergo colposcopy and biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for low-grade squamous intraepithelial lesion (LSIL) or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo standard of care (SOC) treatment or enroll in additional studies when they are open to accrual.
GROUP II (MEN LIVING WITH HIV (MLWH)): Patients undergo collection of 3 anal swabs for real-time testing of high-risk HPV over 90 minutes. Patients with a positive hrHPV test undergo high-resolution anoscopy with biopsies of visible lesions. Patients with hrHPV negative test may undergo high-resolution anoscopy. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging, biospecimen collection, anoscopy and/or colposcopy | Experimental | Procedure: Biopsy, Procedure: Biospecimen Collection - Anal, Procedure: Biospecimen Collection - Cervical, Procedure: Colposcopy, Procedure: High Resolution Anoscopy, Procedure: Imaging TechniquePatients undergo collection of cervical images (if applicable), 3 cervical anal swabs (if applicable) and 3 anal swabs for real-time testing of HPV or hrHPV over 90 minutes. Patients with a positive HPV or hrHPV test on undergo biopsies of visible lesions. Patients with a negative hrHPV test on their cervical swab may undergo a colposcopy. Patients with a positive hrHPV test on their anal swab undergo high-resolution anoscopy at a later visit within 1 month. Patients with a negative hrHPV on their anal swabs may undergo a high-resolution anoscopy and biopsies of visible lesions, and those with a positive anal cytology for LSIL or worse undergo a high-resolution anoscopy and biopsies within 1 month. Patients may be given a diagnosis and treatment at the second visit. Patients diagnosed with HSIL may undergo SOC treatment or enroll in additional studies when they are open to accrual |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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
Key exclusion criteria (5 listed)
- 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 aged 60 years or less) or within 2 months being post-partum
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 |
|---|---|---|
| BiopsyUndergo biopsy | Procedure or surgery | Imaging, biospecimen collection, anoscopy and/or colposcopy |
| Biospecimen Collection - AnalAlso: Biological Sample Collection, Biospecimen CollectionUndergo collection of anal swabs | Procedure or surgery | Imaging, biospecimen collection, anoscopy and/or colposcopy |
| Biospecimen Collection - CervicalAlso: Biological Sample Collection, Biospecimen CollectionUndergo collection of cervical swabs | Procedure or surgery | Imaging, biospecimen collection, anoscopy and/or colposcopy |
| ColposcopyUndergo colposcopy | Procedure or surgery | Imaging, biospecimen collection, anoscopy and/or colposcopy |
| High Resolution AnoscopyAlso: HRAUndergo high-resolution anoscopy | Procedure or surgery | Imaging, biospecimen collection, anoscopy and/or colposcopy |
| Imaging TechniqueAlso: Diagnostic Imaging Technique, Imaging, Imaging Procedures, Medical ImagingUndergo cervical imaging | Procedure or surgery | Imaging, biospecimen collection, anoscopy and/or colposcopy |
Primary outcome
Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL)
Time frame: Up to 3 years
Will assess a screening algorithm with an optimal combination of: point of care high-risk (hr) HPV testing, extended hrHPV genotyping, cytology, progression markers protein E6 and S5 methylation score, to identify cervical and/or anal HSIL or cancer. Different contingency tables will be prepared to describe the statistical relationship between hrHPV infection and HSIL positive status. Using the Bayes Rule, the predicted values will the computed using the prevalence of HSIL positive (overall and per country), where prevalence is the probability of currently being HSIL positive regardless of the duration of time one has the disease. The positive Diagnostic Likelihood Ratios (DLR) and the Negative Diagnostic Likelihood Ratio will be computed to determine the best strategy combining sensitivity and specificity. The 95% confidence intervals of DLR+ will be computed using the log approach.
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 24 Aug 2026.
- Individual participant dataSharing planned: No
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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
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Biospecimen Collection - Anal and Biospecimen Collection - Cervical in people with AIDS-Related Anal Carcinoma and AIDS-Related Cervical Carcinoma, run by University of California, San Francisco at 4 sites in 2 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 9 inclusion and 5 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 24 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 4 sites in 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?
Most efficient algorithm for detection of anogenital human papillomavirus (HPV)-related cancers and high-grade squamous intraepithelial lesions (HSIL) (time frame: Up to 3 years). 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 24 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.