Clinical trial · Interventional
The Mother-Daughter Project: Merck-4
The Mother-Daughter Project: Inclusion of Difficult-to-reach Kenyan Families, and Studies of Factors Influencing the Immune Response to HPV Vaccination (Merck-4)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardisil-9 | Biological | — | UNRESOLVED |
| High Risk HPV DNA Testing | Diagnostic Test | — | UNRESOLVED |
| Visual Inspection with acetic acid (VIA) and possible cervical biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Kenyan women
- description
- Up to 500 adult women will undergo cervical cancer screening.
- interventionNames
- Diagnostic Test: High Risk HPV DNA Testing
- Procedure: Visual Inspection with acetic acid (VIA) and possible cervical biopsy
- type
- OTHER
- label
- Kenyan daughters
- description
- Up to an additional 2000 girls (daughters of participants in the Kenyan women arm) will be immunized against HPV using the 9-valent HPV vaccine (Gardasil-9).
- interventionNames
- Biological: Gardisil-9
Primary outcomes (4)
- measure
- Detection of CIN2/3
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Kenyan Adult Women Inclusion Criteria: * ages 25 through 49 years * able/willing to sign informed consent * willing to participate in the community meetings Exclusion Criteria: • pregnant Kenyan Girls Inclusion Criteria: * 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 Exclusion Criteria: • girls who are not willing or unable to return for the second HPV vaccine dose
References
Publications (0)
Data not yet available