The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/14/2017 |
| Start Date: | October 2012 |
| End Date: | March 2014 |
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.
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.
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
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