- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170534
Intervention for Male STDs in India
August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
An Intervention for Male STD Patients in India
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
1892
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Mumbai, India, 400022
- Lokmanya Tilak Municipal General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Completion
April 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
August 27, 2010
Last Update Submitted That Met QC Criteria
August 26, 2010
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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