The SOLVE-IT National Randomized Trial

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT00653991
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 2,020
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 87.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: SOLVE-IT	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2020 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: Jun 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SOLVE-IT Participants 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).	Behavioral: 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.; Other Names: Socially Optimized Learning in Virtual Environments
Active Comparator: Waitlist Control Participants 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.	Behavioral: 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.; Other Names: Socially Optimized Learning in Virtual Environments

Outcome Measures

Primary Outcome Measures

1. Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months [Measured at baseline and 3 month follow-up]

   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.

2. Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months [Measured at baseline and 6 month follow-up]

   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.

Secondary Outcome Measures

1. Shame Residualized Change [Measured at baseline and Immediate post]

   Measures of reported shame (five items from an existing subscale of Watson and Clark's (1994) Positive and Negative Affect Schedule- Expanded Form-- designed to assess State Shame): ashamed, blameworthy, angry at self, disgusted with self, dissatisfied with self. Participants indicate to what extent they experienced emotions that were part of this sub scale, responding on a scale from 1 (very slightly or not at all) to 5(extremely). Values reported represent the mean value per participant on the State Shame subscale; values per participant on this subscale therefore ranged from 1 to 5. Higher scores represent a higher level of reported state shame. Scores on this scale are heavily tailed. Therefore, we have consistently used residualized change scores: This is calculated from baseline to immediate post; negative numbers for residualized change mean reduced shame baseline to immediate post.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Southern California (University Village)	Los Angeles	California	United States	90007

Sponsors and Collaborators

• University of Southern California
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Lynn C. Miller, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Lynn Miller, Study Principal Investigator, University of Southern California
• ClinicalTrials.gov Identifier: NCT00653991
• Other Study ID Numbers: R01MH082671; R01MH082671; DAHBR 9A-ASPQ
• First Posted: Apr 7, 2008
• Last Update Posted: Jul 16, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Lynn Miller, Study Principal Investigator, University of Southern California: 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

Study Results

Participant Flow

Pre-assignment Detail	Allocation 1284 SOLVE-IT (Met exclusion: 573 incomplete baseline; 257 didn't play game; 10 technical glitch) Allocation 736 Control (Met exclusion: 202 didn't complete baseline; 43 had technical glitch).

Arm/Group Title	SOLVE-IT	Waitlist Control
Arm/Group Description	Participants 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). 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.	Participants 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. 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.
Period Title: 3 Month Follow-up
STARTED	444	491
COMPLETED	294	334
NOT COMPLETED	150	157
Period Title: 3 Month Follow-up
STARTED	444	491
COMPLETED	311	350
NOT COMPLETED	133	141

Baseline Characteristics

Arm/Group Title	SOLVE-IT	Waitlist Control	Total
Arm/Group Description	Participants 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). 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.	Participants 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. 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.	Total of all reporting groups
Overall Participants	444	491	935
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	444 100%	491 100%	935 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.3 (1.7)	21.3 (1.8)	21.3 (1.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	444 100%	491 100%	935 100%
Race/Ethnicity, Customized (participants) [Number]
White/Caucasian	338 76.1%	349 71.1%	687 73.5%
Latino/Hispanic	55 12.4%	76 15.5%	131 14%
Black/African American	51 11.5%	66 13.4%	117 12.5%
Region of Enrollment (participants) [Number]
United States	444 100%	491 100%	935 100%
Counts of unprotected anal intercourse (UAI) past 3 months (counts) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [counts]	11.7 (12.5)	12.5 (11.8)	12.12 (12.14)
Level of shame (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.7 (.77)	1.7 (.82)	1.7 (.80)

Outcome Measures

1. Primary Outcome

Title	Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months
Description	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.
Time Frame	Measured at baseline and 3 month follow-up

Outcome Measure Data

Analysis Population Description

In SOLVE-IT at 3 months, 10 multivariate outliers were excluded based on Mahalanobis distance; in Wait-list Control 12 multivariate outliers were excluded.

Arm/Group Title	SOLVE-IT	Waitlist Control
Arm/Group Description	Participants 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). 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.	After a 3-month waitlist period, participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM. 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.
Measure Participants	284	322
Mean (Standard Deviation) [Res. Change in Counts of UAI at 3 months]	.10 (6.67)	-.09 (9.95)

2. Primary Outcome

Title	Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months
Description	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.
Time Frame	Measured at baseline and 6 month follow-up

Outcome Measure Data

Analysis Population Description

Here we use only complete data for a given analysis. Using Mahlolanobis distance critical values 11 participants in the SOLVE-IT group and 5 participants in the Waitlist Control were multivariate outliers.

Arm/Group Title	SOLVE-IT	Waitlist Control
Arm/Group Description	Participants 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). 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.	After a 6-month waitlist period, participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM. 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.
Measure Participants	300	345
Mean (Standard Deviation) [Change in Counts of UAI at 6 months]	-.48 (3.95)	.41 (4.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SOLVE-IT, Waitlist Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<.001
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Shame Residualized Change
Description	Measures of reported shame (five items from an existing subscale of Watson and Clark's (1994) Positive and Negative Affect Schedule- Expanded Form-- designed to assess State Shame): ashamed, blameworthy, angry at self, disgusted with self, dissatisfied with self. Participants indicate to what extent they experienced emotions that were part of this sub scale, responding on a scale from 1 (very slightly or not at all) to 5(extremely). Values reported represent the mean value per participant on the State Shame subscale; values per participant on this subscale therefore ranged from 1 to 5. Higher scores represent a higher level of reported state shame. Scores on this scale are heavily tailed. Therefore, we have consistently used residualized change scores: This is calculated from baseline to immediate post; negative numbers for residualized change mean reduced shame baseline to immediate post.
Time Frame	Measured at baseline and Immediate post

Outcome Measure Data

Analysis Population Description

At baseline 443 (of 444) SOLVE-IT and 491 WLC filled out the shame measure, but 7 per condition responded with "refuse to answer". A technical glitch post-game (that affected immediate post baseline measures only) resulted in 337 participants in SOLVE-IT but 482 WLC responding to immediate post.

Arm/Group Title	SOLVE-IT	Waitlist Control
Arm/Group Description	Participants 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). 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.	Participants 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. 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.
Measure Participants	337	482
Mean (Standard Deviation) [score on a scale]	-.13 (.65)	.09 (.03)

Adverse Events

Time Frame	6 months per participant in the main study
Adverse Event Reporting Description	An approved data and safety monitoring plan stated that if three or more adverse events (e.g., distress, upset) occurred in a single arm, the trial would be stopped and evaluated. An adverse event form was developed for this purpose. Staff was trained to notify the Co-PI (and he the PI) immediately if one occurred (no adverse event occurred).
Arm/Group Title	SOLVE-IT		Waitlist Control
Arm/Group Description	Participants 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). 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.		Participants 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. 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.
All Cause Mortality
	SOLVE-IT		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SOLVE-IT		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/444 (0%)		0/491 (0%)
Other (Not Including Serious) Adverse Events
	SOLVE-IT		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/444 (0%)		0/491 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.