Clinical trial NCT06741241: Effectiveness of an EHealth Intervention for Uptake of Cervical Cancer Screening in Hispanic Women
Official title: Effectiveness of an EHealth Intervention for Uptake of Cervical Cancer Screening in Hispanic Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancer Screening
Lead sponsor: Florida A&M University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-12-18
Enrollment: 170
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the eHealth promotora intervention where they will participate in a group education session of cervical cancer screening or a control group where they will participate in a group education session on healthy nutrition.
Primary purpose: SCREENING

Brief summary: 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: 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.

Primary outcomes:
measure: Cervical cancer screening uptake
timeFrame: 6 months
Secondary outcomes:
measure: Cervical cancer screening self-efficacy
timeFrame: 6 months
measure: Cervical cancer knowledge
timeFrame: 6 months
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida A&M University
state: Florida
Study officials:
References: