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
  Purpose

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
HIV Infection
Chlamydia
Gonorrhea

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: January 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders 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

Criteria

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
Choosing 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
United States, Nebraska
Specialty Care Center Not yet recruiting
Omaha, Nebraska, United States, 68198-8106
Contact: Uriel S Sandkovsky, MD    402-559-8664    usandkovsky@unmc.edu   
Contact: Deanna Hansen    4025595392    dmhansen@unmc.edu   
Principal Investigator: Uriel S Sandkovsky, MD         
Sub-Investigator: Sara Bares, MD         
Sub-Investigator: Susan Swindells, MBBS         
Sub-Investigator: Patrick Passarelli         
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Uriel S Sandkovsky, MD University of Nebraska
  More Information

Publications:

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: December 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
HIV Infection
Men who have sex with men
Chlamydia
Gonorrhea

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Chlamydia Infections
Gonorrhea
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Genital Diseases, Male
Genital Diseases, Female
Neisseriaceae Infections

ClinicalTrials.gov processed this record on September 16, 2014