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Completed

NCT Number: NCT02019771

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

This study will 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 a specialty care center and compare it to the rates in Douglas County, using nucleic acid amplification tests.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2013
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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