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Completed

NCT Number: NCT00630162

Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts

In this two-year study, we will target two high risk groups, including MSM of HIV-infected and those of non-HIV-infected. We will avail the serodiagnosis to detect the potential amebic carriers in both groups; and use microscopy to detect protozoas other than amebiasis. Meanwhile we will also survey the patients' status of sexual transmitted diseases (STD). For the amebic carriers, we will apply specific antigen and molecular biologic method to follow up the duration of the persistence of fecal amebas. We try to clarify the dynamic change of amebic carriage.

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Key information

About this study

HIV-infected persons who are men having sex with men (MSM) are prone to acquire invasive amebiasis. It would cast great threat for public health if the pathogens are spread by way of human to human transmission and food contamination.

From 2000 to 2004, we assessed the seroprevalence of Entamoeba histolytica infection using indirect hemagglutination antibody (IHA) assay among 667 HIV-infected persons (group 1), 1311 asymptomatic HIV-uninfected persons seeking anonymous HIV testing (group 2), 616 HIV-uninfected controls with gastrointestinal symptoms (diarrhea and/or liver abscess) seeking medical care (group 3), and 2500 healthy controls undergoing health check-up (group 4). An IHA titer greater than 128 was detected in 7.1% of group 1, 2.5% of group 2, 1.8% of group 3, and 0.1% of group 4 (p<0.0001). The highest seroprevalence (11.2%) was noted among HIV-infected persons who were MSM aged 30 to 39 years. Compared with persons with gastrointestinal symptoms, the adjusted odds ratio for having high IHA titers among HIV-infected persons was 3.206 (95% confidence interval, 1.433, 7.176) (p=0.005). These findings demonstrate that HIV-infected persons, especially MSM aged 30 to 39 years, are at significantly higher risk of E. histolytica infection.

In this two-year study, we will target two high risk groups, including MSM of HIV-infected and those of non-HIV-infected. We will avail the serodiagnosis to detect the potential amebic carriers in both groups; and use microscopy to detect protozoas other than amebiasis. Meanwhile we will also survey the patients' status of sexual transmitted diseases (STD). For the amebic carriers, we will apply specific antigen and molecular biologic method to follow up the duration of the persistence of fecal amebas. We try to clarify the dynamic change of amebic carriage.

We anticipate this study could outline the epidemiology and risk factors of protozoal infections and STD in MSM cohorts. We also hope to reduce the the infection rate (protozoa and HIV) and disease rate (STD) through the repetitively effective health education and consultation during the conduct of this study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of HIV-1 Disease
  • Clinical diagnosis of Intestinal protozoal infections

Treatment and study plan

amoeba

Genetic

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Survey of Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts

Important dates

Study start
2007
Study completion
2008
First posted
Mar 6, 2008
Registry last updated
Feb 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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