Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients

Uterine Cervical Neoplasms Clinical Trial

Official title:

Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427399
• Other study ID #: Cervical Cancer Screening
• Status: Completed
• Phase: N/A
• First received: April 7, 2015
• Last updated: June 19, 2017
• Start date: January 2013
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to determine whether outreach to HIV-negative patients who are overdue for a Pap smear at a New England urban community health center can increase cervical cancer screening rates. It additionally seeks to determine which form of outreach - via letter, email, phone, or a mixture of those modalities- is most effective among these patients.

Description:

To the investigators' knowledge, this study will be the first to assess the efficacy of email in cervical cancer screening outreach in a randomized controlled trial. It will also be one of the few randomized controlled trials to directly compare different outreach media directly, as opposed to different variations within a single medium (e.g. two different types of letters). Lastly, given the unique patient demographic makeup at Fenway, including a significant number of lesbian, bisexual and transgender patients, secondary subanalyses have the potential to significantly add to the investigators' knowledge of what media work best in conducting cervical cancer screening outreach with sexual and gender minorities, who are disproportionately underscreened compared to heterosexual cis-gendered women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: January 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 64 Years

Eligibility

Inclusion Criteria:

• Female or female-to-male transgender patients with a cervix

• HIV-negative

• Medical appointment at Fenway Community Health during calendar year 2012 who have not had a Pap smear in the past 3 years (since January 2010)

Exclusion Criteria:

• HIV-positive (due to different Pap testing guidelines)

• Male-to-female transgender patients

• Patients with a history of a hysterectomy, unless specified as partial or supracervical

• Patients aged 30-64 who had a negative Pap test in the past 5 years with simultaneous negative Human papillomavirus infection (HPV) co-testing

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

Other:
• Letter and informational sheet
The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests.
• Email
The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders.
• Phone
The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
• Multimodal
The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fenway Community Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Who Receive a Pap Test at End of Follow up	The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).	18 months
Secondary	Proportion Receiving Pap Test at 6 Months	The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).	6 months
Secondary	Proportion Receiving Pap Test at 12 Months	The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).	12 months