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Self-Sampling for Human Papillomavirus (HPV) Testing in African American Women - Mississippi Delta (HPV)

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ClinicalTrials.gov Identifier: NCT03713710
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Isabel Scarinci, University of Alabama at Birmingham

Brief Summary:
The purpose of this study is to examine the efficacy and costs of this patient-centered approach ("Choice" between two cervical cancer screening modalities) in adherence to cervical cancer screening as compared to the current standard of care within the public health system in Mississippi (Pap test at the local department -"Pap") among un/under-screened African American women in the Mississippi Delta using a theory-based, culturally relevant intervention implemented by Peer Health Educators (PHEs).

Condition or disease Intervention/treatment Phase
Cervical Cancer Behavioral: Pap testing Behavioral: Choice Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Self-Sampling for HPV Testing in African American Women - Mississippi Delta
Actual Study Start Date : November 28, 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Choice
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
Behavioral: Choice
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • no personal history of cervical cancer
  • not have engaged in cervical cancer screening in the past four years

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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): NCT03713710


Contacts
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Contact: Isabel C Scarinci, PhD 205-975-7177 scarinci@uab.edu

Locations
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United States, Mississippi
Mississippi State Department of Health Recruiting
Jackson, Mississippi, United States, 39211
Contact: Laura Tucker, RN    662-453-4563    Laura.Tucker@msdh.ms.gov   
Principal Investigator: Isabel C Scarinci, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
American Cancer Society, Inc.
Investigators
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Principal Investigator: Isabel C. Scarinci, PhD University of Alabama at Birmingham

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Responsible Party: Isabel Scarinci, Primary Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03713710     History of Changes
Other Study ID Numbers: X161101004
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isabel Scarinci, University of Alabama at Birmingham:
self-sampling for HPV testing
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female