A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)
This is a CCTG sponsored trial in collaboration with UCSD-AVRC investigators to get more information about the methods that are used on the internet to provide information on how to reduce the risk of giving or getting infections that are often or usually passed from one person to another during sexual or intimate contact (sexually transmitted infection (STI)). STIs include chlamydia, gonorrhea and syphilis. The purpose of this study is to develop methods that will allow someone who is living with HIV an easy way that they can get information and learn of ways on their own that can decrease their chances of getting sexually transmitted infections and ways that they can reduce the chance that they may transmit HIV to others.
Sexually Transmitted Infections
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM|
- STI incidence [ Time Frame: Baseline and follow-up visits every 3 months ] [ Designated as safety issue: No ]
- To compare the composite STI incidence of syphilis or Chlamydia trachomatis (CT) or Neisseria gonorrhea (GC) at any mucosal site among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.
- To compare the incidence of nonspecific urethritis by urinalysis and testing for Mycoplasma genitalum and trichomonas sp. among sexually active HIV-infected men during 12 months participation in an Internet risk reduction intervention compared to those that receive a survey instrument alone.
- Evaluate risk factors of STIs [ Time Frame: Baseline, follow-up visits every 3 months ] [ Designated as safety issue: No ]
- Compare:a)self reported levels of unsafe sex among HIV-infected men b)intention to start ARV among HIV-infected men not currently on ARV will increase during 12 mos. participation in an internet risk reduction intervention compared to survey instrument alone
- Compare self-reported among HIV-infected men during 12 mos. participation as measured by those reporting 100% disclosure in an internet risk reduction intervention compared to survey instrument alone
- Collect genital tract secretions of semen for future study
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: Internet-based counseling||
Internet-based intervention that assesses transmission risk and provides prevention messages
|No Intervention: Survey Alone|
Design: CCTG 592 is a randomized, controlled study that will compare the efficacy of web-based intervention to reduce high-risk sexual behavior by persons living with HIV AIDS (PLWH).
Duration: 48 weeks
Sample Size: 200 subjects (100 per arm) that will be randomized
Study Population: HIV-1-infected men who have sex with men (MSM) at least 18 years of age who have a recent history of transmission risk behavior.
Stratification: Subjects will be stratified based upon their baseline antiretroviral use, whether they have a home computer and by site.
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|University of California, San Diego|
|San Diego, California, United States, 92103|
|University of California, Los Angeles (Harbor)|
|Torrance, California, United States, 90502|
|Study Chair:||Sheldon Morris, MD, MPh||California Collaborative Treatment Group|
|Study Chair:||Joel Milam, PhD||California Collaborative Treatment Group|