Effectiveness of Interactive Virtual Environment Games in Reducing Risky Sexual Behavior Among Men Who Have Sex With Men (The SOLVE-IT Study) (SOLVE-IT)
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ClinicalTrials.gov Identifier: NCT00653991 |
Recruitment Status
: Unknown
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was: Not yet recruiting
First Posted
: April 7, 2008
Last Update Posted
: March 11, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Socially Optimized Learning in a Virtual Environment (SOLVE)-IT | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 4000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | SOLVE IT: Real Risk Reduction for MSM |
Study Start Date : | October 2010 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: SOLVE-IT
Participants will receive SOLVE-IT.
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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.
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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.
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- Instances of unprotected sex [ Time Frame: Measured at baseline and Months 3 and 6 of follow-up ]
- Affect [ Time Frame: Measured at baseline and Months 3 and 6 of follow-up ]

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Ages Eligible for Study: | 18 Years to 24 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

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): NCT00653991
Contact: Paul R. Appleby, MA, PhD | 213-821-1586 | appleby@usc.edu |
United States, California | |
University of Southern California (University Village) | Not yet recruiting |
Los Angeles, California, United States, 90007 |
Principal Investigator: | Lynn C. Miller, PhD | University of Southern California |
Publications:
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: |
R01MH082671 ( U.S. NIH Grant/Contract ) DAHBR 9A-ASPQ |
First Posted: | April 7, 2008 Key Record Dates |
Last Update Posted: | March 11, 2009 |
Last Verified: | March 2009 |
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |