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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01843478
Recruitment Status : Completed
First Posted : April 30, 2013
Last Update Posted : December 12, 2017
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
HIV Infection Other: Self-Collected HPV Test Other: Usual Care Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Test of an Intervention to Improve Pap Testing Among Women With HIV
Actual Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
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)

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.
Other: Usual Care

Primary Outcome Measures :
  1. Pap test [ Time Frame: 6 months ]
    The outcome measure is the completion of Pap testing within 6 months of the baseline study visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01843478

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United States, Maryland
Moore Clinic for HIV Care, Johns Hopkins Hospital
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
Johns Hopkins University
National Institute of Nursing Research (NINR)
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Principal Investigator: Hayley Mark, PhD, MPH, RN Johns Hopkins University

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Responsible Party: Johns Hopkins University Identifier: NCT01843478     History of Changes
Other Study ID Numbers: NA_00071156
F31NR013633-01 ( U.S. NIH Grant/Contract )
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Keywords provided by Johns Hopkins University:
human immunodeficiency virus
cervical cancer screening
Pap testing
human papillomavirus
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases