The SOLVE-IT National Randomized Trial

NCT ID: NCT00653991

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2020 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

SOLVE-IT

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

SOLVE-IT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Socially Optimized Learning in Virtual Environments

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Lynn Miller

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lynn C. Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California (University Village)

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

R01MH082671

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR 9A-ASPQ

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH082671

Identifier Type: NIH

Identifier Source: org_study_id

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