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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03713710
Acronym
HPV
Enrollment
335
Registered
2018-10-22
Start date
2016-11-28
Completion date
2019-12-31
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Keywords

self-sampling for HPV testing

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.

Interventions

BEHAVIORALPap 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

BEHAVIORALChoice

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

Sponsors

American Cancer Society, Inc.
CollaboratorOTHER
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
adherence to cervical cancer screeningbaseline to 30 daysadherence to cerivcal cancer screening by attending the Pap testing or returning the self-collected sample for HPV testing

Secondary

MeasureTime frameDescription
Satisfaction with the interventionbaseline to 6 monthsWe will assess participants' satisfaction with intervention through self-report (satisfaction questionnaire - satisfied/very satisfied)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026