Self-Sampling for Human Papillomavirus (HPV) Testing in African American Women - Mississippi Delta (HPV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03713710|
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Behavioral: Pap testing Behavioral: Choice||Not Applicable|
OBJECTIVE: Our objective is to examine the efficacy and costs of a patient-centered approach ("Choice" between self-sampling and Pap test) in adherence to cervical cancer screening as compared to Pap test at the local health department ("Pap") among un/under-screened African American women in the Mississippi Delta.
HYPOTHESES: Women in the "Choice" arm will have a higher cervical cancer screening adherence as well as higher satisfaction than women assigned to the "Pap" arm; (2) Within the "Choice" arm, more women will choose and complete self-sampling than Pap test; and (3) The "Choice" intervention will be on average less costly and more cost-effective than the "Pap" intervention.
SPECIFIC AIMS: (1) To compare the impact of these two intervention approaches, "Choice" versus "Pap", on cervical cancer screening adherence through a group randomized controlled trial; (2) To compare patient satisfaction between the two intervention approaches; and (3) To compare the costs and cost-effectiveness of these two intervention approaches, "Choice" versus "Pap".
STUDY DESIGN: 12 towns will be randomized to either "Choice" or "Pap" (180 women/arm). Peer Health Educators (PHEs) will identify African American women who report not having undergone cervical cancer screening in the past three years and deliver a brief theory-based, cultural relevant educational session on cervical cancer and screening using a door-to-door approach. Women randomized to the "Pap" arm will be provided with information on how to schedule an appointment at the local health department. Women randomized to the "Choice" arm will be given the choice of attending the health department for a Pap test or self-collecting their own sample at home to be sent for HPV testing. PHEs will follow-up with women in either arm who have a positive test in order to assure diagnostic evaluation and care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Self-Sampling for HPV Testing in African American Women - Mississippi Delta|
|Actual Study Start Date :||November 28, 2016|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Pap testing
Women assigned to this arm will be scheduled a Pap testing appointment at the local health department
Behavioral: Pap testing
Women will be approached in the community by a Peer Health Educator and scheduled an appointment for a Pap testing at the local health department
Women assigned to this arm will be given a choice between scheduling an appointment for a Pap testing at the health department or engage in self-sampling for HPV testing at home
Women will be approached in the community by a Peer Health Educator and they will be given a choice between scheduling an appointment for a Pap testing at the local health department or engage in self-sampling for HPV testing at home
- adherence to cervical cancer screening [ Time Frame: baseline to 30 days ]adherence to cerivcal cancer screening by attending the Pap testing or returning the self-collected sample for HPV testing
- Satisfaction with the intervention [ Time Frame: baseline to 6 months ]We will assess participants' satisfaction with intervention through self-report (satisfaction questionnaire - satisfied/very satisfied)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713710
|United States, Mississippi|
|Mississippi State Department of Health|
|Jackson, Mississippi, United States, 39211|
|Principal Investigator:||Isabel C. Scarinci, PhD||University of Alabama at Birmingham|