Cervical Carcinoma
Conditions
Brief summary
This clinical trial studies whether a community based intervention improves cervical cancer screening (CCS) among women in the Hispanic and East African immigrant community. Previous research has shown that CCS remains low among women of the Hispanic and East African immigrant community due to lack of awareness about cervical cancer as well as recommended screening guidelines. The community based intervention in this trial will offer CCS in the Hispanic and East African immigrant community using a test that can be completed by the individual. The test uses a brush that is placed inside the vagina to collect a sample. The self-collected sample is then tested for a virus called human papillomavirus (HPV). Because some types of HPV can cause cervical cancer, checking for HPV, may lower a woman's chance of getting cervical cancer. A community based intervention may be an effective way to improve CCS among women in the Hispanic and East African immigrant community.
Interventions
PROCEDUREHPV Self-Collection
Complete self-collection of vaginal HPV sample alone or with clinician assistance
OTHERInformational Intervention
Receive written and video self-collection instructions
OTHERInterview
Participants will be asked to take part in a brief interview to learn about their experience in the clinic and suggestions for improvement
OTHERSurvey Administration
Participants will be asked to take part in a brief survey to learn about their experience in the clinic and suggestions for improvement.
PROCEDUREReceive screening results
Receive testing results
PROCEDUREReceive recommended steps following abnormal results
Receive recommended next steps and primary care team communication
BEHAVIORALTelephone-Based Intervention
May receive verification phone call
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Females self-identifying as belonging to the Hispanic or East African immigrant community * Ages 30-65 years * Intact uterus
Exclusion criteria
* Females who do not identify as belonging to the Hispanic or East African immigrant community * Outside age range of 30-65 years * Self reported history of * Hysterectomy * Cervical cancer * Cervical cancer screening in the last 3 years * Current pregnancy or post-partum in the last 3 months * Positive HIV status * Immunocompromise * Use of vaginal products within 2 days of appointment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of individuals screened in the community via this protocol | Up to 1 year | Assessed by the number of participants who undergo cervical cancer screening. Results will be analyzed descriptively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of abnormal screening results identified | Up to 28 days | Assessed by the number of participants who receive abnormal results such as positive HPV or invalid test result. Results will be analyzed descriptively. |
| Follow up completed | Up to 3 months | Assessed by the number of participants with abnormal screening results who obtained follow-up testing as recommended. Results will be analyzed descriptively. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORJissy Cyriac, MD
Mayo Clinic in Rochester
Outcome results
None listed