A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)
|ClinicalTrials.gov Identifier: NCT01198418|
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : April 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Sexually Transmitted Infections HIV Infections||Behavioral: Experimental||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||181 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||August 2013|
|Experimental: Internet-based counseling||
Internet-based intervention that assesses transmission risk and provides prevention messages
|No Intervention: Survey Alone|
- STI incidence [ Time Frame: Baseline and follow-up visits every 3 months ]
- 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 ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|