ERADICATING CERVICAL CANCER IN KENYA (MISP 60403) (MISP2)
Primary Purpose
Human Papilloma Virus, HIV Infections
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HPV vaccine, Merck
Sponsored by
About this trial
This is an interventional prevention trial for Human Papilloma Virus focused on measuring HPV, HIV, Kenya
Eligibility Criteria
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)
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HPV vaccination
Arm Description
Children receiving HPV vaccine will be studies for seroconversion to HPV types, and aflatoxin levels in blood will be measured and compared to seroconversion.
Outcomes
Primary Outcome Measures
Detection of high-grade cervical intraepithelial neoplasia (CIN) 2/3+
We will report the rate and relative risk of biopsy-proven VIA abnormality between women with positive HR-HPV and women with negative HR-HPV.
Seroconversion to all HPV vaccine types
We will report the 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04774887
First Posted
February 24, 2021
Last Updated
February 24, 2021
Sponsor
Indiana University
Collaborators
Moi University
1. Study Identification
Unique Protocol Identification Number
NCT04774887
Brief Title
ERADICATING CERVICAL CANCER IN KENYA (MISP 60403)
Acronym
MISP2
Official Title
ERADICATING CERVICAL CANCER IN KENYA: Benefits of Community-based Prevention, and the Effects of Aflatoxin on HPV Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Moi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
We 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.
Detailed Description
Cervical cancer is caused by oncogenic HPV, and is the main cause of cancer-related death among Kenyan women [1-3]. 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) [3, 4]. 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 [5, 6]. 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. We 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. Our 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. Our 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus, HIV Infections
Keywords
HPV, HIV, Kenya
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Children of mothers in the study will receive the HPV vaccine as per Kenya guidelines.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HPV vaccination
Arm Type
Experimental
Arm Description
Children receiving HPV vaccine will be studies for seroconversion to HPV types, and aflatoxin levels in blood will be measured and compared to seroconversion.
Intervention Type
Biological
Intervention Name(s)
HPV vaccine, Merck
Intervention Description
We will offer vaccination against HPV to 900 children/grandchildren aged 9 through 18 of women attending the Community Meetings.
Primary Outcome Measure Information:
Title
Detection of high-grade cervical intraepithelial neoplasia (CIN) 2/3+
Description
We will report the rate and relative risk of biopsy-proven VIA abnormality between women with positive HR-HPV and women with negative HR-HPV.
Time Frame
Two years
Title
Seroconversion to all HPV vaccine types
Description
We will report the 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.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darron R Brown, MD, MPH
Phone
3174079034
Email
darbrow@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Ermel, MD
Phone
3172748115
Email
aermel@iu.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
De-identified data will be available on request to researchers.
Learn more about this trial
ERADICATING CERVICAL CANCER IN KENYA (MISP 60403)
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