The SOLVE-IT National Randomized Trial

University of Southern California

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: SOLVE-IT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00653991

R01MH082671 (U.S. NIH Grant/Contract)

DAHBR 9A-ASPQ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,020 patients

Sex: Male

Ages: 18 to 24 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,020 participants in 2 patient groups

SOLVE-IT

Experimental 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).

Treatment:

Behavioral: SOLVE-IT

Waitlist Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: SOLVE-IT