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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02019771
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : August 21, 2017
Information provided by (Responsible Party):
Uriel Sandkovsky, MD, University of Nebraska

Brief Summary:

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.

Condition or disease
HIV Infection Chlamydia Gonorrhea

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Study Type : Observational
Actual Enrollment : 150 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02019771

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United States, Nebraska
Specialty Care Center
Omaha, Nebraska, United States, 68198-8106
Sponsors and Collaborators
University of Nebraska
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Principal Investigator: Uriel S Sandkovsky, MD University of Nebraska
Publications of Results:

Other Publications:
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Responsible Party: Uriel Sandkovsky, MD, Assistant Professor Medicine, University of Nebraska Identifier: NCT02019771    
Other Study ID Numbers: STD-MSM-HIV
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Keywords provided by Uriel Sandkovsky, MD, University of Nebraska:
HIV Infection
Men who have sex with men
Additional relevant MeSH terms:
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HIV Infections
Chlamydia Infections
Communicable Diseases
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial
Neisseriaceae Infections