The SOLVE-IT National Randomized Trial
SOLVE-IT
SOLVE IT: Real Risk Reduction for MSM
2 other identifiers
interventional
2,020
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2008
CompletedFirst Posted
Study publicly available on registry
April 7, 2008
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
July 16, 2019
CompletedJuly 16, 2019
June 1, 2019
1.3 years
April 3, 2008
August 5, 2015
June 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months
Counts of unprotected anal intercourse (one each for insertive and receptive; UAI) in the past 3 months with a non-primary partner were reported by participants at baseline, and 3 month follow-up. Reports of insertive and receptive anal intercourse per time period were summed. Change in unprotected anal intercourse was calculated at 3 months using residualized change scores (regressing 3-month reported UAI (Y) on baseline UAI. Negative numbers reflect a reduction in UAI over time). Although raw counts of UAI are heavily tailed, residualized change scores yield a normal distribution.
Measured at baseline and 3 month follow-up
Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months
Counts of unprotected anal intercourse (one each for insertive and receptive) in the past 3 months with a non-primary partner were reported by participants at baseline, and 6 month follow-up. Reports of insertive and receptive anal intercourse per time period were summed. Change in unprotected anal intercourse from baseline, was calculated at 6 months using residualized change scores (regressing 6-month reported UAI (Y) on baseline UAI. Negative numbers reflect a reduction in UAI over time). Raw counts of UAI are heavily tailed, but residualized change scores are normally distributed.
Measured at baseline and 6 month follow-up
Secondary Outcomes (1)
Shame Residualized Change
Measured at baseline and Immediate post
Study Arms (2)
SOLVE-IT
EXPERIMENTALParticipants will receive the intervention SOLVE-IT. The SOLVE-IT intervention is a videogame designed to optimize self-regulation, reduce shame, and reduce risky choices for young men who have sex with men (YMSM).
Waitlist Control
ACTIVE COMPARATORParticipants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM, after a 6-month waitlist period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of nonprescription drug injection use
- Has participated in SOLVE-IT at any phase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern California (University Village)
Los Angeles, California, 90007, United States
Related Publications (1)
Read SJ, Miller, LC, Appleby PR, Nwosu ME, Reynaldo S, Lauren A, Putcha A. Socially optimized learning in a virtual environment: Reducing risky sexual behavior among men who have sex with men. Human Communication Research 32(1):1-34, 2006.
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Professor Lynn Carol Miller
- Organization
- Annenberg School for Communication and Journalism, University of Southern California
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn C. Miller, PhD
University of Southern California
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
April 3, 2008
First Posted
April 7, 2008
Study Start
June 1, 2011
Primary Completion
October 1, 2012
Study Completion
May 1, 2013
Last Updated
July 16, 2019
Results First Posted
July 16, 2019
Record last verified: 2019-06