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Intervention for Male STDs in India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170534
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : August 27, 2010
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The specific aim of this study is to complete an ongoing randomized controlled trial of the efficacy of behavioral intervention compared to STI treatment/HIV counseling alone in decreasing risk behavior and incident HIV/STI infections in Mumbai, India.

Condition or disease Intervention/treatment Phase
Sexually Transmitted Infection Behavioral: Behavior Not Applicable

Detailed Description:
India has the second highest number of HIV infections of any country in the world, and the epidemic continues unabated. This trial is focused on high risk men attending public STI clinics. A proposed 2 and a half year study, this trial will utilize the continuation of a randomized controlled trial of a behavioral intervention compared to HIV C&T and STI treatment alone targeting HIV uninfected male STI patients. The specific aims are to complete the current behavioral intervention trial and to expand the current investigations to include: the evaluation of men who have sex with men as well as women and evaluate the use of alcohol to the entire sample of recruited men. STI patients will be recruited from three sites and if randomized will agree to a 12 month participation commitment. Strategies employed in both arms of the trial are simple and the fundamental components of an HIV prevention strategy. By demonstrating their effectiveness in India the hope is to encourage the public health leadership to adopt them and continue to change drug treatment availability.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1892 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: An Intervention for Male STD Patients in India
Study Start Date : October 2004
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Males, over 16 years of age
  2. Hindu or Marathi speakers
  3. Have no plan to move permanently out of Mumbia in the following 12 months
  4. have a symptom of an STI or have had a sexual exposure in the past 6 months. A sexual exposure is defined as having sex with a commercial sex worker (FSW), having unprotected sex with anyone, male or female, or if the patient came to the clinic seeking an HIV test.
  5. Patients will be required to provide an address that can be located by a tracer.

Exclusion Criteria:

1. HIV positive subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170534

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Lokmanya Tilak Municipal General Hospital
Mumbai, India, 400022
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

Layout table for additonal information Identifier: NCT00170534     History of Changes
Other Study ID Numbers: 02-106
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: April 2009
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
India, male, sexually transmitted infection, STI, STD
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female