Gonorrhea and Chlamydia HIV-infected Men Who Have Sex With Men
University of Nebraska
Information provided by (Responsible Party)
Uriel Sandkovsky, MD, University of Nebraska
First received: December 18, 2013
Last updated: August 16, 2017
Last Verified: August 2017
History of Changes
Hypothesis: Men who have sex with men (MSM) are at higher risk for sexually transmitted
diseases. Currently, free testing for sexually transmitted diseases is only being performed
in urine samples. Investigators hypothesize that the rates of both gonorrhea and chlamydia
will be higher when testing includes more than one anatomical site (rectum and oropharynx).
The aim of the study is to estimate the rates of asymptomatic Chlamydia and/or Gonorrhea in the oropharynx, rectum and urethra (urine) of HIV infected men who have sex with men at the specialty care center of the University of Nebraska Medical Center and compare to the rates in Douglas County, using nucleic acid amplification tests.
Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Prevalence of Gonorrhea and Chlamydia Infections in Multiple Anatomical Sites in HIV-infected Men Who Have Sex With Men at an HIV Clinic in Omaha, Nebraska|
Further study details as provided by Uriel Sandkovsky, MD, University of Nebraska:
Primary Outcome Measures
Chlamydia or gonorrhea infection
[ Time Frame: one day ]
Investigators will use nucleic acid amplification tests in urine, rectal and oropharyngeal swab specimens to detect asymptomatic chlamydia and/or gonorrhea infection
- accuracy for detecting infection when using one versus 2 versus 3 anatomical sites
[ Time Frame: 1 day ]
Investigators will compare the proportion of infections detected by using only urine, only rectum, only oropharynx vs. using combined sites (urine and rectum, urine and oropharynx or oropharynx and rectum) vs. using all 3 sites.
|Study Start Date:||January 2014|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
|Ages Eligible for Study:||19 Years and older|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Study PopulationThis cross-sectional study will be conducted at the Specialty Care Center of the University of Nebraska Medical Center, in Omaha, Nebraska. Adult men who have a history of sex with men who visit the clinic for their appointments will be eligible to participate in the study
- HIV infection
- Men with history of sex with men (including transgender and bisexual)
- Older than 19 years of age
- Asymptomatic at the time of visit.
- Active sexually transmitted disease symptoms in the oropharynx.
- Recent treatment for Chlamydia or gonorrhea within 3 weeks.
- Treatment with antibiotics active for Chlamydia or gonorrhea within the last 2 weeks: doxycycline, quinolones and azithromycin, and cefixime.
- Inability to complete the questionnaire in English or Spanish.
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02019771
Locations Show More
|United States, Nebraska|
|Specialty Care Center|
|Omaha, Nebraska, United States, 68198-8106|
Sponsors and CollaboratorsUniversity of Nebraska
|Principal Investigator:||Uriel S Sandkovsky, MD||University of Nebraska|
|Responsible Party:||Uriel Sandkovsky, MD, Assistant Professor Medicine, University of Nebraska|
|ClinicalTrials.gov Identifier:||NCT02019771 History of Changes|
|Other Study ID Numbers:||STD-MSM-HIV|
|Study First Received:||December 18, 2013|
|Last Updated:||August 16, 2017|
Keywords provided by Uriel Sandkovsky, MD, University of Nebraska:HIV Infection
Men who have sex with men
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.