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| Name | Class |
|---|---|
| Teal Health, Inc. | INDUSTRY |
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This study is testing and implementing an equity-focused, community-based intervention that improves women's access to cervical cancer screening and adherence to follow up after an abnormal result. The study's objective is to assess and compare the feasibility of different methods of distributing at-home HPV testing kits for cervical cancer screening among individuals who are under-screened.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 1: Standard instructions | Active Comparator | Participants will complete a sociodemographic questionnaire and will receive the standard instructions. After approximately 8 weeks, participants will be asked to participate in the qualitative interview. |
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| Aim 1: Standard instructions + in-person guidance | Experimental | Participants will complete a sociodemographic questionnaire and will receive the standard instructions and in-person navigation for registering for a consult to receive the at-home testing kit. After approximately 8 weeks, participants will be asked to participate in the qualitative interview. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualitative Interview | Behavioral | Participants will participate in a semi-structured qualitative interview conducted with a research coordinator and guided by the Capability, Opportunity, Motivation, Behavior model (COM-B). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who returned HPV samples | Feasibility of the distribution methods between groups will be measured by the return rate of at home, self-collected HPV samples. Outcome will be reported via Pearson's chi-square test. | Up to eight weeks after enrollment |
| Proportion of participants with completed referral visits | Outcome will be reported via Pearson's chi-square test. | Up to eight weeks after enrollment |
| Time to sample return | Outcome will be analyzed by nominal regression model. | Up to eight weeks after enrollment |
| Time to referral | Outcome will be analyzed by nominal regression model. | Up to eight weeks after enrollment |
| Thematic findings addressing opportunity | Will be assessed during semi-structured interviews with participants and analyzed according to the Capability, Opportunity, Motivation, Behavior (COM-B) model. Questions during the semi-structure interview will follow a guide. Answers to the questions will be analyzed for thematic findings. The following questions on the guide asked to the returners of kits:
The following questions on the guide asked to the non-returners of kits:
| Eight weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with positive results who completed follow-up | Outcome will be reported via Pearson's chi-square test. | Up to eight weeks after results available |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Silver, PhD, ScM | Contact | 314-454-7903 | michelle.silver@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Silver, PhD, ScM | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Virtual Visit Standard Instructions | Behavioral | Participants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit. |
|
| Virtual Visit Standard Instructions + In-Person Registration Navigation | Behavioral | Participants will be given information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their Teal At-Home cervical cancer screening kit. Participants will scan the QR code and complete the registration process onsite with a study coordinator, leaving the event with a scheduled date and time for their telehealth appointment. |
|
| Thematic findings addressing capability | Will be assessed during semi-structured interviews with participants & analyzed according to the COM-B model. Questions during the semi-structure interview will follow a guide. Answers will be analyzed for thematic findings. The following will be asked to returners of kits:
The following will be asked to non-returners of kits:
| Eight weeks after enrollment |
| Thematic findings addressing motivation | Will be assessed during semi-structured interviews with participants & analyzed according to COM-B model. Questions will follow a guide. Answers will be analyzed for thematic findings. The following will be asked to returners of kits:
The following will be asked to non-returners of kits: -Can you describe any situations/experiences/barriers that influenced your decision not to complete & return the kit? | Eight weeks after enrollment |
| Thematic findings addressing behavior | Will be assessed during semi-structured interviews with participants and analyzed according to the COM-B model. Questions during the semi-structure interview follow a guide. Answers to the questions will be analyzed for thematic findings. The following questions on the guide asked to all participants: -Before receiving the kit, what were some of the reasons you were overdue for cervical cancer screening? | Eight weeks after enrollment |
| 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 |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |