A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)
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|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198418
|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|