Human Papillomavirus (HPV)NCT07576842
C2001P-CS3: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV
A study testing HPV DNA Testing (Abbott Alinity m HPV Assay), Visual Inspection with Acetic Acid and Cervical Histology (Biopsy Procedures) in people with Human Papillomavirus (HPV) and HPV Associated Cancers, run by University of California, San Diego at 1 site in Botswana.
Trial summary
The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Human Papillomavirus (HPV), HPV Associated Cancers, Cervical Cancer
- What is being tested?
- HPV DNA Testing (Abbott Alinity m HPV Assay), Visual Inspection with Acetic Acid and Cervical Histology (Biopsy Procedures)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteBotswana
- Study dates
- 30 Nov 2026to 31 May 2028
- 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection, as documented by:
- any FDA-approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA test kit, and confirmed by Western blot or other approved test), OR
- a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and/or current management of HIV infection, OR
- documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with participant identifiers affixed to the bottles or packages.
- Aged 25 or older.
- Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant.
- Have an intact cervix.
Who cannot join
- Current symptoms or concern for cervical cancer.
- History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer or current symptoms of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer.
- Have undergone cervical hHSIL treatment in the past year.
- Have a history of hysterectomy with removal of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of AIDS and/or genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Botswana1 site
Botswana Harvard Health Partnership
Gaborone, South-East District
Scott L Dryden-Peterson, MD, MSc, 617-732-8881, sldrydenpeterson@bwh.harvard.edu
Scott L Dryden-Peterson, MD, MSc
About this study
Official title: C2001P-CS3 CASCADE: A Feasibility Study of HPV Screening and Management Strategies Utilizing Extended Molecular HPV DNA Genotyping and HPV Viral Load in Women Living With HIV
The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV. While there is consensus that women testing positive for HPV 16 and/or 18 should be immediately managed and treated, optimal management strategies for women with other hrHPV types (non-16/18) are not well defined.
This prospective cohort study will enroll WLWH undergoing cervical cancer screening using primary HPV testing. Women will self-collect vaginal specimens for hrHPV testing using the Abbott Alinity m HPV assay, which provides extended HPV genotyping and a proxy for HPV viral load based on cycle threshold (CT) values. Women with hrHPV detected will return for further evaluation and treatment as indicated. A subset of women will return at Month 6 for repeat evaluation.
The study will evaluate feasibility for a future trial by examining recruitment, retention, return for evaluation, and completion of treatment. It will also explore management strategies for women with non-16/18 hrHPV based on extended genotyping and HPV viral load compared to standard of care approaches using visual inspection with acetic acid (VIA).
- Conditions
- Human Papillomavirus (HPV), HPV Associated Cancers, Cervical Cancer, Human Immunodeficiency Virus (HIV), Cervical Intraepithelial Neoplasia (CIN)
- Being tested
- HPV DNA Testing (Abbott Alinity m HPV Assay), Visual Inspection with Acetic Acid, Cervical Histology (Biopsy Procedures), Cervical Treatment (Thermal Ablation or LEEP/LLETZ)
- Medical subject headings
- Uterine Cervical Neoplasms, Acquired Immunodeficiency Syndrome, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV DNA Testing (Abbott Alinity m HPV Assay)Diagnostic test
Women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. The Alinity m HR HPV assay is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of high-risk HPV DNA. The assay detects 14 hrHPV genotypes by targeting the conserved L1 region of HPV DNA and provides individual or group-level genotyping results, including separate readouts for HPV 16, HPV 18, and HPV 45, and grouped detection of other high-risk types. The assay also provides a proxy for HPV viral load as measured by the cycle threshold (CT) value for the type- or group-specific readout.
Visual Inspection with Acetic AcidProcedure or surgery
Also called VIA
Participants with hrHPV detected will undergo visual inspection with acetic acid (VIA) during a speculum examination. Standard acetic acid (3-5%) is applied to the cervix, and the provider will assess for the presence of cervical lesions, determine suitability for ablative treatment, and characterize the transformation zone (TZ1, TZ2, or TZ3). VIA findings will be used to guide participant management and treatment decisions.
Cervical Histology (Biopsy Procedures)Procedure or surgery
Cervical histology specimens will be obtained from participants with hrHPV detected. Biopsies may include lesion-directed cervical punch biopsies, endo- and ectocervical soft-brush biopsies, or endocervical curettage (ECC). At least two biopsies will be obtained even if no lesions are seen. For participants undergoing LEEP/LLETZ, histology will be obtained through the excisional procedure. Cervical histology will be processed locally and interpreted according to the lower anogenital squamous terminology (LAST), including p16 testing where available to confirm morphologic-appearing CIN 2.
Cervical Treatment (Thermal Ablation or LEEP/LLETZ)Procedure or surgery
Also called Thermal Ablation, LEEP/LLETZ, LEEP, LLETZ
Women with HPV 16 and/or 18 will undergo immediate treatment. Women with non-16/18 hrHPV will undergo immediate treatment if cervical lesions are seen on VIA. Women who are not treated but are subsequently found to have cervical high-grade squamous intraepithelial lesions (hHSIL) on histology will return for cervical treatment. Treatment modality will be determined based on the extent of cervical lesions, with thermal ablation (TA) used for lesions appropriate for ablative therapy and LEEP/LLETZ used for more extensive lesions.
| Study group | Role | What they receive |
|---|---|---|
| Primary HPV screen with management based on HPV types and VIA status | Experimental | All women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. WLWH who test hrHPV negative will exit the study. Women with hrHPV will return for speculum examination, cervical swab collection, VIA, and histology. Women with HPV 16/18 will undergo immediate treatment. Women with non-16/18 hrHPV will undergo immediate treatment only if cervical lesions are seen on VIA. Women who are not treated, but subsequently found to have cervical HSIL on histology, will return for cervical treatment. The choice of treatment modality (TA vs. LEEP/LLETZ) will be determined by the extent of cervical lesions seen on VIA. Women with extensive lesions will undergo LEEP/LLETZ treatment. All women who are enrolled (and therefore hrHPV positive) in the early months of the study will be asked to return for a visit 4-6 months later for repeat HPV testing and cervical histology. Receives: Diagnostic Test: HPV DNA Testing (Abbott Alinity m HPV Assay); Procedure: Visual Inspection with Acetic Acid; Procedure: Cervical Histology (Biopsy Procedures); Procedure: Cervical Treatment (Thermal Ablation or LEEP/LLETZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Potentially Eligible Participants Providing Informed Consent
Number of participants providing informed consent divided by the number approached for consent.
Measured: Screening.
Time to Clinic Receipt of HPV Test Results
Number of days from vaginal sample collection to clinic receipt of HPV test results.
Measured: From sample collection at enrollment to clinic receipt of HPV test results.
Percentage of Participants Receiving HPV Test Results
Percentage of participants who provided a vaginal sample and received their HPV test results.
Measured: Within 6 months of screening.
Proportion of Participants Returning for Baseline Evaluation
Number of participants returning for the baseline evaluation divided by the total number who provided a vaginal self-sample at enrollment.
Measured: From enrollment through baseline.
Proportion of Participants Retained for the Month 6 Visit
Number of participants returning for the Month 6 visit divided by the number who completed the baseline visit more than 6 months before the end of the study.
Measured: From baseline through Month 6.
Proportion of Participants With Cervical HSIL Classified for Treatment
Proportion of participants with hrHPV and histologically-confirmed cervical high-grade squamous intraepithelial lesions (HSIL) classified for treatment under each strategy: visual inspection with acetic acid (VIA), genotype restriction, and genotype restriction plus HPV viral load. The denominator includes estimated HSIL cases among participants who did not return for baseline evaluation. Results are reported separately for each strategy.
Measured: From baseline through Month 6.
Secondary outcomes (5)
hrHPV Prevalence and Genotype Distribution
Proportion of participants with valid HPV results who test positive for any hrHPV, each Abbott Alinity m genotype channel, multiple channels, or hrHPV without HPV 16/18. Results are reported overall and by clinical enrollment unit.
Measured: Screening.
Alternative Abbott Alinity m CT Cutoffs for Detection of Cervical HSIL
Alternative Abbott Alinity m cycle threshold (CT) cutoffs, in PCR cycles, associated with cervical HSIL. Cutoffs are derived using receiver operating characteristic (ROC) analysis and reported by non-16/18 hrHPV channel. Central histology review is used when available.
Measured: Enrollment HPV testing and baseline cervical histology.
Sensitivity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL
Proportion of participants with cervical HSIL classified as positive using alternative CT cutoffs, reported by non-16/18 hrHPV channel among participants positive for that channel with interpretable histology.
Measured: Enrollment HPV testing and baseline cervical histology.
Specificity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL
Proportion of participants without cervical HSIL classified as negative using alternative CT cutoffs, reported by non-16/18 hrHPV channel among participants positive for that channel with interpretable histology.
Measured: Enrollment HPV testing and baseline cervical histology.
Proportion of Participants With Invasive Cervical Cancer or CIN 3 Classified for No Treatment Under Each Management Strategy
Number of participants with CIN 3 or invasive cervical cancer classified for no treatment under each strategy divided by the total number with hrHPV. Strategies include VIA, genotype restriction, and genotype restriction plus HPV viral load. Estimates account for participants who did not return for baseline evaluation.
Measured: From baseline through Month 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus (HPV)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Frontier Science & Technology Research Foundation, Inc., Botswana Harvard Health Partnership, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, H. Lee Moffitt Cancer Center and Research Institute, University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Timothy Wilkin, University of California, San Diego
- Investigators
- Timothy J Wilkin, MD, MPH, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576842
- Sponsor's protocol ID
- 813535
- Other IDs
- UG1CA275414, UG1CA275416, U24CA275417, C2001P-CS3
- Status last verified
- Oct 2026
- First submitted
- 4 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C2001P-CS3 CASCADE: A Feasibility Study of HPV Screening and Management Strategies Utilizing Extended Molecular HPV DNA Genotyping and HPV Viral Load in Women Living With HIV
- ClinicalTrials.gov ID
- NCT07576842
- Acronym / sponsor ID
- 813535
- Conditions
- Human Papillomavirus (HPV), HPV Associated Cancers, Cervical Cancer, Human Immunodeficiency Virus (HIV), Cervical Intraepithelial Neoplasia (CIN)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Frontier Science & Technology Research Foundation, Inc., Botswana Harvard Health Partnership, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center, H. Lee Moffitt Cancer Center and Research Institute, University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 8 May 2026 (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 overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV. While there is consensus that women testing positive for HPV 16 and/or 18 should be immediately managed and treated, optimal management strategies for women with other hrHPV types (non-16/18) are not well defined.
This prospective cohort study will enroll WLWH undergoing cervical cancer screening using primary HPV testing. Women will self-collect vaginal specimens for hrHPV testing using the Abbott Alinity m HPV assay, which provides extended HPV genotyping and a proxy for HPV viral load based on cycle threshold (CT) values. Women with hrHPV detected will return for further evaluation and treatment as indicated. A subset of women will return at Month 6 for repeat evaluation.
The study will evaluate feasibility for a future trial by examining recruitment, retention, return for evaluation, and completion of treatment. It will also explore management strategies for women with non-16/18 hrHPV based on extended genotyping and HPV viral load compared to standard of care approaches using visual inspection with acetic acid (VIA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary HPV screen with management based on HPV types and VIA status | Experimental | Diagnostic Test: HPV DNA Testing (Abbott Alinity m HPV Assay), Procedure: Visual Inspection with Acetic Acid, Procedure: Cervical Histology (Biopsy Procedures), Procedure: Cervical Treatment (Thermal Ablation or LEEP/LLETZ)All women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. WLWH who test hrHPV negative will exit the study. Women with hrHPV will return for speculum examination, cervical swab collection, VIA, and histology. Women with HPV 16/18 will undergo immediate treatment. Women with non-16/18 hrHPV will undergo immediate treatment only if cervical lesions are seen on VIA. Women who are not treated, but subsequently found to have cervical HSIL on histology, will return for cervical treatment. The choice of treatment modality (TA vs. LEEP/LLETZ) will be determined by the extent of cervical lesions seen on VIA. Women with extensive lesions will undergo LEEP/LLETZ treatment. All women who are enrolled (and therefore hrHPV positive) in the early months of the study will be asked to return for a visit 4-6 months later for repeat HPV testing and cervical histology. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-1 infection, as documented by:
- Aged 25 or older.
- Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant.
- Have an intact cervix.
Key exclusion criteria (6 listed)
- Current symptoms or concern for cervical cancer.
- History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer or current symptoms of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer.
- Have undergone cervical hHSIL treatment in the past year.
- Have a history of hysterectomy with removal of the cervix.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of AIDS and/or genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
|---|---|---|
| HPV DNA Testing (Abbott Alinity m HPV Assay)Women will self-collect a vaginal specimen for primary HPV testing to be evaluated on the Abbott Alinity m platform. The Alinity m HR HPV assay is a qualitative, real-time polymerase chain reaction (PCR) assay for the detection of high-risk HPV DNA. The assay detects 14 hrHPV genotypes by targeting the conserved L1 region of HPV DNA and provides individual or group-level genotyping results, including separate readouts for HPV 16, HPV 18, and HPV 45, and grouped detection of other high-risk types. The assay also provides a proxy for HPV viral load as measured by the cycle threshold (CT) value for the type- or group-specific readout. | Diagnostic test | Primary HPV screen with management based on HPV types and VIA status |
| Visual Inspection with Acetic AcidAlso: VIAParticipants with hrHPV detected will undergo visual inspection with acetic acid (VIA) during a speculum examination. Standard acetic acid (3-5%) is applied to the cervix, and the provider will assess for the presence of cervical lesions, determine suitability for ablative treatment, and characterize the transformation zone (TZ1, TZ2, or TZ3). VIA findings will be used to guide participant management and treatment decisions. | Procedure or surgery | Primary HPV screen with management based on HPV types and VIA status |
| Cervical Histology (Biopsy Procedures)Cervical histology specimens will be obtained from participants with hrHPV detected. Biopsies may include lesion-directed cervical punch biopsies, endo- and ectocervical soft-brush biopsies, or endocervical curettage (ECC). At least two biopsies will be obtained even if no lesions are seen. For participants undergoing LEEP/LLETZ, histology will be obtained through the excisional procedure. Cervical histology will be processed locally and interpreted according to the lower anogenital squamous terminology (LAST), including p16 testing where available to confirm morphologic-appearing CIN 2. | Procedure or surgery | Primary HPV screen with management based on HPV types and VIA status |
| Cervical Treatment (Thermal Ablation or LEEP/LLETZ)Also: Thermal Ablation, LEEP/LLETZ, LEEP, LLETZWomen with HPV 16 and/or 18 will undergo immediate treatment. Women with non-16/18 hrHPV will undergo immediate treatment if cervical lesions are seen on VIA. Women who are not treated but are subsequently found to have cervical high-grade squamous intraepithelial lesions (hHSIL) on histology will return for cervical treatment. Treatment modality will be determined based on the extent of cervical lesions, with thermal ablation (TA) used for lesions appropriate for ablative therapy and LEEP/LLETZ used for more extensive lesions. | Procedure or surgery | Primary HPV screen with management based on HPV types and VIA status |
Primary outcome
Proportion of Potentially Eligible Participants Providing Informed Consent
Time frame: Screening.
Number of participants providing informed consent divided by the number approached for consent.
Time to Clinic Receipt of HPV Test Results
Time frame: From sample collection at enrollment to clinic receipt of HPV test results.
Number of days from vaginal sample collection to clinic receipt of HPV test results.
Percentage of Participants Receiving HPV Test Results
Time frame: Within 6 months of screening.
Percentage of participants who provided a vaginal sample and received their HPV test results.
Proportion of Participants Returning for Baseline Evaluation
Time frame: From enrollment through baseline.
Number of participants returning for the baseline evaluation divided by the total number who provided a vaginal self-sample at enrollment.
Proportion of Participants Retained for the Month 6 Visit
Time frame: From baseline through Month 6.
Number of participants returning for the Month 6 visit divided by the number who completed the baseline visit more than 6 months before the end of the study.
Proportion of Participants With Cervical HSIL Classified for Treatment
Time frame: From baseline through Month 6.
Proportion of participants with hrHPV and histologically-confirmed cervical high-grade squamous intraepithelial lesions (HSIL) classified for treatment under each strategy: visual inspection with acetic acid (VIA), genotype restriction, and genotype restriction plus HPV viral load. The denominator includes estimated HSIL cases among participants who did not return for baseline evaluation. Results are reported separately for each strategy.
5 secondary outcomes
hrHPV Prevalence and Genotype Distribution
Time frame: Screening.
Alternative Abbott Alinity m CT Cutoffs for Detection of Cervical HSIL
Time frame: Enrollment HPV testing and baseline cervical histology.
Sensitivity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL
Time frame: Enrollment HPV testing and baseline cervical histology.
Specificity of Alternative Abbott Alinity m CT Cutoffs for Cervical HSIL
Time frame: Enrollment HPV testing and baseline cervical histology.
Proportion of Participants With Invasive Cervical Cancer or CIN 3 Classified for No Treatment Under Each Management Strategy
Time frame: From baseline through Month 6.
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 29 Oct 2026.
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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.
Timothy J Wilkin, MD, MPH study chair
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV DNA Testing (Abbott Alinity m HPV Assay), Visual Inspection with Acetic Acid and Cervical Histology (Biopsy Procedures) in people with Human Papillomavirus (HPV) and HPV Associated Cancers, run by University of California, San Diego at 1 site in Botswana.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Botswana. 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?
Contact Caique Mello, MPH (858-253-6394, camello@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Potentially Eligible Participants Providing Informed Consent (time frame: Screening.). The study lists 6 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 29 Oct 2026.