Clinical trial NCT00653991: The SOLVE-IT National Randomized Trial
Official title: SOLVE IT: Real Risk Reduction for MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV/AIDS Prevention
Men Who Have Sex With Men (MSM)
Risky Sexual Behavior
Socially Optimized Learning in a Virtual Environment (SOLVE)
HIV Seronegativity
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-04-07
Enrollment: 2020
Sex: MALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months
timeFrame: Measured at baseline and 3 month follow-up
measure: Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months
timeFrame: Measured at baseline and 6 month follow-up
Secondary outcomes:
measure: Shame Residualized Change
timeFrame: Measured at baseline and Immediate post
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California (University Village)
state: California
Study officials:
affiliation: University of Southern California
name: Lynn C. Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.