NCT03713710

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 18, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

3.1 years

First QC Date

October 18, 2018

Last Update Submit

November 15, 2022

Conditions

Cervical Cancer

Keywords

self-sampling for HPV testing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Satisfaction with the intervention

    baseline to 6 months

Study Arms (2)

Pap testing

EXPERIMENTAL

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

Behavioral: Pap testing

Choice

EXPERIMENTAL

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

Interventions

Pap testingBEHAVIORAL

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

Pap testing
ChoiceBEHAVIORAL

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

Choice

Eligibility Criteria

Age25 Years - 64 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mississippi State Department of Health

Jackson, Mississippi, 39211, United States

Location

Related Publications (1)

  • 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.

    PMID: 33338505DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Vaginal Smears

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, Obstetrical and GynecologicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Isabel C. Scarinci, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

October 18, 2018

First Posted

October 22, 2018

Study Start

November 28, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

November 16, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)