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NCT01843478 · ClinicalTrials.gov registry record · NA
The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 97
- Enrollment target
NCT01843478: Completed NA study, sponsored by Johns Hopkins University.
NCT01843478 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 97 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01843478, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 97 participants
- Enrollment target
Study 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. Sel
Interventions
- OTHER Usual Care
- OTHER Self-Collected HPV Test
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2012-10 |
| Est. Completion | 2014-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01843478
The ClinicalTrials.gov registry entry for NCT01843478 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.
NCT01843478 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01843478 about?
NCT01843478 is a clinical study titled "The Self-Collection Study: a Study of Self-collected HPV Testing and Results Counseling". 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...
What is the current status of trial NCT01843478?
This trial is currently completed. It is a NA study. The enrollment target is 97 participants. The study started on 2012-10. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01843478?
The interventions under investigation include: Usual Care (OTHER), Self-Collected HPV Test (OTHER).
Who is sponsoring clinical trial NCT01843478?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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