Gonorrhea and Chlamydia HIV-infected Men Who Have Sex With Men

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Uriel Sandkovsky, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT02019771
First received: December 18, 2013
Last updated: December 24, 2013
Last verified: December 2013

December 18, 2013
December 24, 2013
January 2014
June 2014   (final data collection date for primary outcome measure)
Chlamydia or gonorrhea infection [ Time Frame: one day ] [ Designated as safety issue: No ]
Investigators will use nucleic acid amplification tests in urine, rectal and oropharyngeal swab specimens to detect asymptomatic chlamydia and/or gonorrhea infection
Chlamydia or gonorrhea infection [ Time Frame: one day ] [ Designated as safety issue: No ]
We will use nucleic acid amplification tests in urine, rectal and oropharyngeal swab specimens to detect asymptomatic chlamydia and/or gonorrhea infection
Complete list of historical versions of study NCT02019771 on ClinicalTrials.gov Archive Site
accuracy for detecting infection when using one versus 2 versus 3 anatomical sites [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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.
accuracy for detecting infection when using one versus 2 versus 3 anatomical sites [ Time Frame: 1 day ] [ Designated as safety issue: No ]
We 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.
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Gonorrhea and Chlamydia HIV-infected Men Who Have Sex With Men
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

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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

This 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
  • Chlamydia
  • Gonorrhea
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
August 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Women.
  • Inability to complete the questionnaire in English or Spanish.
Male
19 Years and older
No
United States
 
NCT02019771
STD-MSM-HIV
No
Uriel Sandkovsky, MD, University of Nebraska
University of Nebraska
Not Provided
Principal Investigator: Uriel S Sandkovsky, MD University of Nebraska
University of Nebraska
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP