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Completed

NCT Number: NCT03713710

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

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).

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Key information

Age range

25 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mississippi State Department of Health

Jackson, Mississippi, 39211, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Pap testing

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

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

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

Acronym: HPV

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2018
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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