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

Cervical Cancer Clinical Trial

— HPV  

Official title:

Self-Sampling for HPV Testing in African American Women - Mississippi Delta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713710
• Other study ID #: X161101004
• Status: Completed
• Phase: N/A
• Start date: November 28, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

Inclusion Criteria:

• no personal history of cervical cancer

• not have engaged in cervical cancer screening in the past four years

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Mississippi State Department of Health	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adherence to cervical cancer screening	adherence to cerivcal cancer screening by attending the Pap testing or returning the self-collected sample for HPV testing	baseline to 30 days
Secondary	Satisfaction with the intervention	We will assess participants' satisfaction with intervention through self-report (satisfaction questionnaire - satisfied/very satisfied)	baseline to 6 months