The Mother-Daughter Project: Merck-4

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age9-49
SponsorIndiana University

About this trial

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. The MDP project, since its initiation in 2018, has sought to develop a framework for the eradication of cervical cancer through effective screening of adult women and through the vaccination of female children.

This project specifically aims to collect additional data on the ability for HR-HPV testing to detect premalignant lesions of the cervix, especially in HIV-infected women, to investigate and identify barriers leading to non-participation in previous MDP efforts, and to examine factors associated with the immune response to HPV vaccination among rural Kenyan girls.

Eligibility criteria

Qualifiers

ages 25 through 49 years

able/willing to sign informed consent

willing to participate in the community meetings

Disqualifiers

ages 9 through 14 years

have mother that is able/willing to sign informed consent for vaccination

can return for the second HPV vaccine dose in 6 - 12 months

Trial design

Treatments tested in this trial

  • Gardisil-9
  • High Risk HPV DNA Testing
  • Visual Inspection with acetic acid (VIA) and possible cervical biopsy

Treatment groups

2,500 Participants
are divided into 2 treatment groups

Sponsors and collaborators