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A Test of an Intervention to Improve Pap Testing Among Women With HIV

Phase 4
18 Years
Open (Enrolling by invite only)
HIV Infection

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Trial Information

A Test of an Intervention to Improve 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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Pap test

Outcome Description:

The outcome measure is the completion of Pap testing within 6 months of the baseline study visit.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Hayley Mark, PhD, MPH, RN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

March 2014

Related Keywords:

  • HIV Infection
  • women
  • human immunodeficiency virus
  • cervical cancer screening
  • Pap testing
  • human papillomavirus
  • HIV Infections
  • Acquired Immunodeficiency Syndrome



Moore Clinic for HIV Care, Johns Hopkins Hospital Baltimore, Maryland  21215