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The Mother-Daughter Project: Merck-4
Sponsor: Indiana University
Summary
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.
Official title: The Mother-Daughter Project: Inclusion of Difficult-to-reach Kenyan Families, and Studies of Factors Influencing the Immune Response to HPV Vaccination (Merck-4)
Key Details
Gender
FEMALE
Age Range
9 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
2500
Start Date
2026-02-01
Completion Date
2028-08-01
Last Updated
2026-01-15
Healthy Volunteers
Yes
Conditions
Interventions
Gardisil-9
The 9 valent vaccine will be offfered to 2000 adolescent girls. The 9 valent vaccine will be offered to 2000 adolescent girls. The first vaccination dose will be administered at a community meeting, after parental consent has been obtained. The second vaccination dose will be administered at a subsequent community meeting, 6 to 12 months after the first dose.
High Risk HPV DNA Testing
Self-collected cervical swabs will be tested for high-risk HPV using the Roche Cobas Assay. This assay provides specific HPV 16 or 18 detection, as well as detection of any of 12 additional oncogenic types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).
Visual Inspection with acetic acid (VIA) and possible cervical biopsy
Cervical screening in Kenya is usually done through pelvic examination and VIA. Cervical biopsy will additionally be performed for all HIV-infected women, and for HIV-uninfected women with abnormal VIA results.
Locations (1)
Moi University
Eldoret, Kenya