Clinical Trials

MainTitle

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

This study has been completed
Sponsor
University of Nebraska


Information provided by (Responsible Party)
Uriel Sandkovsky, MD, University of Nebraska

ClinicalTrials.gov Identifier
NCT02019771

First received: December 18, 2013
Last updated: August 16, 2017
Last Verified: August 2017
History of Changes
Purpose

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

Further study details as provided by Uriel Sandkovsky, MD, University of Nebraska:

Primary Outcome Measures

  • 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:
  • 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.

Enrollment: 150
Study Start Date: January 2014
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: 19 Years and older  
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

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

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
Omaha, Nebraska, United States, 68198-8106

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator: Uriel S Sandkovsky, MD University of Nebraska
More Information

More Information


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: August 16, 2017  

Keywords provided by Uriel Sandkovsky, MD, University of Nebraska:

HIV Infection
Men who have sex with men
Chlamydia
Gonorrhea

Additional relevant MeSH terms:
Infection
Chlamydia Infections
Gonorrhea
HIV Infections

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.