Gonorrhea and Chlamydia HIV-infected Men Who Have Sex With Men - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Chlamydia Infections Gonorrhea HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Chlamydia or gonorrhea infection [ Time Frame: one day ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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


Ages Eligible for Study:	19 Years and older
Genders 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

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

Publications:

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.

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.

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.

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. Epub 2005 May 26.

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. Epub 2006 Oct 10.

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.


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:	December 2, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:


HIV Infection Men who have sex with men Chlamydia Gonorrhea

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome Chlamydia Infections Communicable Diseases Gonorrhea HIV Infections Infection Bacterial Infections Chlamydiaceae Infections Genital Diseases, Female Genital Diseases, Male Gram-Negative Bacterial Infections	Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections Neisseriaceae Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases

ClinicalTrials.gov processed this record on February 25, 2015