Cervical cancer screening and adherence to follow-up among Hispanic women study protocol: a randomized controlled trial to increase the uptake of cervical cancer screening in Hispanic women

BACKGROUND: In the US, Hispanic women have a higher incidence of, and mortality from, cervical cancer than non-Hispanic white women. The reason for this disparity may be attributable to both low rates of screening and poor adherence to recommended diagnostic follow-up after an abnormal Pap test. The 'Cervical Cancer Screening and Adherence to Follow-up Among Hispanic Women' study is a collaboration between a research institution and community partners made up of members from community based organizations, the Yakima Valley Farm Workers Clinic and the Breast, Cervical, and Colon Health Program of the Yakima District . The study will assess the efficacy of two culturally-appropriate, tailored educational programs designed to increase cervical cancer screening among Hispanic women, based in the Yakima Valley, Washington, US. METHODS/DESIGN: A parallel randomized-controlled trial of 600 Hispanic women aged 21–64, who are non-compliant with Papanicolau (Pap) test screening guidelines. Participants will be randomized using block randomization to (1) a control arm (usual care); (2) a low-intensity information program, consisting of a Spanish-language video that educates women on the importance of cervical cancer screening; or (3) a high-intensity program consisting of the video plus a ‘promotora’ or lay-community health educator-led, home based intervention to encourage cervical cancer screening. Participants who attend cervical cancer screening, and receive a diagnosis of an abnormal Pap test will be assigned to a patient navigator who will provide support and information to promote adherence to follow-up tests, and any necessary surgery or treatment. Primary endpoint: Participants will be tracked via medical record review at community-based clinics, to identify women who have had a Pap test within 7 months of baseline assessment. Medical record reviewers will be blinded to randomization arm. Secondary endpoint: An evaluation of the patient navigator program as a method to improve adherence and reduce time to follow-up among participants who receive an abnormal Pap test result. An additional secondary endpoint is the cost-effectiveness of the two different intensity intervention programs. DISCUSSION: This culturally sensitive intervention aims to increase compliance and adherence to cervical screening in a Hispanic population. If effective, such interventions may reduce incidence of cervical cancer. TRIAL REGISTRATION: NCT01525433