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Community-Driven Cervical Cancer Prevention in Western Kenya

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ClinicalTrials.gov Identifier: NCT02124252
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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

Condition or disease Intervention/treatment Phase
Human Papilloma Virus Infection Carcinoma in Situ of Uterine Cervix Behavioral: Community-based testing with standard linkage to care Behavioral: Community-based HPV testing with enhanced linkage to care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya
Study Start Date : January 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
No Intervention: Control
Women will be offered HPV testing within the health facilities in the communities randomized to this arm. Women who test HPV positive will be referred to care at the sub-district and district hospitals (current standard of care).
Active Comparator: Standard Intervention
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).
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).

Active Comparator: Enhanced Intervention
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.
Behavioral: 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.




Primary Outcome Measures :
  1. Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Determine the Efficacy of the cervical cancer prevention program [ Time Frame: 4 years ]
    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.


Other Outcome Measures:
  1. Determine the cost-effectiveness [ Time Frame: 4-5 years ]
    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.



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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior hysterectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124252


Locations
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Kenya
Kenya Medical Research Institute
Nairobi, Kenya, 00202
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Megan J Huchko, MD, MPH University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02124252    
Other Study ID Numbers: Pro00077442
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Duke University:
cervical cancer screening
human papillomavirus testing
Kenya
implementation science
Additional relevant MeSH terms:
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Papillomavirus Infections
Uterine Cervical Neoplasms
Papilloma
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Virus Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma
DNA Virus Infections
Tumor Virus Infections