Effectiveness of an EHealth Intervention for Uptake of Cervical Cancer Screening in Hispanic Women

Обзор

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.

Вмешательства

• Поведенческое eHealth Promotora
  Intervention 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 p
• Поведенческое eHealth Healthy Nutrition
  Control 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.

Первичные конечные точки

• Cervical cancer screening uptake [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Cervical cancer screening self-efficacy [Срок оценки: 6 months]
• Cervical cancer knowledge [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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
• have not had a hysterectomy.

Критерии исключения

• 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
• have had a hysterectomy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Florida A&M University — Tallahassee

Идентификаторы

NCT: NCT06741241 · 2180042-1 · 2U54MD007582-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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