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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Sexually Transmitted Infections
HIV Infections
 Behavioral: Experimental
 Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by California Collaborative Treatment Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Enrollment: 181
Study Start Date: November 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet-based counseling Behavioral: Experimental
Internet-based intervention that assesses transmission risk and provides prevention messages
No Intervention: Survey Alone

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198418

Locations
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
Sponsors and Collaborators
California Collaborative Treatment Group
University of California, Los Angeles
University of Southern California
California HIV/AIDS Research Program
Investigators
Study Chair: Sheldon Morris, MD, MPh California Collaborative Treatment Group
Study Chair: Joel Milam, PhD California Collaborative Treatment Group
  More Information

No publications provided

Responsible Party: California Collaborative Treatment Group
ClinicalTrials.gov Identifier: NCT01198418     History of Changes
Other Study ID Numbers: CCTG 592
Study First Received: September 8, 2010
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by California Collaborative Treatment Group:
STI
MSM
HIV
Prevention
Men having sex with men

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases

ClinicalTrials.gov processed this record on March 01, 2015