Mother and Daughter HPV Vaccination and Screening Project in Kenya
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)
Run by Indiana University · NCT07240220 · Data updated 2026-11-12
This project tests HPV testing, vaccination, and cervical screening methods in Kenyan women and vaccination for girls, to see if these efforts can reduce cervical cancer risk in the community.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 9 Years to 49 Years |
| Sex | Women only |
| Enrollment | 2500 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Eldoret) |
| Status | Recruiting |
| Started | July 22, 2026 |
| Main results expected | August 1, 2028 |
| Study ends | August 1, 2028 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT07240220 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Kenyan adult women aged 25-49 and girls aged 9-14 whose mothers consent to vaccination, residing in the Webuye region and able to participate in follow-up visits.
✕Probably not a fit
Women who are pregnant or those unable to complete follow-up vaccination doses may receive less direct benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project builds on an existing community program in Webuye, Kenya, to collect data on high-risk HPV testing for detecting premalignant cervical lesions, especially among HIV-infected women. It also aims to identify barriers to participation in prior MDP activities and to evaluate factors associated with immune responses to HPV vaccination in rural Kenyan girls. Interventions include Gardasil-9 vaccination, high-risk HPV DNA testing, Visual Inspection with Acetic Acid (VIA), and potential cervical biopsy. Eligible participants include Kenyan adult women aged 25-49 and girls aged 9-14 whose mothers can consent for vaccination; pregnant individuals are excluded. The study is led by Indiana University with collaboration at Moi University and involves community engagement to facilitate screening and vaccination in a rural setting.
Why it matters
Potential benefit: If successful, the project could improve early detection of precancerous cervical changes and increase HPV vaccination coverage, potentially reducing cervical cancer risk in rural Kenyan communities.
How similar studies have gone: Prior community-based HPV vaccination and self-collection screening approaches in similar settings have shown feasibility and acceptability, though country-level scale-up remains variable.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Moi University
Eldoret, Kenya Recruiting
Study contacts
- Study coordinator: Phillip Tonui, MD
- Email: tonui46@yahoo.co.uk
- Phone: 0722 609132
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing a blood test that looks for HPV-related cancer DNA in women with serious cervical issues to see if it can help detect and monitor these cancers without needing invasive procedures.
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This study is testing a new way to detect endometrial, ovarian, and cervical cancers early by looking for specific DNA markers in the vaginal fluid and blood of women with abnormal bleeding.
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This study is testing which of two surgical methods for treating cervical dysplasia is safer and more effective in removing abnormal cells.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.