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Clinical Trials/NCT00653991
NCT00653991CompletedNot Applicable

SOLVE IT: Real Risk Reduction for MSM

University of Southern California2 sites in 1 country2,020 target enrollmentStarted: June 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,020
Locations
2
Primary Endpoint
Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 24 Years (Adult)
Sex
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

Arms & Interventions

SOLVE-IT

Experimental

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).

Intervention: SOLVE-IT (Behavioral)

Waitlist Control

Active Comparator

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.

Intervention: SOLVE-IT (Behavioral)

Outcomes

Primary Outcomes

Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months

Time Frame: 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.

Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months

Time Frame: 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.

Secondary Outcomes

  • Shame Residualized Change(Measured at baseline and Immediate post)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lynn Miller

Study Principal Investigator

University of Southern California

Study Sites (2)

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