Merck-3NCT06411938

A Cervical Cancer Prevention Program in Kenya

StatusActive, Not Recruiting

PhaseNot applicable

SponsorIndiana University

Primary completionDec 31, 2026 (estimated)

At risk: Primary completion moved at least 7 months later.

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 6, 2026 Primary completion pushed from May 1, 2026 to Dec 31, 2026 Show 4 more changesShow less
- Eligibility criteria expanded, about 10 words
- Primary endpoints: details revised at 1 of 2 entries
- Study completion pushed from May 1, 2026 to Jul 1, 2027
- Interventions modified
Notable Jan 14, 2026 Primary endpoints: 1 to 2v4 Show 7 more changesShow less
- Eligibility criteria expanded, about 1 word
- Enrollment target: 2500 to 2300
- Interventions: Self-collection of vaginal swabs (Other) to Gardisil-9 (Biological), High Risk HPV DNA Testing (Diagnostic Test), Visual Inspection with acetic acid (VIA) and possible cervical biopsy…
- Study description shortened, about 3,033 words
- Study site revised
- Study arms: 1 to 2
- Secondary endpoints shortened, about 2 words
Minor Aug 14, 2025 Primary and study completion dates: May 2026 to May 1, 2026v3
Minor Oct 14, 2024 Trial status: Not Yet Recruiting to Active, Not Recruiting
- Start date changed from estimate of May 2024 to Apr 2, 2024
- Study title shortened, about 9 words
- Study description expanded, about 5 words
v2
May 8, 2024 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Association between biopsy-proven (CIN2/3+) VIA abnormality and HR-HPV DNA testing

Timeframe: Baseline

Acceptability of the Mother Daughter Program

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

Arms and interventions

Kenyan womenOther

Up to 300 adult women will undergo cervical cancer screening.

Kenyan daughtersOther

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).

Diagnostic tests: High Risk HPV DNA Testing

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

Biologicals: Gardasil-9

Sites

1 site in 1 country

Moi UniversityEldoret, Kenya

About this trial

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.

Trial details

Enrollment: 2,300 participants (estimated)
Started: Apr 2, 2024
Study completion: Jul 1, 2027 (estimated)
Eligibility: 9 to 55, female only, healthy volunteers accepted
Design: Interventional, non-randomized, open label, prevention
Oversight: No data monitoring committee
Conditions: Uterine Cervical Neoplasms, Cervical Cancer Prevention, Cervical Cancer
Collaborators: Academic Model Providing Access to Healthcare (AMPATH)
Official title: A Community-based Cervical Cancer Prevention Program in Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History
First posted: May 14, 2024
Registry updated: Nov 10, 2026
Last verified: Dec 2025

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