Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening

HPV Clinical Trial

Official title:

Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109870
• Other study ID #: 2023-0529
• Secondary ID: NCI-2023-09607
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: August 31, 2030

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jane Montealegre, M D
• Phone: (281) 814-7118
• Email: jrmontealegre[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.

Description:

Primary Objectives: The overall purpose of this protocol is to evaluate the feasibility and acceptability of CHW-delivered selfsample HPV testing (CHW-SS) to increase cervical cancer screening among women in RGV, a lowresource community in Texas. The specific aims of this protocol are to: Specific Aim 1: Determine the feasibility of CHW-SS in the RGV (i.e., reach, screening uptake, notification of test results). Specific Aim 2: Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV. Secondary Objectives: Exploratory Aim 3: Assess attendance for clinical follow-up among individuals who participate in CHW-SS and test positive for HR-HPV. Exploratory Aim 4: Evaluate contextual fit of the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 920
• Est. completion date: August 31, 2030
• Est. primary completion date: August 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following

criteria:

• Provision of signed and dated informed consent form
• Currently resident in RGV
• Stated willingness to comply with all study procedures
• Females; Age =30 years
• Have no history of hysterectomy with removal of the cervix
• Have no history of cervical cancer or high-grade dysplasia
• have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation

in this study:

• Unable to communicate in English or Spanish
• Lack valid telephone contact information
• Report being currently pregnant. 4.3 Vulnerable Populations

Related Conditions & MeSH terms

• HPV
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• PRECEDE-PROCEED
delivered self-sampling (CHWSS) to increase screening participation.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0		through study completion; an average 1 year.

External Links

•   M D Anderson Cancer Center