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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-09607 | Other Identifier | NCI-CTRP Clinical Registry |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRECEDE-PROCEED | Experimental | To identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRECEDE-PROCEED | Behavioral | delivered self-sampling (CHWSS) to increase screening participation. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jane Montealegre, M D | Contact | (281) 814-7118 | jrmontealegre@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Jane Montealegre, M D | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas at Austin | Recruiting | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40674748 | Derived | 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/AOG.0000000000006003. Epub 2025 Jul 17. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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