Human Papilloma Virus Infection Clinical Trial
Official title:
Evaluation of a Community-Driven Cervical Cancer Prevention Strategy in Western Kenya
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 |
Verified date | January 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Kenya Medical Research Institute | Nairobi |
Lead Sponsor | Collaborator |
---|---|
Duke University |
Kenya,
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 |
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