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 Gardasil-9, High Risk HPV DNA Testing, or Visual Inspection with acetic acid (VIA) and possible cervical biopsy. The registry lists allocation as randomized. This project serves to continue a community-based initiative, known as the Kenya Mother-Daughter Cervical Cancer Eradication Project, or the Mother-Daughter Project (MDP), in the Webuye region of Western Kenya.
They plan to enroll about 2,500 people at Eldoret. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
The Mother-Daughter Project: Inclusion of Difficult-to-reach Kenyan Families, and Studies of Factors Influencing the Immune Response to HPV Vaccination (Merck-4)
Interventions: Gardasil-9, High Risk HPV DNA Testing, Visual Inspection with acetic acid (VIA) and possible cervical biopsy
Primary outcome (registry wording): Detection of CIN2/3