HIV InfectionNCT02019771
Gonorrhea and Chlamydia HIV-infected Men Who Have Sex With Men
An observational study of HIV Infection and Chlamydia, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- HIV Infection, Chlamydia, Gonorrhea
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2014to 1 Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Specialty Care Center
Omaha, Nebraska, 68198-8106
About this study
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
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.
Read the 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.
- Conditions
- HIV Infection, Chlamydia, Gonorrhea
- Keywords
- HIV Infection, Men who have sex with men, Chlamydia, Gonorrhea
- Medical subject headings
- HIV Infections, Chlamydia Infections, Gonorrhea, Homosexuality
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start7 Mar 2014
- Primary completion1 Oct 2014
- Study completion1 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uriel S Sandkovsky, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019771
- Sponsor's protocol ID
- 0025-14-FB
- Status last verified
- Sep 2023
- First submitted
- 18 Dec 2013
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23033514Bachmann 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.
PubMed 20335410Baker 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.
PubMed 19591608Hoover 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.
PubMed 20585275Kent 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.
PubMed 15937765Morris 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.
PubMed 17051493
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02019771
- Acronym / sponsor ID
- 0025-14-FB
- Conditions
- HIV Infection, Chlamydia, Gonorrhea
- Keywords
- HIV Infection, Men who have sex with men, Chlamydia, Gonorrhea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 7 Mar 2014 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
accuracy for detecting infection when using one versus 2 versus 3 anatomical sites
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 23033514Koedijk 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.
- Results publication: PubMed 20335410Bachmann 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.
- Results publication: PubMed 19591608Baker 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.
- Results publication: PubMed 20585275Hoover 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.
- Results publication: PubMed 15937765Kent 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.
- Results publication: PubMed 17051493Morris 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uriel S Sandkovsky, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and Chlamydia, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chlamydia or gonorrhea infection (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019771, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.