Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: HPV DNA Testing (Abbott Alinity m HPV Assay) for Human Papillomavirus (HPV)

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.

Official registry: https://clinicaltrials.gov/study/NCT07925307 · University of California, San Diego · enrollment listed as 750

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are HPV DNA Testing (Abbott Alinity m HPV Assay), Visual Inspection with Acetic Acid, or Cervical Histology (Biopsy Procedures). The registry lists allocation as na. 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.

They plan to enroll about 750 people at Nairobi. Taking part typically means a procedure as part of the study plus check-ins.

Official title (unrewritten)

C2001P-CS6 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

Interventions: HPV DNA Testing (Abbott Alinity m HPV Assay), Visual Inspection with Acetic Acid, Cervical Histology (Biopsy Procedures), Cervical Treatment (Thermal Ablation or LEEP/LLETZ)

Primary outcome (registry wording): Proportion of Potentially Eligible Participants Providing Informed Consent

Who it is for (from inclusion criteria)

  • Ages 25 Years to any
  • Women only
  • 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
  • Have an intact cervix

Public study contact (from the registry)

Caique Mello, MPH

858-253-6394

camello@health.ucsd.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07925307 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07925307?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07925307?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary