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NCT02873741 · ClinicalTrials.gov registry record
New Strategies to Assess Anal Cancer Risk In Women
A clinical trial of Human Immunodeficiency Virus (HIV) and Human Papilloma Virus (HPV), sponsored by Emory University.
- Completed
- Registry status
- 143
- Enrollment target
- 1
- Study location
NCT02873741: Completed study of Human Immunodeficiency Virus (HIV) and Human Papilloma Virus (HPV), sponsored by Emory University.
NCT02873741 is a study of Human Immunodeficiency Virus (HIV) and Human Papilloma Virus (HPV) that has completed, run by Emory University. The registered enrollment target is 143 participants, below the 501-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02873741, a study of Human Immunodeficiency Virus (HIV) and Human Papilloma Virus (HPV), has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 143 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research is to study different strategies to identify women at highest risk for anal cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk Index; it gives women an overall number score based on risk factors that they may have for anal cancer, such as age, number of sexual partners, or smoking. Investigators seek to understand whether women with higher Anal Cancer Risk Index scores are more likely to have abnormal results on anal pap smears, HPV tests, or anal biopsies. The study team will collect swabs of the cervix and the anus to study different laboratory tests that could identify women at highest risk of cervical and anal cancer. These laboratory tests include an anal pap smear, tests for markers of disease and tests that detect the HPV types most likely to cause cancer. The study team would like to see which of these laboratory tests do the best job at predicting precancerous lesions in the anus and are better indicators of risk for cancer. After collecting these swabs, women will have a procedure called high resolution anoscopy where investigators look closely at the anus and biopsy any suspicious areas. Finally, the study team will look for HPV proteins and changes that HPV can make in cells to see if these tests predict anal lesions.
Primary Outcome
Assessment of anal cancer screening, risk factors for anal cancer, and its association with HPV using AIDS Risk Reduction Model Framework, that is a three stage model, including knowledge as a prerequisite to recognize risk and to take action to change or reduce the risk. Knowledge was measured with the Knowledge of Anal cancer and HPV, that is a 44-item knowledge multiple choice survey adapted from the Hild-Mosely, et al study, substituting "cervical" with "anal". A percentage score of correct
Conditions Studied
Interventions
- PROCEDURE Perianal and Digital Anorectal Exam
- PROCEDURE Cervical Swabs
- PROCEDURE Anal Swabs
- PROCEDURE High Resolution Anoscopy (HRA)
Study Locations (1)
Georgia
- The Ponce Center - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2016-07 |
| Est. Completion | 2017-02-27 |
What the finished NCT02873741 record still lists
NCT02873741 is an observational study that tracks outcomes without assigning an intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 501-participant average among 18 other Human Immunodeficiency Virus (HIV) trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Human Immunodeficiency Virus (HIV) appearing as the primary indexed condition, and to 4 interventions - of which Perianal and Digital Anorectal Exam is the first listed.
NCT02873741 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT02873741 about?
NCT02873741 is a clinical study titled "New Strategies to Assess Anal Cancer Risk In Women". The purpose of this research is to study different strategies to identify women at highest risk for anal cancer. Primarily, investigators want to study a risk assessment called the Anal Cancer Risk Index; it gives women an overall number score based on risk factors that they may have for anal cancer...
What is the current status of trial NCT02873741?
This trial is currently completed. The enrollment target is 143 participants. The study started on 2016-07. Estimated completion is 2017-02-27.
What conditions does trial NCT02873741 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus (HIV), Human Papilloma Virus (HPV).
What interventions are being tested in trial NCT02873741?
The interventions under investigation include: Perianal and Digital Anorectal Exam (PROCEDURE), Cervical Swabs (PROCEDURE), Anal Swabs (PROCEDURE), High Resolution Anoscopy (HRA) (PROCEDURE).
Who is sponsoring clinical trial NCT02873741?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02873741 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02873741's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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