Cultural Acceptability and Feasibility of HPV Cervical Self Collection Aided by Lay Navigators

NCT03139669 | Completed Results

• 1 other identifier: 18473
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Invasive cervical cancer incidence and mortality can be dramatically reduced through early detection and treatment, but many women do not complete screening at recommended intervals. Many low-income women in Virginia remain uninsured and are at significant risk of being medically underserved and failing to complete regular cervical cancer screening. At-home self-collection of specimens for HPV testing is an innovative approach that may increase access to cervical cancer screening in populations that do not participate in traditional clinic-based screening. The proposed community based participatory study aims to determine whether offering at-home self-collection for HPV testing through a lay navigator network is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in the Tobacco Footprint in rural far Southwest Virginia (Health Districts 1, 2 and 3). The procedures will be recruitment of under-screened women in Health Districts 1, 2 and 3 of Southwest Virginia to complete HPV testing using self-collection kits distributed by lay navigators. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.

Conditions

Human Papilloma Virus

Outcome Measures

Primary Outcomes (1)

• Acceptability of At-home Self-collection for HPV Testing Among Under-screened Women in Southwest Virginia.

  ACCEPTABILITY was measured through: uptake of self-collection kit (yes/n).

  1 month

Secondary Outcomes (1)

• Feasibility of Utilizing Lay Navigators to Offer At-home HPV Self-collection as a Strategy to Increase Cervical Cancer Screening Among Under-screened Women in Southwest Virginia.

  1 month

Study Arms (1)

HPV home testing kit

EXPERIMENTAL

The procedures will be recruitment of under-screened women in Health Districts 1, 2 and 3 of Southwest Virginia to complete HPV home testing using self-collection kits distributed by lay navigators. Regardless of HPV positivity, all women will be provided with information about cervical cancer screening (locations, cost, etc.), and will be encouraged to complete Pap screening by a clinician.

Device: Viba collection brush

Interventions

Viba collection brush DEVICE

HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.

HPV home testing kit

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Female
• Live in southwest VA
• Not pregnant-self reported

You may not qualify if:

• History of Papanicolaou test in the last 3 years
• History of hysterectomy or pelvic radiation
• Co-testing (pap test and HPV test at the same time) in the last 5 years
• English speaking

Sponsors & Collaborators

• University of Virginia: lead

Related Publications (9)

• Ackerson K, Gretebeck K. Factors influencing cancer screening practices of underserved women. J Am Acad Nurse Pract. 2007 Nov;19(11):591-601. doi: 10.1111/j.1745-7599.2007.00268.x.

  PMID: 17970859 BACKGROUND

• Arbyn M, Sasieni P, Meijer CJ, Clavel C, Koliopoulos G, Dillner J. Chapter 9: Clinical applications of HPV testing: a summary of meta-analyses. Vaccine. 2006 Aug 31;24 Suppl 3:S3/78-89. doi: 10.1016/j.vaccine.2006.05.117.

  PMID: 16950021 BACKGROUND

• Arbyn M, Verdoodt F, Snijders PJ, Verhoef VM, Suonio E, Dillner L, Minozzi S, Bellisario C, Banzi R, Zhao FH, Hillemanns P, Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014 Feb;15(2):172-83. doi: 10.1016/S1470-2045(13)70570-9. Epub 2014 Jan 14.

  PMID: 24433684 BACKGROUND

• Racey CS, Withrow DR, Gesink D. Self-collected HPV testing improves participation in cervical cancer screening: a systematic review and meta-analysis. Can J Public Health. 2013 Feb 11;104(2):e159-66. doi: 10.1007/BF03405681.

  PMID: 23618210 BACKGROUND

• Gravitt PE, Belinson JL, Salmeron J, Shah KV. Looking ahead: a case for human papillomavirus testing of self-sampled vaginal specimens as a cervical cancer screening strategy. Int J Cancer. 2011 Aug 1;129(3):517-27. doi: 10.1002/ijc.25974.

  PMID: 21384341 BACKGROUND

• Balasubramanian A, Kulasingam SL, Baer A, Hughes JP, Myers ER, Mao C, Kiviat NB, Koutsky LA. Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples. J Low Genit Tract Dis. 2010 Jul;14(3):185-95. doi: 10.1097/LGT.0b013e3181cd6d36.

  PMID: 20592553 BACKGROUND

• Kobetz E, Kish JK, Campos NG, Koru-Sengul T, Bishop I, Lipshultz H, Barton B, Barbee L. Burden of Human Papillomavirus among Haitian Immigrants in Miami, Florida: Community-Based Participatory Research in Action. J Oncol. 2012;2012:728397. doi: 10.1155/2012/728397. Epub 2012 Mar 15.

  PMID: 22619675 BACKGROUND

• Mandigo M, Frett B, Laurent JR, Bishop I, Raymondville M, Marsh S, Kobetz E. Pairing community health workers with HPV self-sampling for cervical cancer prevention in rural Haiti. Int J Gynaecol Obstet. 2015 Mar;128(3):206-10. doi: 10.1016/j.ijgo.2014.09.016. Epub 2014 Nov 11.

  PMID: 25468050 BACKGROUND

• Ely GE, White C, Jones K, Feltner F, Gomez M, Shelton B, Slone S, Van Meter E, Desimone C, Schoenberg N, Dignan M. Cervical cancer screening: exploring Appalachian patients' barriers to follow-up care. Soc Work Health Care. 2014;53(2):83-95. doi: 10.1080/00981389.2013.827149.

  PMID: 24483330 BACKGROUND

Results Point of Contact

• Title: Dr. Emma Mitchell Associate Professor
• Organization: University of Virginia

emm6z@virginia.edu

4342433962

Study Officials

• Emma Mitchell, PhD

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: May 4, 2017
• Study Start: July 1, 2016
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share