Uniting Trusted Community Messengers to Improve Access to Cervical Cancer Screening in Rural North Carolina

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-64
SponsorUNC Lineberger Comprehensive Cancer Center

About this trial

The purpose of this study is to test the feasibility and acceptability of a multi-level, community-engaged intervention to increase access to cervical cancer screening using human papillomavirus (HPV) self-collection (HPVSC) outreach among women living in a high-risk rural county and to improve navigation for follow-up screening.

A one-group intervention evaluation design will be used to pilot test feasibility and acceptability and to assess the proportion of women who return HPVSC kits and test HPV-positive. At the community level, local community-based organizations (CBOs) will serve as HPVSC kit distribution sites. At the individual level, trained community health workers will work with CBOs to support women throughout the HPVSC process, including specimen collection, kit return, result notification, and follow-up clinic-based screening for women who test HPV-positive.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Resident of Lenoir County and 12 community.

have not received a Pap test within the last 3.5 years, or an HPV test in the last 5.5 years

female ≥ 30 to 64 years of age at time of recruitment

Disqualifiers

65 years of age or older had a hysterectomy,

history of cervical cancer,

plan to move from Lenoir County during the study period.

community health workers

Trial design

Design model

Single group

Treatments tested in this trial

  • Human papilloma virus screening

    Diagnostic test

    Human papilloma virus self-collection (HPVSC) kits will be provided to screen HPV.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: WomanExperimental treatment 1 intervention
Group B: Community partnersNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recruitment and enrollment rate

Proportion of eligible unscreened women recruited, with a target enrollment of 100 participants from Lenoir County.

Time frame
Up to 6 months
2

Retention rate

Ratio of returned HPV self-collection kits to kits distributed, and rate of participant withdrawal or loss to follow-up.

Time frame
Up to 6 months
3

HPV positive screening rate

Rate of HPV-positive screening rate among woman started study will be reported.

Time frame
Up to 6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNC Lineberger Comprehensive Cancer Center

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: