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NCT02124252 Clinical Trial

Community-Driven Cervical Cancer Prevention in Western Kenya

Human Papilloma Virus Infection Clinical Trial

Official title:
Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02124252
Other study ID # Pro00077442
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date March 2019

Study information
Verified date January 2019
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will

Recruitment information / eligibility
Status Completed
Enrollment 7200
Est. completion date March 2019
Est. primary completion date October 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Prior hysterectomy

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Community-based testing with standard linkage to care
Women will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals).
• Community-based HPV testing with enhanced linkage to care
Women will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities.

Locations
Country Name City State
Kenya Kenya Medical Research Institute Nairobi

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

Kenya, 

Outcome
Type Measure Description Time frame Safety issue
Other Determine the cost-effectiveness The investigators will determine the cost-effectiveness of the three strategies in this study: clinic-based testing with standard referral to care, community-health campaign testing w/ standard referral to care & community based testing w/ enhanced linkage to care. 4-5 years
Primary Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics The investigators will compare the number of women who uptake HPV testing in the community health campaign arms compared to the number who uptake HPV testing in the clinic-based arms. 2 years
Secondary Determine the Efficacy of the cervical cancer prevention program The investigators will compare the number of women accessing treatment for positive HPV results with standard linkage to care compared to the enhanced linkage to treatment strategy. 4 years
See also
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Completed NCT00303823 - Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia Phase 2
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Completed NCT04002154 - Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV N/A
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