A Cervical Cancer Prevention Program in Kenya

NCT06411938 | Active Not Recruiting

• 1 other identifier: MISP 101003
• Study Type: interventional
• Target: 2,300
• Locations: 1 country
• Sites: 1

Brief 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 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

Cervical Cancer Prevention; Cervical Cancer

Keywords

Kenya; cervical cancer; prevention

Outcome Measures

Primary Outcomes (2)

• 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+.

  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.

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

Other Outcomes (1)

• HPV detection in genital warts

  Baseline

Study Arms (2)

Kenyan women

OTHER

Up to 300 adult women will undergo cervical cancer screening.

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).

Biological: Gardisil-9

Interventions

High Risk HPV DNA Testing 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).

Kenyan women

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

Gardisil-9 BIOLOGICAL

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.

Also known as: 9-valent HPV vaccine

Kenyan daughters

Eligibility Criteria

• Age: 9 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ages 30 through 55 years
• able/willing to sign informed consent
• able to travel to Webuye clinic for VIA

You may not qualify if:

• unwilling to sign informed consent
• not willing or able to travel to Webuye clinic for VIA
• Kenyan Girls
• ages 9 through 14 years
• willing to sign informed assent for vaccination
• able to return for the second HPV vaccine dose
• 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

Sponsors & Collaborators

• Indiana University: lead
• Academic Model Providing Access to Healthcare (AMPATH): collaborator

Study Sites (1)

Moi University

Eldoret, Kenya

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Watchful Waiting; Acetic Acid

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Acetates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Community-based, non-randomized

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: May 14, 2024
• Study Start: April 2, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 2 years after study completion
• Access Criteria: Upon reasonable request

Locations

KE (1)