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

Completed

• Conditions: Gonorrhea; HIV Infection; Chlamydia

• Registration Number: NCT02019771
• Lead Sponsor: University of Nebraska

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-12-18
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-24
• Study Start: 2014-03-07
• Primary Completion: 2014-10-01
• Study Completion: 2014-10-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Nebraska Medical Center, Specialty Care Center; 🇺🇸 Omaha, Nebraska, United States