A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
University of Southern California
California HIV/AIDS Research Program
Information provided by (Responsible Party):
California Collaborative Treatment Group
ClinicalTrials.gov Identifier:
NCT01198418
First received: September 8, 2010
Last updated: March 31, 2014
Last verified: March 2014

September 8, 2010
March 31, 2014
November 2010
August 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01198418 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Web-based Intervention Study to Reduce High-risk Sexual Behavior by Persons Living With HIV AIDS (PLWH)
A Randomized Controlled Clinical Trial of an Internet-based Prevention Intervention to Reduce STI in High-risk HIV Infected MSM

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sexually Transmitted Infections
  • HIV Infections
Behavioral: Experimental
Internet-based intervention that assesses transmission risk and provides prevention messages
  • Experimental: Internet-based counseling
    Intervention: Behavioral: Experimental
  • No Intervention: Survey Alone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
August 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 infection, as documented by any licensed screening antibody test, such as ELISA, and confirmed by a second antibody test, such as Western blot, or detectable plasma HIV-1 RNA at any time prior to study entry. If an ELISA or Western Blot are not available, HIV infection may be documented by two HIV RNA values > 2000 copies/mL, drawn at least 24 hours apart. The HIV RNA assays should have been run at a CLIA approved laboratory or equivalent.
  • 18 years of age or older.
  • Male.
  • At least one of the following:
  • An HIV negative or unknown status sexual partner in the past three months.
  • A sexually transmitted disease in the past 1 year (other than HIV).
  • More than 2 male partners in past year.
  • Unprotected anal sex in past 3 month.
  • Capable of signing written informed consent.
  • Read and comprehend English
  • Adequate computer skills for study.

Exclusion Criteria:

  • Uncontrolled psychiatric condition.
  • Drug or alcohol users with use that in the opinion of the investigator, would limit follow-up and adequate consent
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01198418
CCTG 592
No
California Collaborative Treatment Group
California Collaborative Treatment Group
  • University of California, Los Angeles
  • University of Southern California
  • California HIV/AIDS Research Program
Study Chair: Sheldon Morris, MD, MPh California Collaborative Treatment Group
Study Chair: Joel Milam, PhD California Collaborative Treatment Group
California Collaborative Treatment Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP