Community-Driven Cervical Cancer Prevention in Western Kenya

Not Applicable

Completed

• Conditions: Human Papilloma Virus Infection; Carcinoma in Situ of Uterine Cervix
• Interventions: Behavioral: Community-based HPV testing with enhanced linkage to care; Behavioral: Community-based testing with standard linkage to care

• Registration Number: NCT02124252
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-24
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Study Start: 2016-01
• Primary Completion: 2016-10
• Status Verified: 2019-01
• Study Completion: 2019-03
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7200

Inclusion Criteria

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

Read More

Exclusion Criteria

• Prior hysterectomy

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Enhanced Intervention	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.
Standard Intervention	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).

Primary Outcome Measures

Name	Time	Method
Reach of cervical cancer screening using self-collected HPV specimens in community health campaigns compared to clinics	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

Name	Time	Method
Determine the Efficacy of the cervical cancer prevention program	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.

Trial Locations

Locations (1)

Kenya Medical Research Institute; 🇰🇪 Nairobi, Kenya