Cervical Cancer, HPV Infection
Conditions
Keywords
Cervical cancer screening, Self-collection, At-home HPV test
Brief summary
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.
Interventions
BEHAVIORALQualitative Interview
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).
BEHAVIORALVirtual Visit Standard Instructions
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.
BEHAVIORALVirtual Visit Standard Instructions + In-Person Registration Navigation
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.
Sponsors
Washington University School of Medicine
Teal Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Are age 25 or older * Has an intact cervix * Self-reports that they have not been screened for cervical cancer within the last 3 years for 25-64, 5 years for 65 or older * Has a cellphone that can receive texts (including verification codes) and an email account * Has access to the internet to engage with the Teal Health mobile app and complete a Zoom interview * Can read, speak, write and understand English well enough to take a survey and complete an interview
Exclusion criteria
* Abnormal vaginal bleeding or discharge * A history of cancer of the reproductive system * A compromised immune system * Prior Diethylstilbestrol (DES) exposure * Currently pregnant or are within 6 weeks of giving birth * Treatment for a cervical precancer (e.g., loop electrosurgical excision procedure or conization) in the last 25 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who returned HPV samples | Up to eight weeks after enrollment | 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. |
| Proportion of participants with completed referral visits | Up to eight weeks after enrollment | Outcome will be reported via Pearson's chi-square test. |
| Time to sample return | Up to eight weeks after enrollment | Outcome will be analyzed by nominal regression model. |
| Time to referral | Up to eight weeks after enrollment | Outcome will be analyzed by nominal regression model. |
| Thematic findings addressing opportunity | Eight weeks after enrollment | 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: * What was your reaction for when you were offered the Teal kit? * How did the support from event staff, the virtual care visit, or people in your life influence your decision about using the kit? The following questions on the guide asked to the non-returners of kits: * What, if any, were the barriers that prevented you from completing it? \*Probe: For example, finding the time to use the kit or understanding the instructions * Was there anything that changed between the time you enrolled in the study and receiving the kit that made you decide to not complete the kit? |
| Thematic findings addressing capability | Eight weeks after enrollment | 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: * How confident are you in the results you received? Do you trust them? Why/why not? * Did you feel like you received enough information when you got the kit to know what to do? * How did you feel about your ability to correctly use the self-sampling kit? * Were there any physical difficulties or health issues that made it challenging for you to use the kit? If so, can you describe them? * Do you have any recommendations for improving access to Teal kits for at-home cervical cancer screening? The following will be asked to non-returners of kits: * What suggestions/changes do you think would make it easier for you to use the kit in the future? |
| Thematic findings addressing motivation | Eight weeks after enrollment | 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: * Feelings about cervical cancer screening? * Previous pap smear/HPV test for cervical cancer screening? Describe the experience. * Any concerns/uncertainties you had about using the kit? * What made you decide to use the kit? * What did you like/not like about using the kit? * What things got in the way of using the kit or made it easier? * Would you recommend the kit to a friend? * Would you use the kit in the future? * Thoughts on the importance/urgency of completing the kit? * Explanation of your beliefs about the potential benefits/downsides of using the kit? 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? |
| Thematic findings addressing behavior | Eight weeks after enrollment | 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with positive results who completed follow-up | Up to eight weeks after results available | Outcome will be reported via Pearson's chi-square test. |
Countries
United States
Contacts
CONTACTMichelle Silver, PhD, ScM
PRINCIPAL_INVESTIGATORMichelle Silver, PhD, ScM
Washington University School of Medicine
Outcome results
None listed