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

September 1, 2023 updated by: University of Nebraska

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198-8106
        • University of Nebraska Medical Center, Specialty Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

December 18, 2013

First Posted (Estimated)

December 24, 2013

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0025-14-FB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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