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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
First received
Last updated
Start date October 30, 2023
Est. completion date August 31, 2030

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Jane Montealegre, M D
Phone (281) 814-7118
Email jrmontealegre@mdanderson.org
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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