ERADICATING CERVICAL CANCER IN KENYA

NCT04774887 | Completed

• 1 other identifier: 60403
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Human Papilloma Virus; HIV Infections

Keywords

HPV; HIV; Kenya

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

HPV vaccination

EXPERIMENTAL

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

Interventions

HPV vaccine, Merck BIOLOGICAL

Vaccination against HPV will be offered to 900 children/grandchildren aged 9 through 18 of women attending the Community Meetings.

HPV vaccination

Eligibility Criteria

• Age: 9 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Moi University: collaborator

Study Sites (1)

Webuye Clinic

Webuye, Kenya

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

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

Model Details: Children of mothers in the study will receive the HPV vaccine as per Kenya guidelines.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: November 13, 2021
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

KE (1)