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Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts

Primary Purpose

HIV Infections, Protozoan Infections

Status
Completed
Phase
Locations
Taiwan
Study Type
Observational
Intervention
amoeba
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring protozoa, Amoeba

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • Kaoshing Medical University Chung-Ho Memorial Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 26, 2008
Last Updated
February 2, 2009
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00630162
Brief Title
Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts
Official Title
Survey of Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts
Study Type
Observational

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Protozoan Infections
Keywords
protozoa, Amoeba

7. Study Design

Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
amoeba

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of HIV-1 Disease Clinical diagnosis of Intestinal protozoal infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jih-Jin Tsai, MD
Organizational Affiliation
Chung-Ho Memorial Hospital,Kaohsiung Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Kaoshing Medical University Chung-Ho Memorial Hospital
City
Kaoshiung
Country
Taiwan

12. IPD Sharing Statement

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Intestinal Protozoal Infections and Sexual Transmitted Diseases Among Targeted Cohorts

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