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Intervention for Male STDs in India

Primary Purpose

Sexually Transmitted Infection

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Behavior
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infection focused on measuring India, male, sexually transmitted infection, STI, STD

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Males, over 16 years of age Hindu or Marathi speakers Have no plan to move permanently out of Mumbia in the following 12 months 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. Patients will be required to provide an address that can be located by a tracer. Exclusion Criteria: 1. HIV positive subjects.

Sites / Locations

  • Lokmanya Tilak Municipal General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00170534
Brief Title
Intervention for Male STDs in India
Official Title
An Intervention for Male STD Patients in India
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infection
Keywords
India, male, sexually transmitted infection, STI, STD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
1892 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Behavior

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males, over 16 years of age Hindu or Marathi speakers Have no plan to move permanently out of Mumbia in the following 12 months 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. Patients will be required to provide an address that can be located by a tracer. Exclusion Criteria: 1. HIV positive subjects.
Facility Information:
Facility Name
Lokmanya Tilak Municipal General Hospital
City
Mumbai
ZIP/Postal Code
400022
Country
India

12. IPD Sharing Statement

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Intervention for Male STDs in India

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