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

Florida A&M University

Status: Begins enrollment in 4 months

Conditions: Cervical Cancer Screening

Treatments: Behavioral: eHealth Promotora; Behavioral: eHealth Healthy Nutrition

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06741241

2180042-1

2U54MD007582-39 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. between the age of 21 and 65 years
2. identify as Hispanic
3. 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]
4. have no history of cervical cancer
5. have not had a hysterectomy.

Exclusion criteria

1. under the age of 21 or over the age of 65 years
2. do not identify as Hispanic
3. up-to-date with cervical cancer screening [last Pap test < 3 years - based on U.S. Preventive Services Task Force guidelines]
4. history of cervical cancer
5. have had a hysterectomy.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

eHealth Promotora

Experimental group

Description:

Intervention arm participants will participate in a eHealth promotora group education session to receive a presentation on cervical cancer screening education, view an educational video, and complete baseline and 6-month follow-up surveys.

Treatment:

Behavioral: eHealth Promotora

eHealth Healthy Nutrition

Active Comparator group

Description:

Control group participants will participate in an eHealth group education session to receive a presentation on healthy nutrition information, view an educational video, and complete baseline and 6-month surveys.

Treatment:

Behavioral: eHealth Healthy Nutrition