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Trial Title:
Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
NCT ID:
NCT06109870
Condition:
HPV
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PRECEDE-PROCEED
Description:
delivered self-sampling (CHWSS) to increase screening participation.
Arm group label:
PRECEDE-PROCEED
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Texas at Austin
Address:
City:
Austin
Zip:
78712
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marian Williams-Brown, MD
Phone:
512-324-7036
Email:
yvette.brown@austin.utexas.edu
Investigator:
Last name:
Marian Williams-Brown, MD
Email:
Principal Investigator
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jane Montealegre, M. D.
Phone:
281-814-7118
Email:
jrmontealegre@mdanderson.org
Investigator:
Last name:
Jane Montealegre, M. D.
Email:
Principal Investigator
Start date:
October 30, 2023
Completion date:
August 31, 2030
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06109870
http://www.mdanderson.org
