Clinical trial NCT02427399: Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients
Official title: Conducting Outreach to Improve Cervical Cancer Screening Rates Among Underscreened Patients at an Urban Community Health Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Patients Who Receive a Pap Test at End of Follow up
timeFrame: 18 months
Secondary outcomes:
measure: Proportion Receiving Pap Test at 6 Months
timeFrame: 6 months
measure: Proportion Receiving Pap Test at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Fenway Community Health
name: Jennifer Potter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peitzmeier SM, Khullar K, Potter J. Effectiveness of four outreach modalities to patients overdue for cervical cancer screening in the primary care setting: a randomized trial. Cancer Causes Control. 2016 Sep;27(9):1081-91. doi: 10.1007/s10552-016-0786-6. Epub 2016 Jul 22.