ERADICATING CERVICAL CANCER IN KENYA (MISP2)

ERADICATING CERVICAL CANCER IN KENYA: Benefits of Community-based Prevention, and the Effects of Aflatoxin on HPV Vaccination (MISP 60403) (MISP2)

This is a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Human Papilloma Virus
• Intervention / Treatment: Biological: HPV vaccine, Merck

Detailed Description

Cervical cancer is caused by oncogenic HPV, and is the main cause of cancer-related death among Kenyan women. This malignancy is preventable through a combination of screening of adult women 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). Obstacles to screening include travel to clinics, costs, poor specificity 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 costs, delivery infrastructure, lack of education, travel to clinics, and others. In addition, there are few studies of HPV vaccination in African children, and two-dose regimens may not provide adequate protective antibody levels among children chronically exposed to aflatoxin, a potent immunosuppressive agent found in contaminated corn. Investigators propose a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

Objective 1 (Cervical cancer screening): Evaluate High-Risk (HR)-HPV DNA testing of self-collected vaginal swabs as a triage step for VIA among rural Kenyan women.

Hypothesis: All women with negative HR-HPV DNA tests will have normal VIA examinations or falsely-abnormal VIA examinations based on cervical biopsy results. The rationale is that if this hypothesis is correctly proven, it will suggest that VIA is unnecessary for women with negative HR-HPV DNA tests in self-collected vaginal swabs.

Objective 2 (HPV vaccination): Determine the effects of chronic aflatoxin exposure among Kenyan children/adolescents on the likelihood of seroconversion to HPV types represented in the HPV vaccine.

Hypothesis: Compared to children/adolescents without detectable plasma aflatoxin, children/adolescents with evidence of chronic aflatoxin exposure will have a reduced likelihood of seroconversion to HPV types represented in the HPV vaccine. The rationale is that if this hypothesis is correctly proven, it will suggest that adjustments in vaccination doses/schedules may be needed for children with chronic exposure to aflatoxin to assure adequate protection against HPV infection.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Webuye, Kenya
    • Webuye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Kenyan women between ages of 18 and 60 years and children/grandchildren aged 9 through 18 of women attending the Community Meetings.

Exclusion Criteria: Pregnancy, history of cervical cancer, allergy to HPV vaccine (children)

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV vaccination; Children receiving HPV vaccine will be studies for seroconversion to HPV types, and aflatoxin levels in blood will be measured and compared to seroconversion.	Biological: HPV vaccine, Merck; Vaccination against HPV will be offered to 900 children/grandchildren aged 9 through 18 of women attending the Community Meetings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of high-grade cervical intraepithelial neoplasia (CIN) 2/3+	Rate and relative risk of biopsy-proven VIA abnormality between women with positive HR-HPV and women with negative HR-HPV.	Two years
Seroconversion to all HPV vaccine types	Rate and relative risk of seroconversion to all HPV types combined and to each of the nine HPV types represented in the nine-valent HPV vaccine between children with and without plasma aflatoxin detection.	Two years

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Moi University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2021
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HIV; Kenya; HPV
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: 60403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data will be available on request to researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No