Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PRECEDE-PROCEED.
- Who it may be relevant to
- Registry conditions: HPV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 and other low- resource communities in Texas.
The specific aims of this protocol are to:
Specific Aim 1: Determine the feasibility of CHW-SS in the RGV and other low-resource communities in Texas (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 and other low-resource communities in Texas.
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.
Interventions
- Behavioral PRECEDE-PROCEED
delivered self-sampling (CHWSS) to increase screening participation.
Primary outcome measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [Time frame: through study completion; an average 1 year.]
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 or other low-resource community in Texas
- Stated willingness to comply with all study procedures
- Females; Age ≥25 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Texas at Austin — Austin
- M D Anderson Cancer Center — Houston
Publications
- Fallah PN, Bowman P, Tran C, Chen V, Pippin M, Varon ML, Baker E, Milan J, Parker SL, Lezama-Sierra J, Munsell MF, Desravines N, Lavie I, Batman S, Montealegre J, Schmeler KM, Williams-Brown MY, Salcedo MP. Implementation of Human Papillomavirus Self-Collection and Barriers to Follow-Up Among Unhoused Individuals in Texas: The EMPOWER Study. Obstet Gynecol. 2025 Nov 1;146(5):710-717. doi: 10.1097/ PMID 40674748
Identifiers
NCT: NCT06109870 · 2023-0529 · NCI-2023-09607