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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02124252
Date of registration: 24/04/2014
Prospective Registration: Yes
Primary sponsor: Duke University
Public title: Community-Driven Cervical Cancer Prevention in Western Kenya
Scientific title: Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya
Date of first enrolment: January 2016
Target sample size: 7200
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02124252
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Kenya
Contacts
Name:     Megan J Huchko, MD, MPH
Address: 
Telephone:
Email:
Affiliation:  University of California, San Francisco
Key inclusion & exclusion criteria

Inclusion Criteria:

- Female, ages 25-65 Willing to sign informed consent Lives in community where
randomization arm is

Exclusion Criteria:

- Prior hysterectomy



Age minimum: 25 Years
Age maximum: 65 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Human Papilloma Virus Infection
Carcinoma in Situ of Uterine Cervix
Intervention(s)
Behavioral: Community-based testing with standard linkage to care
Behavioral: Community-based HPV testing with enhanced linkage to care
Primary Outcome(s)
Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics [Time Frame: 2 years]
Secondary Outcome(s)
Determine the Efficacy of the cervical cancer prevention program [Time Frame: 4 years]
Secondary ID(s)
Pro00077442
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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