Effectiveness of Interactive Virtual Environment Games in Reducing Risky Sexual Behavior Among Men Who Have Sex With Men (The SOLVE-IT Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00653991
First received: April 3, 2008
Last updated: March 10, 2009
Last verified: March 2009

April 3, 2008
March 10, 2009
October 2010
December 2012   (final data collection date for primary outcome measure)
Instances of unprotected sex [ Time Frame: Measured at baseline and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653991 on ClinicalTrials.gov Archive Site
Affect [ Time Frame: Measured at baseline and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effectiveness of Interactive Virtual Environment Games in Reducing Risky Sexual Behavior Among Men Who Have Sex With Men (The SOLVE-IT Study)
SOLVE IT: Real Risk Reduction for MSM

This study will evaluate the effectiveness of an interactive virtual environment computer game in reducing risky sexual behaviors among men who have sex with men.

HIV and sexually transmitted diseases (STDs) are a major public health concern worldwide. Although prevalent across all groups of people, HIV/STDs have had a remarkable effect on men who have sex with men (MSM), who accounted for 71% of all HIV infections among American males in 2005. After years of decline, the number of HIV diagnoses appears to have increased for MSM, especially within the black MSM population. Thus, new approaches geared for HIV prevention and education and built on past HIV prevention methods are needed. New technologies, such as interactive computer games, delivered in a modern and appealing manner may gain or recapture the attention of MSM who have disregarded more traditional HIV prevention and educational services. Socially Optimized Learning in a Virtual Environment (SOLVE)-IT is an interactive virtual environment computer game, designed specifically for MSMs, that simulates the emotional, interpersonal, and contextual narrative of an actual sexual encounter and provides challenging decision-making opportunities. By promoting development of self-regulatory and behavioral skills, SOLVE-IT may be an effective approach to reduce sexual risk behaviors. This study will evaluate the effectiveness of SOLVE-IT in reducing risky sexual behaviors among MSM.

Participation in this study will last 6 months from the beginning of treatment. All participants will first undergo baseline assessments that will include questionnaires about sexual behavior, drug use, health history, feelings, and beliefs. Participants will then be assigned randomly to receive SOLVE-IT immediately or after a 6-month waitlist period. SOLVE-IT will include two 1-hour sessions conducted on a computer over the Internet, occurring at baseline and 6 months later. During sessions, participants will play an interactive computer game that presents dating or sexual scenarios and allows participants to choose how the scenarios unfold. Participants will repeat baseline questionnaires at Months 3 and 6 of follow-up. Participants in the waitlist group will be offered to receive SOLVE-IT after completion of the Month 6 follow-up.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Behavioral: Socially Optimized Learning in a Virtual Environment (SOLVE)-IT
SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM. Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context.
  • Experimental: SOLVE-IT
    Participants will receive SOLVE-IT.
    Intervention: Behavioral: Socially Optimized Learning in a Virtual Environment (SOLVE)-IT
  • Active Comparator: Waitlist Control
    Participants will receive SOLVE-IT after a 6-month waitlist period.
    Intervention: Behavioral: Socially Optimized Learning in a Virtual Environment (SOLVE)-IT
  • Appleby, P. R., Godoy, C. G., Miller, L. C., & Read, S. J. (2008). Reducing risky sex through the use of interactive video technology. In T. Edgar, S. M. Noar, & V. S. Freimuth (Eds.) Communication perspectives on HIV/AIDS for the 21st century (pp.379-384). New York: Lawrence Erlbaum Associates Taylor & Francis Group.
  • Read, S. J., Miller, L. C., Appleby, P. R., Nwosu, M. E., Reynaldo, S., Lauren, A., & Putcha, A. (2006). Socially optimized learning in a virtual environment: Reducing risky sexual behavior among men who have sex with men. Human Communication Research, 32, 1-34.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
4000
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Self-identifies as Latino, black, or Caucasian
  • Men who have sex with men
  • Not HIV infected
  • Engaged in unprotected anal sex at least twice in the 90 days before study entry with a nonprimary male partner
  • Has broadband access during course of study
  • Lives in United States
  • Biological male

Exclusion Criteria:

  • History of nonprescription drug injection use
  • Has participated in SOLVE-IT at any phase
Male
18 Years to 24 Years
No
Contact: Paul R. Appleby, MA, PhD 213-821-1586 appleby@usc.edu
United States
 
NCT00653991
R01 MH082671, DAHBR 9A-ASPQ
No
Lynn Carol Miller, PhD, Professor, Annenberg School for Communication, University of Southern California
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Lynn C. Miller, PhD University of Southern California
National Institute of Mental Health (NIMH)
March 2009

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