Clinical trial · Interventional
A Cervical Cancer Prevention Program in Kenya
A Community-based Cervical Cancer Prevention Program in Kenya: Overcoming Obstacles to Care, Promoting Understanding of HPV Natural History
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer Prevention | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gardisil-9 | Biological | — | UNRESOLVED |
| High Risk HPV DNA Testing | Diagnostic Test | — | UNRESOLVED |
| Visual Inspection with acetic acid (VIA) and possible cervical biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Kenyan women
- description
- Up to 300 adult women will undergo cervical cancer screening.
- interventionNames
- Diagnostic Test: High Risk HPV DNA Testing
- Procedure: Visual Inspection with acetic acid (VIA) and possible cervical biopsy
- type
- OTHER
- label
- Kenyan daughters
- description
- 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).
- interventionNames
- Biological: Gardisil-9
Primary outcomes (2)
- measure
- Association between biopsy-proven (CIN2/3+) VIA abnormality and HR-HPV DNA testing
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Kenyan Adult Women Inclusion Criteria: * ages 30 through 55 years * able/willing to sign informed consent * able to travel to Webuye clinic for VIA Exclusion Criteria: * unwilling to sign informed consent * not willing or able to travel to Webuye clinic for VIA Kenyan Girls Inclusion Criteria: * ages 9 through 14 years * willing to sign informed assent for vaccination * able to return for the second HPV vaccine dose Exclusion Criteria: * 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
References
Publications (0)
Data not yet available