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HIV InfectionsSOLVE-ITNCT00653991

The SOLVE-IT National Randomized Trial

A study testing SOLVE-IT in people with HIV Infections, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 24 years, men only
Conditions the study is for
HIV Infections
What is being tested?
SOLVE-IT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,020 participants
Where
1 siteUnited States
Study dates
Jun 2011to May 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • History of nonprescription drug injection use
  • Has participated in SOLVE-IT at any phase

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Southern California (University Village)

    Los Angeles, California, 90007

Other trials in United States

About this study

Official title: SOLVE IT: Real Risk Reduction for MSM

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.

Read the 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
Being tested
SOLVE-IT
Keywords
HIV/AIDS Prevention, Men Who Have Sex With Men (MSM), Risky Sexual Behavior, Socially Optimized Learning in a Virtual Environment (SOLVE), HIV Seronegativity
Medical subject headings
HIV Infections, Homosexuality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOLVE-ITBehavioural

    Also called Socially Optimized Learning in Virtual Environments

    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.

Study groups in NCT00653991
Study groupRoleWhat they receive
SOLVE-ITExperimentalParticipants 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).
Receives: Behavioral: SOLVE-IT
Waitlist ControlActive comparatorParticipants 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.
Receives: Behavioral: SOLVE-IT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured at baseline and 3 month follow-up

  2. 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: Measured at baseline and 6 month follow-up

Secondary outcomes (1)

  1. 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: Measured at baseline and Immediate post

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2008 (estimated)
  2. Study startJun 2011
  3. Primary completionOct 2012
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,020 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00653991
Sponsor's protocol ID
R01MH082671
Other IDs
R01MH082671, DAHBR 9A-ASPQ
Acronym
SOLVE-IT
Status last verified
Jun 2019
First submitted
3 Apr 2008
Last updated
16 Jul 2019
Data monitoring committee
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing SOLVE-IT in people with HIV Infections, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months (time frame: Measured at baseline and 3 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00653991, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.

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The SOLVE-IT National Randomized Trial (NCT00653991) | AzTrials