Community-Driven Cervical Cancer Prevention in Western Kenya

Duke University

Status: Completed

Conditions: Carcinoma in Situ of Uterine Cervix; Human Papilloma Virus Infection

Treatments: Behavioral: Community-based testing with standard linkage to care; Behavioral: Community-based HPV testing with enhanced linkage to care

Study type: Interventional

Funder types: Other

Identifiers

NCT02124252

Pro00077442

Details and patient eligibility

About

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

Enrollment: 7,200 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Prior hysterectomy

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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7,200 participants in 3 patient groups

Control

No Intervention group

Description:

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).

Standard Intervention

Active Comparator group

Description:

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).

Treatment:

Behavioral: Community-based testing with standard linkage to care

Enhanced Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Community-based HPV testing with enhanced linkage to care