Community-Driven Cervical Cancer Prevention in Western Kenya

Study Overview
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Brief Summary
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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

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

Conditions
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Human Papilloma Virus Infection, Carcinoma in Situ of Uterine Cervix

Intervention / Treatment
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* Behavioral: Community-based testing with standard linkage to care
* Behavioral: Community-based HPV testing with enhanced linkage to care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female, ages 25-65 Willing to sign informed consent Lives in community where randomization arm is Exclusion Criteria: Prior hysterectomy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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).<br>|
| Active Comparator: Enhanced Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical cancer screening, human papillomavirus testing, Kenya, implementation science