The Mother-Daughter Project: Merck-4

NCT ID: NCT07240220

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-08-01

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.

Detailed Description

Cervical cancer is caused by oncogenic, or "high-risk" (HR) human papillomavirus (HPV) and is the main cause of cancer-related death among Kenyan women. Although preventable, this malignancy occurs frequently in women living in rural areas of Kenya where screening is seldom performed, and girls are not vaccinated against HPV. Only 5% of Kenyan women are regularly screened, and 14% have ever been screened, done in Kenya by a method known as Visual Inspection with Acetic Acid (VIA). Obstacles to effective screening include long travel to clinics, high costs, and factors related to VIA such as poor sensitivity and specificity, the need for practitioner training for VIA, variability among providers in VIA interpretation, and others. In addition, while safe and effective HPV vaccines have been available since 2006, very few (<5%) Kenyan girls have been vaccinated. Obstacles to vaccination include high costs, poor delivery infrastructure, lack of education, long travel to clinics, and others. Additionally, strategies based on centralized care have been unsuccessful in preventing cervical cancer in Kenyan women.

In 2018, an initiative known as the Kenya Mother-Daughter Cervical Cancer Eradication Project, or the Mother-Daughter Project (MDP), was developed in the Webuye region of Western Kenya. Early work from the MDP demonstrated that self-collection of cervical swabs, and the administration of HPV vaccination, is acceptable and feasible within a community rural setting. This continuation project will further study the utility of this strategy, elucidate the barriers to participation, and begin to provide information about the impact of the program.

An additional cohort of 500 adult women will be enrolled in the cervical cancer screening initiative to strengthen the power of analysis on HR-HPV testing to detect premalignant lesions of the cervix, especially in HIV-infected women (Aim 1). Second, families who were invited to the MDP but declined to participate will be identified to investigate and identify barriers leading to their non-participation of the MDP (Aim 2). Third, vaccination efforts will be expanded through the enrollment of an additional 2000 girls, and factors associated with the immune response to HPV vaccination among 9- to 14-year-old rural Kenyan girls will be examined (Aim 3).

This prospective cohort study will be conducted in Webuye, a community located in the western region of Kenya, in Bungoma County on the highway to Uganda. A "Community Entry Strategy" was utilized to introduce prior studies and to invite women to community meetings. A female Kenyan Counselor was trained about cervical cancer (including the cause and the ways to prevent the cancer), how to educate women about this malignancy and how to instruct women in performance of self-collected swabs. Village chiefs, village elders, women deemed to be community leaders, and leaders of the local churches have been approached by the Counselor and Study Coordinator to discuss the goals, strategy, and risks and benefits of the study; this process will be repeated before the current study is initiated. Discussions have focused on the importance of early screening for cervical cancer, the use of self-collected swabs for screening, and the importance of vaccination of children against HPV.

For Aim 1, an additional 500 Kenyan women between the ages of 25 to 49 years (the government-recommended age range for screening in Kenya) will be enrolled. Only women who did not participate in our MDP studies will be enrolled. Women will be instructed in collecting vaginal swabs during the community meetings, and these self-collected swabs will be given to the Counselor. Swabs will be tested for HR-HPV DNA at Lancet Laboratories in Nairobi (or at Moi University if reagents can be obtained) using the Roche Cobas Assay. All women will be asked to travel to the Webuye Clinic for pelvic examination and VIA (the Kenyan standard of care). Cervical biopsy will be performed on all HIV-infected women and on those HIV-uninfected women with abnormal VIA examinations. Results will be analyzed to determine the sensitivity, specificity, positive predictive value, and negative predictive value for HR-HPV DNA to predict biopsy-proven cervical intraepithelial lesion grades 2 and 3, or invasive cancer (CIN2/3) in the HIV-infected group of women.

For Aim 2, adult women and their daughters (if they have daughters), will be asked to fill out questionnaires that will provide data about educational aspects and overall acceptability of the MDP and obstacles related to its initiation. This will be done following the second vaccine dose that will be administered to girls at community meetings. Women in the Webuye community have been satisfied with self-collection of swabs as a method of cervical cancer screening, and most are willing to have their daughters vaccination against HPV. However, it is important to identify those women who do not want to attend meetings, do not want to provide self-collected swabs, or do not want their daughters vaccinated against HPV infection. These women will be traced through 1) records that will be acquired for all women who attend the community meeting, 2) records about women who refuse to participate, and 3) meeting in person (home visits) with women who decline through their phone contacts, through community leaders who understand their physical locations.

For Aim 3, an additional 2000 girls, ages 9 through 14, will be enrolled and the first 9v HPV vaccine will be administered to these girls at a community meeting. The second dose of the HPV vaccine will be administered six to twelve months after the first dose at a subsequent community meeting. Factors associated with the immunological response to the 9v HPV vaccine will additionally be studied. For that purpose, 120 girls will have a blood sample taken at a community meeting, approximately 24 months after receiving the second 9v HPV vaccine dose. Each girl's BMI will be determined. The blood sample will be analyzed for plasma aflatoxin, antibody titers to each of the nine HPV types represented in the 9v vaccine, and for folate, iron, and hemoglobin. In addition, girls will be interviewed with their mothers regarding specific dietary habits.

Conditions

Cervical Dysplasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Kenyan women

Up to 500 adult women will undergo cervical cancer screening.

Group Type: OTHER

High Risk HPV DNA Testing

Intervention Type: 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).

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

Intervention Type: 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 daughters

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).

Group Type: OTHER

Gardisil-9

Intervention Type: 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.

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.

Intervention Type: BIOLOGICAL

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).

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: PROCEDURE

Other Intervention Names

9-valent HPV vaccine

Eligibility Criteria

Inclusion Criteria

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

• 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

• pregnant

Kenyan Girls

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Darron Brown MD, MPH

Professor of Microbiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Moi University

Eldoret, , Kenya

Countries

Kenya

Central Contacts

Phillip Tonui, MD

Role: CONTACT

tonui46@yahoo.co.uk

0722 609132

Facility Contacts

Phillip Tonui, MD

Role: primary

tonui46@yahoo.co.uk

0722 609132

Darron R Brown, MD

Role: backup

darbrow@iu.edu

317-407-9034

Other Identifiers

102790

Identifier Type: OTHER

Identifier Source: secondary_id

Merck-4 (irb 28570) (102790)

Identifier Type: -

Identifier Source: org_study_id