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NCT00170534 Clinical Trial

Intervention for Male STDs in India

Sexually Transmitted Infection Clinical Trial

Official title:
An Intervention for Male STD Patients in India

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00170534
Other study ID # 02-106
Secondary ID
Status Terminated
Phase N/A
First received September 12, 2005
Last updated August 26, 2010
Start date October 2004
Est. completion date April 2007

Study information
Verified date April 2009
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 1892
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 16 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Behavior

Locations
Country Name City State
India Lokmanya Tilak Municipal General Hospital Mumbai

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

India, 

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