The SOLVE-IT National Randomized Trial

Study Overview
=================
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.

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.

Official Title
-----------------
SOLVE IT: Real Risk Reduction for MSM

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: SOLVE-IT


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOLVE-IT<br>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<br>* 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.<br>* Other names: Socially Optimized Learning in Virtual Environments;|
| Active Comparator: Waitlist Control<br>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<br>* 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.<br>* Other names: Socially Optimized Learning in Virtual Environments;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shame Residualized Change | 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. | Measured at baseline and Immediate post | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Socially Optimized Learning in a Virtual Environment (SOLVE), HIV Seronegativity, HIV/AIDS Prevention, Men Who Have Sex With Men (MSM), Risky Sexual Behavior