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| Name | Class |
|---|---|
| Pennsylvania Breast Cancer Coalition | UNKNOWN |
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The goal of this study is to learn if women of Hispanic/Latina ethnicity are willing to self-collect a cervico-vaginal sample for HPV testing. The main question the study will answer is:
• Does a brief educational intervention increase the feasibility and acceptability of HPV self-sampling among Hispanic/Latina women?
The study team will compare whether including a brief educational intervention with a mailed HPV self-sampling kit is more acceptable than receiving a mailed HPV self-sampling kit alone.
Participants will be asked to complete surveys at study entry (baseline) and then randomized to receive only the HPV self-sampling kit, or the kit plus a small group education that meets with a bilingual health educator.
Participants will then be contacted about one-month later to complete a follow-up survey. The study team will also measure the number of participants in each group who self-collect a sample and mail it in for HPV testing.
The study team will recruit a sample of underscreened Latinas (n=100) who will be randomly assigned to either the educational intervention (n=50) or a control condition (n=50). Feasibility will be measured through study enrollment and intervention completion (defined as the proportion of women who self-collect a sample). Acceptability of intervention materials and self-sampling procedures will be measured using self-report surveys at follow-up assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mailed Kit Only Control | Active Comparator | Participants receive an HPV self-sampling kit in the mail with instructions on how to self-collect a sample and return it to the lab for testing. |
|
| Education Plus Mailed Kit | Experimental | Participants receive information about cervical cancer risks and screening guidelines in a small-group format with a bilingual health educator. Participants also receive an HPV self-sampling kit in the mail with instructions on how to self-collect a sample and return it to the lab for testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPV Self-Sampling | Behavioral | HPV self-sampling kit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility | The number of participants in the intervention arm who attend at least one session | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Participation in screening | The number of participants who return a self-collected sample | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Fang, PhD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40349085 | Derived | Fang CY, Cora-Cruz M, Koirala P, Perez S, Li M, Egleston BL, Chen Y, Mantia-Smaldone G, Martinez O. Juntas Contra el Virus del Papiloma Humano: protocol for a pilot randomized controlled trial of an HPV self-sampling intervention for underscreened Latinas. Pilot Feasibility Stud. 2025 May 10;11(1):65. doi: 10.1186/s40814-025-01648-y. |
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De-identified data and associated documentation can be made available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. All procedures will be compliant with NIH regulations on the distribution of unique research resources.
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Group Education | Behavioral | Small-group education led by bilingual health educator |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |