Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida
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|ClinicalTrials.gov Identifier: NCT02202109|
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : November 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Behavioral: CHW and Self-sampling for Cervical Cancer Behavioral: Mailed Self Sampler||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||602 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Addressing Cervical Cancer Disparity in South Florida: CBPR in Action|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
Active Comparator: CHWs facilited Self-Sampling
CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
Behavioral: CHW and Self-sampling for Cervical Cancer
Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
Active Comparator: Mailed Self-Sampler
Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone
Behavioral: Mailed Self Sampler
Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
- Having a self sampling test done [ Time Frame: 6 months ]The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.
- Cervical Cancer Knowledge and Access to Care [ Time Frame: 6 months ]Cervical Cancer Knowledge: Baseline and follow-up knowledge information will also be examined as a secondary outcome. Access to Care: We will also examine access to care (having health insurance, usual of care of care and visits to a provider) as additional secondary outcome.
- Number of participant who used the mailed Self Sampler [ Time Frame: 6 months ]To determine if the method of delivery of the self sampler affected screening and if one of the two planned intervention was more efficacious among women in one location versus another. In addition using data obtained from our study questionnaire, we will also examine if there was a differential impact of the intervention among women who were uninsured, lower education, lower acculturation level or had lower levels of baseline cervical cancer knowledge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202109
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Erin Kobetz, PhD||University of Miami|