About this trial
This study will test the effectiveness of an eHealth promotora (lay health advisor) outreach strategy to increase cervical cancer screening in Hispanic women. The investigators will recruit 160 Hispanic women ages 21-65 who are not up to date with cervical cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on cervical cancer screening outcomes. The study will utilize a two-arm, cluster randomized trial design, and participants will be randomly assigned to the cervical cancer education intervention or a nutrition education control group. The cervical cancer education arm will utilize a promotora to deliver an educational session virtually to encourage cervical cancer screening and receive a resource list for screening sites. The control group will participate in an educational session virtually about the importance of healthy nutrition. The primary study outcome is receipt of cervical cancer screening measured six months following receiving the intervention. The secondary outcomes will include cervical cancer screening knowledge and self-efficacy (confidence to receive cervical cancer screening). The research objective is to test the eHealth promotora intervention effectiveness for promoting cervical cancer screening in an under-screened Hispanic population.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
between the age of 21 and 65 years
identify as Hispanic
not up-to-date with cervical cancer screening [never screened or last Pap test ≥ 3 years - based on U.S. Preventive Services Task Force guidelines]
have no history of cervical cancer
Disqualifiers
under the age of 21 or over the age of 65 years
do not identify as Hispanic
up-to-date with cervical cancer screening [last Pap test < 3 years - based on U.S. Preventive Services Task Force guidelines]
history of cervical cancer
Trial design
Parallel
Treatments tested in this trial
eHealth Promotora
BehavioralIntervention participants attend an eHealth promotora-delivered educational session. Activities include an icebreaker, the completion of a baseline survey, an introduction to cervical cancer using a video and slide presentation, a cervical cancer knowledge pretest/posttest, and a dialogue activity to explore possible barriers and solutions to health care access. Main topics included in the slide presentation are: female anatomy; cervical cancer etiology and disease progression by stage; cancer prevention including diet, exercise, safe sex, cancer screening; human papillomavirus (HPV) vaccine recommendations; Pap test preparations, procedure, screening interval; and information about where to receive a Pap test and seek more information about cervical cancer.
eHealth Healthy Nutrition
BehavioralControl group participants attend an eHealth educational session on healthy nutrition. Activities include an icebreaker, the completion of a baseline survey, an introduction to healthy eating using a video and a slide presentation, a cervical cancer knowledge pretest/posttest, and a dialogue activity to explore benefits and challenges to healthy eating.
Treatment groups
Trial outcomes
Primary outcomes
Cervical cancer screening uptake
Proportion of participants who complete cervical cancer screening determined by cervical cancer screening measure which asks about the last Pap test completed confirmed by chart review if possible.
Secondary outcomes
Cervical cancer screening self-efficacy
The 10-item cervical cancer screening self-efficacy scale is scored on a 5-item Likert scale ranging from 1 (very unsure) to 5 (very sure) (α = 0.88). Questions include asking participants to rate their confidence in having a discussion with their doctor about the Pap test, scheduling and keeping appointments, getting a Pap test despite being worried about pain, and overcoming embarrassment.
Cervical cancer knowledge
A 15-item cervical cancer knowledge instrument measures educational content of the intervention with 10 True/False questions and 5 multiple choice questions to produce a knowledge score ranging from 0 to 15.
Sponsors and contacts
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Florida A&M University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator