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

Sponsor
University of Nebraska (Other)
Overall Status
Completed
CT.gov ID
NCT02019771
Collaborator
(none)
150
Enrollment
1
Location
9
Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 2014
    Actual Primary Completion Date :
    Oct 1, 2014
    Actual Study Completion Date :
    Oct 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Chlamydia or gonorrhea infection [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Specialty Care Center Omaha Nebraska United States 68198-8106

    Sponsors and Collaborators

    • University of Nebraska

    Investigators

    • Principal Investigator: Uriel S Sandkovsky, MD, University of Nebraska

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Uriel Sandkovsky, MD, Assistant Professor Medicine, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT02019771
    Other Study ID Numbers:
    • STD-MSM-HIV
    First Posted:
    Dec 24, 2013
    Last Update Posted:
    Aug 21, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by Uriel Sandkovsky, MD, Assistant Professor Medicine, University of Nebraska
    HIV Infection
    Men who have sex with men
    Chlamydia
    Gonorrhea
    Additional relevant MeSH terms:
    Infections
    HIV Infections
    Chlamydia Infections
    Gonorrhea

    Study Results

    No Results Posted as of Aug 21, 2017