The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Hayley Mark, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01843478
First received: April 26, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted

April 26, 2013
April 26, 2013
October 2012
March 2014   (final data collection date for primary outcome measure)
Pap test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
The outcome measure is the completion of Pap testing within 6 months of the baseline study visit.
Same as current
No Changes Posted
Not Provided
Not Provided
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The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling
A Test of an Intervention to Improve Pap Testing Among Women With HIV

Cervical cancer is the second most common type of cancer among women worldwide. Women with human immunodeficiency virus (HIV) bear a disproportionate burden of cervical cancer and its precursor, cervical intraepithelial neoplasia (CIN), that result from persistent high-risk Human Papillomavirus (HPV) infection. HIV clinical practice guidelines recommend two Pap tests in the year following diagnosis, and if both are normal, yearly thereafter. Nationally, only 25% of women meet this recommendation. The mean annual Pap testing rate for federally funded HIV centers is only 55.7%. In 2009, quality improvement statistics from the Johns Hopkins Hospital Moore Clinic, a large urban HIV center, revealed an annual Pap testing rate of 59%. This occurred despite interventions to address adherence issues were implemented, including nurse case management, co-location of HIV and gynecology services, flexible scheduling, and continuity of care. Women keep their appointments for HIV primary care more often than for gynecology care in the Moore Clinic, so an intervention that takes place during a primary care visit could improve cervical cancer screening rates.

The availability of HPV testing provides a unique opportunity to increase perceived susceptibility to and severity of cervical cancer among women with HIV, and to encourage follow-up Pap testing. HPV testing involves analyzing a sample of cervicovaginal cells for the presence of high-risk HPV strains. Detection of high-risk strains of the virus indicates a high risk for high grade CIN and cancer, while a negative HPV test predicts a less than 2% risk of developing CIN. HPV testing can be easily conducted by women themselves through self-collection in a primary care visit. Studies of women without HIV who do not have regular Pap testing have demonstrated that self-collected HPV testing and results counseling increases the overall screening rate, and women who test positive for HPV have a high rate of follow-up Pap testing. Self-collected HPV testing and results counseling could be utilized in the HIV primary care setting to promote Pap testing among women with HIV.

This study is a randomized trial to test whether receiving self-collected HPV testing and results counseling in HIV primary care will increase completion of Pap testing in a group of women attending the Johns Hopkins Hospital Moore Clinic for HIV Care. The study is informed by the Health Belief Model (HBM), which posits that screening behavior will increase if persons at risk for disease have a cue to action that increases their perception of susceptibility to and severity of the disease. In this study, the HPV test and results counseling are cues to action that also correctly identify those women at high risk for disease. To achieve these aims, 111 women who are late for Pap testing will be recruited for participation while they are at an HIV care appointment. They will be randomized to HPV self-collection and results counseling, or to receive usual care. Six months after enrollment, medical records will be reviewed for completion of Pap testing in the intervening months.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infection
Other: Self-Collected HPV Test
The HPV self-collected test is followed by results counseling by phone when the result is available (usually 2-3 weeks). Women are encouraged to have Pap testing.
Other Name: HPV test (Qiagen hc2)
  • Experimental: HPV Self-Collection
    The intervention is a self-collected HPV test, followed by results counseling by phone when the result is available (usually 2-3 weeks). Women are encouraged to have Pap testing.
    Intervention: Other: Self-Collected HPV Test
  • Placebo Comparator: Usual Care
    In the usual care arm, women do not receive the HPV test. They are encouraged to have Pap testing. In addition, there is a phone call as an attention control, where women are reminded to make a Pap test appointment about 2-3 weeks after the baseline visit.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
111
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

- HIV infection 18 months or more since Pap test Speak & read English Eligible for cervical cancer screening Plans to have Pap testing at Johns Hopkins Hospital

Exclusion Criteria:

- History of hysterectomy Currently pregnant

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01843478
NA_00071156, F31NR013633-01
No
Hayley Mark, Johns Hopkins University
Johns Hopkins University
National Institute of Nursing Research (NINR)
Principal Investigator: Hayley Mark, PhD, MPH, RN Johns Hopkins University
Johns Hopkins University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP