Cervical Cancer PreventionMerck-3NCT06411938
A Cervical Cancer Prevention Program in Kenya
A study testing High Risk HPV DNA Testing, Visual Inspection with acetic acid (VIA) and possible cervical biopsy and Gardisil-9 in people with Cervical Cancer Prevention and Cervical Cancer, run by Indiana University at 1 site in Kenya.
Trial summary
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. This malignancy is theoretically preventable through a combination of screening of adult women and treating those with cervical premalignancies and vaccination of… Read more about this study
- Who is it for?
- Ages 9 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer Prevention, Cervical Cancer
- What is being tested?
- High Risk HPV DNA Testing, Visual Inspection with acetic acid (VIA) and possible cervical biopsy and Gardisil-9
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,300 participants
- Where
- 1 siteKenya
- Study dates
- 2 Apr 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ages 30 through 55 years
- able/willing to sign informed consent
- able to travel to Webuye clinic for VIA
- ages 9 through 14 years
- willing to sign informed assent for vaccination
- able to return for the second HPV vaccine dose
Who cannot join
- unwilling to sign informed consent
- not willing or able to travel to Webuye clinic for VIA
- Kenyan Girls
- girls who are not willing or unable to return for the second HPV vaccine dose
- severe allergic reaction to yeast or a previous dose of the HPV vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-based Cervical Cancer Prevention Program in Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History
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. This malignancy is theoretically preventable through a combination of screening of adult women and treating those with cervical premalignancies and vaccination of children and adolescents against HPV infection. However, only 5% of Kenyan women are regularly screened, and only 14% have ever been screened, which in Kenya is done by a method known as Visual Inspection with Acetic Acid (VIA). Possible obstacles to current screening include long travel to clinics, high costs, poor sensitivity and specificity of VIA, the need for extensive training for VIA, variability among providers in their interpretation of VIA, lack of trained personnel, and others. In addition, while safe and effective HPV vaccines have been available for 15 years, very few (<1%) Kenyan children and adolescents have been vaccinated. Obstacles to vaccination include high costs, poor delivery infrastructure, lack of education, long travel to clinics, and others. The investigators began a community-based program in 2018 to develop a framework for eradication of cervical cancer by screening adult women and vaccinating female children. This program is becoming accepted in the Webuye region of Western Kenya, but there is still a great deal to learn.
Going forward, this initiative will be known as the Kenya Mother-Daughter Cervical Cancer Eradication Program, or the Mother-Daughter Program (MDP) for short. The investigators propose a continuation of the MDP that will allow them to accumulate additional data needed to solidify the overall project and to answer additional questions as described below. To accomplish this goal the investigators will first enroll an additional 300 adult women to the program. This will increase the strength of the analysis of HR-HPV testing in detecting premalignant lesions of the cervix, especially in HIV-infected women. Second, the investigators will identify the positive and negative features of the MDP from the viewpoint of both the adult women and the girls enrolled in the program. Third, because anogenital warts (AGWs) may serve as a reservoir for HR-HPV, especially in women living with HIV/AIDS, the investigators will examine the prevalence, HPV type distribution, and treatment of these lesions among adult women participating in the MDP.
Read the detailed description
Strategies based on centralized care have been unsuccessful in preventing cervical cancer in Kenyan women. HR-HPV DNA testing of self-collected vaginal swabs is acceptable and feasible, and the investigators have now shown that such testing can occur in a community setting in rural Kenya; other groups have demonstrated similar successes in Africa. In studies funded by MISP awards, the investigators have shown that essentially all women invited to community meetings agreed to enroll in the studies, to receive education about cervical cancer, and to provide a self-collected vaginal swab for HR-HPV DNA testing. Nearly all women who attended the community meetings were also willing to have their female children vaccinated against HPV. The investigators have also shown that HPV vaccine can be delivered to western Kenya and can be administered to girls in a community setting. The investigators wish to continue to use this framework in the next MISP to further study the utility of this strategy and to address research questions that will elucidate the barriers to participation and will begin to provide information about the impact of the program.
To accomplish this goal, and an additional 300 adult women will be enrolled into the program. This will increase the strength of the proposed analysis of HR-HPV testing in detecting premalignant lesions of the cervix, especially in HIV-infected women. Second, investigators will identify the positive and negative features of the MDP from the viewpoint of both the adult women and the girls enrolled in the program. Third, because anogenital warts (AGWs) may serve as a reservoir for HR-HPV, especially in women living with HIV/AIDS, investigators will examine the prevalence, HPV type distribution, and treatment of these lesions among adult women participating in the MDP.
Thus these aims build on the infrastructure the investigators have created in the first two MISP award cycles. The investigators believe the MDP, a community based approach to cervical cancer, can become the standard for western Kenya, act as a framework for HPV-associated cancer control, and can lead to a significant improvement in patient care as well as providing an opportunity for hypothesis driven research.
- Conditions
- Cervical Cancer Prevention, Cervical Cancer
- Being tested
- High Risk HPV DNA Testing, Visual Inspection with acetic acid (VIA) and possible cervical biopsy, Gardisil-9
- Keywords
- Kenya, cervical cancer, prevention
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Risk HPV DNA TestingDiagnostic 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 biopsyProcedure or surgery
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.
Gardisil-9Biological
Also called 9-valent HPV vaccine
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.
| Study group | Role | What they receive |
|---|---|---|
| Kenyan women | Other | Up to 300 adult women will undergo cervical cancer screening. Receives: Diagnostic Test: High Risk HPV DNA Testing; Procedure: Visual Inspection with acetic acid (VIA) and possible cervical biopsy |
| Kenyan daughters | Other | Up to 2000 girls (daughters of participants in the Kenyan women arm) will be immunized against HPV using the 9-valent HPV vaccine (Gardasil-9). Receives: Biological: Gardisil-9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between biopsy-proven (CIN2/3+) VIA abnormality and HR-HPV DNA testing
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) at a local clinic. Cervical biopsy will be performed on all women with abnormal VIA examinations, and on 10% of women who have normal VIA exams.
Associations between biopsy-proven VIA abnormality and HR-HPV DNA status will be evaluated to obtain preliminary data for sensitivity and specificity of HR-DNA tests in the detection of biopsy-proven CIN 2/3+.
Measured: Baseline
Acceptability of the Mother Daughter Program
A detailed questionnaire will be used to 1) determine knowledge and beliefs of mothers about HPV and cervical cancer, which will be administered at the beginning of the study and at the end of the study, and 2) capture the opinions of mothers and daughters regarding all aspects of the program. Mothers will be asked about the self-collected swabs, travel to community meetings and the Clinic, and acceptability of HPV vaccination of daughters.
Daughters will be asked to answer questions related to vaccination; how the community-based approach compared to a school-based program, and other questions. Children will fill out the questionnaire with help from their mothers.
The final questionnaire will be administered two weeks after the second HPV vaccine is administered to participating daughters.
Measured: Baseline and after HPV vaccination of daughters is complete (assessed 2 weeks after second vaccine)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start2 Apr 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Community-based, non-randomized
- Masking
- None (open label)
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Model Providing Access to Healthcare (AMPATH)
- Responsible party
- Principal investigator, Darron Brown MD, MPH, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411938
- Sponsor's protocol ID
- MISP 101003
- Acronym
- Merck-3
- Status last verified
- Dec 2025
- First submitted
- 3 Apr 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Cervical Cancer Prevention Program in Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History
- ClinicalTrials.gov ID
- NCT06411938
- Acronym / sponsor ID
- Merck-3 / MISP 101003
- Conditions
- Cervical Cancer Prevention, Cervical Cancer
- Keywords
- Kenya, cervical cancer, prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Academic Model Providing Access to Healthcare (AMPATH)
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This malignancy is theoretically preventable through a combination of screening of adult women and treating those with cervical premalignancies and vaccination of children and adolescents against HPV infection. However, only 5% of Kenyan women are regularly screened, and only 14% have ever been screened, which in Kenya is done by a method known as Visual Inspection with Acetic Acid (VIA). Possible obstacles to current screening include long travel to clinics, high costs, poor sensitivity and specificity of VIA, the need for extensive training for VIA, variability among providers in their interpretation of VIA, lack of trained personnel, and others. In addition, while safe and effective HPV vaccines have been available for 15 years, very few (<1%) Kenyan children and adolescents have been vaccinated. Obstacles to vaccination include high costs, poor delivery infrastructure, lack of education, long travel to clinics, and others. The investigators began a community-based program in 2018 to develop a framework for eradication of cervical cancer by screening adult women and vaccinating female children. This program is becoming accepted in the Webuye region of Western Kenya, but there is still a great deal to learn.
Going forward, this initiative will be known as the Kenya Mother-Daughter Cervical Cancer Eradication Program, or the Mother-Daughter Program (MDP) for short. The investigators propose a continuation of the MDP that will allow them to accumulate additional data needed to solidify the overall project and to answer additional questions as described below. To accomplish this goal the investigators will first enroll an additional 300 adult women to the program. This will increase the strength of the analysis of HR-HPV testing in detecting premalignant lesions of the cervix, especially in HIV-infected women. Second, the investigators will identify the positive and negative features of the MDP from the viewpoint of both the adult women and the girls enrolled in the program. Third, because anogenital warts (AGWs) may serve as a reservoir for HR-HPV, especially in women living with HIV/AIDS, the investigators will examine the prevalence, HPV type distribution, and treatment of these lesions among adult women participating in the MDP.
Detailed description
Strategies based on centralized care have been unsuccessful in preventing cervical cancer in Kenyan women. HR-HPV DNA testing of self-collected vaginal swabs is acceptable and feasible, and the investigators have now shown that such testing can occur in a community setting in rural Kenya; other groups have demonstrated similar successes in Africa. In studies funded by MISP awards, the investigators have shown that essentially all women invited to community meetings agreed to enroll in the studies, to receive education about cervical cancer, and to provide a self-collected vaginal swab for HR-HPV DNA testing. Nearly all women who attended the community meetings were also willing to have their female children vaccinated against HPV. The investigators have also shown that HPV vaccine can be delivered to western Kenya and can be administered to girls in a community setting. The investigators wish to continue to use this framework in the next MISP to further study the utility of this strategy and to address research questions that will elucidate the barriers to participation and will begin to provide information about the impact of the program.
To accomplish this goal, and an additional 300 adult women will be enrolled into the program. This will increase the strength of the proposed analysis of HR-HPV testing in detecting premalignant lesions of the cervix, especially in HIV-infected women. Second, investigators will identify the positive and negative features of the MDP from the viewpoint of both the adult women and the girls enrolled in the program. Third, because anogenital warts (AGWs) may serve as a reservoir for HR-HPV, especially in women living with HIV/AIDS, investigators will examine the prevalence, HPV type distribution, and treatment of these lesions among adult women participating in the MDP.
Thus these aims build on the infrastructure the investigators have created in the first two MISP award cycles. The investigators believe the MDP, a community based approach to cervical cancer, can become the standard for western Kenya, act as a framework for HPV-associated cancer control, and can lead to a significant improvement in patient care as well as providing an opportunity for hypothesis driven research.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Community-based, non-randomized
| Arm | Type | Receives |
|---|---|---|
| Kenyan women | Other | Diagnostic Test: High Risk HPV DNA Testing, Procedure: Visual Inspection with acetic acid (VIA) and possible cervical biopsyUp to 300 adult women will undergo cervical cancer screening. |
| Kenyan daughters | Other | Biological: Gardisil-9Up to 2000 girls (daughters of participants in the Kenyan women arm) will be immunized against HPV using the 9-valent HPV vaccine (Gardasil-9). |
Who may qualify
- Ages
- 9 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- ages 30 through 55 years
- able/willing to sign informed consent
- able to travel to Webuye clinic for VIA
- ages 9 through 14 years
- willing to sign informed assent for vaccination
Key exclusion criteria (5 listed)
- unwilling to sign informed consent
- not willing or able to travel to Webuye clinic for VIA
- Kenyan Girls
- girls who are not willing or unable to return for the second HPV vaccine dose
- severe allergic reaction to yeast or a previous dose of the HPV vaccine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Risk HPV DNA TestingSelf-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). | Diagnostic test | Kenyan women |
| Visual Inspection with acetic acid (VIA) and possible cervical biopsyCervical 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. | Procedure or surgery | Kenyan women |
| Gardisil-9Also: 9-valent HPV vaccineThe 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. | Biological | Kenyan daughters |
Primary outcome
Association between biopsy-proven (CIN2/3+) VIA abnormality and HR-HPV DNA testing
Time frame: Baseline
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) at a local clinic. Cervical biopsy will be performed on all women with abnormal VIA examinations, and on 10% of women who have normal VIA exams. Associations between biopsy-proven VIA abnormality and HR-HPV DNA status will be evaluated to obtain preliminary data for sensitivity and specificity of HR-DNA tests in the detection of biopsy-proven CIN 2/3+.
Acceptability of the Mother Daughter Program
Time frame: Baseline and after HPV vaccination of daughters is complete (assessed 2 weeks after second vaccine)
A detailed questionnaire will be used to 1) determine knowledge and beliefs of mothers about HPV and cervical cancer, which will be administered at the beginning of the study and at the end of the study, and 2) capture the opinions of mothers and daughters regarding all aspects of the program. Mothers will be asked about the self-collected swabs, travel to community meetings and the Clinic, and acceptability of HPV vaccination of daughters. Daughters will be asked to answer questions related to vaccination; how the community-based approach compared to a school-based program, and other questions. Children will fill out the questionnaire with help from their mothers. The final questionnaire will be administered two weeks after the second HPV vaccine is administered to participating daughters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Risk HPV DNA Testing, Visual Inspection with acetic acid (VIA) and possible cervical biopsy and Gardisil-9 in people with Cervical Cancer Prevention and Cervical Cancer, run by Indiana University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between biopsy-proven (CIN2/3+) VIA abnormality and HR-HPV DNA testing (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.