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