Clinical trial NCT02019771: Gonorrhea and Chlamydia HIV-infected Men Who Have Sex With Men
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Chlamydia
Gonorrhea
Keywords: HIV Infection
Men who have sex with men
Chlamydia
Gonorrhea
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 150
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility 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.

Primary outcomes:
measure: Chlamydia or gonorrhea infection
timeFrame: one day
Secondary outcomes:
measure: accuracy for detecting infection when using one versus 2 versus 3 anatomical sites
timeFrame: 1 day
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Specialty Care Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Uriel S Sandkovsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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/JCM.02398-09. Epub 2010 Mar 24.
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 have sex with men in a prospective cohort in Washington, D.C. AIDS Patient Care STDS. 2009 Aug;23(8):585-8. doi: 10.1089/apc.2008.0277. No abstract available.
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 MSM in HIV clinics. Sex Transm Dis. 2010 Dec;37(12):771-6. doi: 10.1097/OLQ.0b013e3181e50058.
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. 2005 Jul 1;41(1):67-74. doi: 10.1086/430704. Epub 2005 May 26.
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):1284-9. doi: 10.1086/508460. Epub 2006 Oct 10.