The Mother-Daughter Project: Merck-4

NCT07240220 | Not Yet Recruiting

• 2 other identifiers: Merck-4 (irb 28570) (102790)102790
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Dysplasia

Keywords

cervical dysplasia; cervical cancer screening; HPV infection

Outcome Measures

Primary Outcomes (4)

• Detection of CIN2/3

  Following a community meeting at which education on cervical cancer, self-collection of swabs for analysis and HPV vaccination are discussed, participating adult women will provide a self collected swab that will be analyzed for high risk HPV. All participating adult women will additionally undergo pelvic examination and VIA (the Kenyan standard of care). Cervical biopsy will be performed on all HIV-infected women and those HIV-uninfected women with abnormal VIA examinations. For the cohort of women who will undergo cervical biopsy, the rates of HR-HPV positivity, VIA abnormality and CIN2/3 detection will be reported for all women and by HIV status. Sensitivity, specificity, positive predictive value, and negative predictive value between HR-HPV and VIA in the detection of biopsy-proven cervical intraepithelial lesion grades 2 and 3, or invasive cancer (CIN2/3) will be compared.

  Baseline

• Local knowledge and attitudes

  Adult women and their daughters (if they have daughters), will be asked to fill out questionnaires that will evaluate women's knowledge of cervical cancer screening and HPV vaccination and attitudes towards their own health and health of their daughters.

  Baseline and after HPV vaccination of daughters is complete (assessed 2 weeks after second vaccine)

• Barriers to participation

  Both women who attend the MDP community meeting but decline to participate, and women in the village who were invited but did not attend the community meeting can be identified by the local counselor. The counselor will later contact these women for an interview to determine the reasons for declining participation. It is expected that 20 non-participants will be interviewed to identify barriers. Specific barriers mentioned by the women will then be grouped into several categories. Potential categories may be "lack of confidence in safety of the procedures" (self-collection swab or HPV vaccination of children), "other obligations competing for time", or "cultural-related inhibition". The frequency and percentage of each specific barrier mentioned by the women will be reported.

  During a one-time interview

• Factors that influence immunity to the HPV vaccine

  The HPV vaccine will be administered at community meetings to participating girls. Approximately 24 months after receiving the second vaccine dose, a subset of girls will undergo a blood sample and BMI measurement at another community meeting. The blood sample will be analyzed for plasma aflatoxin, for antibody titers to each of the nine HPV types in the vaccine, and for folate, iron, and hemoglobin (indicators of nutrition). The girls will also be interviewed with their mothers regarding specific dietary habits.

  24 months after second HPV vaccine

Study Arms (2)

Kenyan women

OTHER

Up to 500 adult women will undergo cervical cancer screening.

Diagnostic Test: High Risk HPV DNA Testing; Procedure: Visual Inspection with acetic acid (VIA) and possible cervical biopsy

Kenyan daughters

OTHER

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).

Biological: Gardisil-9

Interventions

Gardisil-9 BIOLOGICAL

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.

Also known as: 9-valent HPV vaccine

Kenyan daughters

High Risk HPV DNA Testing DIAGNOSTIC_TEST

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).

Kenyan women

Visual Inspection with acetic acid (VIA) and possible cervical biopsy PROCEDURE

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.

Kenyan women

Eligibility Criteria

• Age: 9 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ages 25 through 49 years
• able/willing to sign informed consent
• willing to participate in the community meetings

You may not qualify if:

• pregnant
• Kenyan Girls
• 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
• girls who are not willing or unable to return for the second HPV vaccine dose

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Moi University

Eldoret, Kenya

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Papillomavirus Infections

Interventions

Watchful Waiting; Acetic Acid

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Central Study Contacts

Phillip Tonui, MD

CONTACT

0722 609132; tonui46@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Microbiology

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2025-11

Locations

KE (1)