Overview

This trial is active, not recruiting.

Conditions hiv, syphilis, herpesvirus 2, human
Treatment behavior intervention and male circumcision
Phase phase 3
Sponsor National Center for AIDS/STD Control and Prevention, China CDC
Collaborator Yunnan Center for Disease Control and Prevention
Start date June 2009
End date November 2010
Trial size 3214 participants
Trial identifier NCT01068015, Intervention20100105

Summary

The purpose of this study is to evaluate the effectiveness of the community based comprehensive HIV/STIs intervention among MSMs in China.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
This arm receives free circumcision service, POL intervention, intensive HIV counseling and intensive condom promotion.
behavior intervention and male circumcision
MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion.
(No Intervention)
This arm receives no extra HIV prevention services.
behavior intervention and male circumcision
MSM in intervention arm can receive circumcision service for free, POL intervention, intensive HIV counseling and intensive condom promotion.

Primary Outcomes

Measure
HIV incidence
time frame: March 1,2010 to Dec,31,2010

Secondary Outcomes

Measure
Syphilis, HSV-2 incidence
time frame: 1,Mar.,2009 to 31,Dec,2010
Frequency of condom uses, number of sexual partners
time frame: March, 1, 2010 to December, 31,2010
The proportion of people who have intention to be circumcised
time frame: March, 1, 2010 to December, 31,2010
The proportion of people who have been circumcised
time frame: March, 1, 2010 to December, 31, 2010

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - 18 years or above - Male have oral sex or anal sex within 6 months with a man - Accept questionnaire survey and blood test - Can participate in three surveys in one year - HIV Negative - No mental disease and can understand informed consent Exclusion Criteria: -

Additional Information

Official title A COMMUNITY-BASED, RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF COMPREHENSIVE HIV/STIs INTERVENTION AMONG MEN WHO HAVE SEX WITH MEN IN 8 CITIES IN CHINA
Principal investigator Zunyou Wu, MD, PHD
Description National sentinel surveillance data show that HIV infections are increasing fast among men who have sex with men(MSM) in China. In some cities HIV prevalence among MSM is higher than 10%.It is urgent for China to explore innovative intervention to reduce HIV/AIDS transmission among this population. The purposes of this study are: 1. To evaluate the effectiveness of comprehensive interventions to decrease the HIV/STIs incidence among MSM population in China. The comprehensive intervention components include male circumcision, POL intervention, HIV testing and counseling and condom promotion. 2. To determine the acceptability of male circumcision among MSM population in China.
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by National Center for AIDS/STD Control and Prevention, China CDC.