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

HIV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02019771
• Other study ID #: 0025-14-FB
• Status: Completed
• Start date: March 7, 2014
• Est. completion date: October 1, 2014

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 1, 2014
• Est. primary completion date: October 1, 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chlamydia
• Chlamydia Infections
• Gonorrhea
• HIV Infection
• HIV Infections
• Infections

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Specialty Care Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bachmann LH, Johnson RE, Cheng H, Markowitz L, Papp JR, Palella FJ Jr, Hook EW 3rd. Nucleic acid amplification tests for diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis rectal infections. J Clin Microbiol. 2010 May;48(5):1827-32. doi: 10.1128 — View Citation

Baker J, Plankey M, Josayma Y, Elion R, Chiliade P, Shahkolahi A, Menna M, Miniter K, Slack R, Yang Y, Masterman B, Margolick JB. The prevalence of rectal, urethral, and pharyngeal Neisseria gonorrheae and Chlamydia trachomatis among asymptomatic men who — View Citation

Hoover KW, Butler M, Workowski K, Carpio F, Follansbee S, Gratzer B, Hare B, Johnston B, Theodore JL, Wohlfeiler M, Tao G, Brooks JT, Chorba T, Irwin K, Kent CK; Evaluation Group for Adherence to STD and Hepatitis Screening. STD screening of HIV-infected — View Citation

Kent CK, Chaw JK, Wong W, Liska S, Gibson S, Hubbard G, Klausner JD. Prevalence of rectal, urethral, and pharyngeal chlamydia and gonorrhea detected in 2 clinical settings among men who have sex with men: San Francisco, California, 2003. Clin Infect Dis. — View Citation

Koedijk FD, van Bergen JE, Dukers-Muijrers NH, van Leeuwen AP, Hoebe CJ, van der Sande MA; Dutch STI centres. The value of testing multiple anatomic sites for gonorrhoea and chlamydia in sexually transmitted infection centres in the Netherlands, 2006-2010. Int J STD AIDS. 2012 Sep;23(9):626-31. doi: 10.1258/ijsa.2012.011378. — View Citation

Morris SR, Klausner JD, Buchbinder SP, Wheeler SL, Koblin B, Coates T, Chesney M, Colfax GN. Prevalence and incidence of pharyngeal gonorrhea in a longitudinal sample of men who have sex with men: the EXPLORE study. Clin Infect Dis. 2006 Nov 15;43(10):128 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chlamydia or gonorrhea infection	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	accuracy for detecting infection when using one versus 2 versus 3 anatomical sites	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