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

NCT ID: NCT03713710

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-28
• Study Completion Date: 2019-12-31

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).

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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Pap testing

Women assigned to this arm will be scheduled a Pap testing appointment at the local health department

Group Type: EXPERIMENTAL

Pap testing

Intervention Type: BEHAVIORAL

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 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

Group Type: EXPERIMENTAL

Choice

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Isabel Scarinci

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isabel C. Scarinci, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Mississippi State Department of Health

Jackson, Mississippi, United States

Countries

United States

References

Scarinci IC, Li Y, Tucker L, Campos NG, Kim JJ, Peral S, Castle PE. Given a choice between self-sampling at home for HPV testing and standard of care screening at the clinic, what do African American women choose? Findings from a group randomized controlled trial. Prev Med. 2021 Jan;142:106358. doi: 10.1016/j.ypmed.2020.106358. Epub 2020 Dec 16.

Reference Type: DERIVED

PMID: 33338505 (View on PubMed)

Other Identifiers

X161101004

Identifier Type: -

Identifier Source: org_study_id