Trial record 10 of 39 for:    " April 02, 2008":" May 02, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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.


Condition Intervention
HIV Infections
Behavioral: Socially Optimized Learning in a Virtual Environment (SOLVE)-IT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: SOLVE IT: Real Risk Reduction for MSM

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Instances of unprotected sex [ Time Frame: Measured at baseline and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Affect [ Time Frame: Measured at baseline and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOLVE-IT
Participants will receive SOLVE-IT.
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.
Active Comparator: Waitlist Control
Participants will receive SOLVE-IT after a 6-month waitlist period.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 24 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00653991

Contacts
Contact: Paul R. Appleby, MA, PhD 213-821-1586 appleby@usc.edu

Locations
United States, California
University of Southern California (University Village) Not yet recruiting
Los Angeles, California, United States, 90007
Sponsors and Collaborators
Investigators
Principal Investigator: Lynn C. Miller, PhD University of Southern California
  More Information

Publications:
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.

Responsible Party: Lynn Carol Miller, PhD, Professor, Annenberg School for Communication, University of Southern California
ClinicalTrials.gov Identifier: NCT00653991     History of Changes
Other Study ID Numbers: R01 MH082671, DAHBR 9A-ASPQ
Study First Received: April 3, 2008
Last Updated: March 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
HIV/AIDS Prevention
Men Who Have Sex With Men (MSM)
Risky Sexual Behavior
Socially Optimized Learning in a Virtual Environment (SOLVE)
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014