HIV Infections
Conditions
Keywords
HIV/AIDS Prevention, Men Who Have Sex With Men (MSM), Risky Sexual Behavior, Socially Optimized Learning in a Virtual Environment (SOLVE), HIV Seronegativity
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.
Interventions
BEHAVIORALSOLVE-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.
Sponsors
National Institute of Mental Health (NIMH)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 24 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months | 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. |
| Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shame Residualized Change | Measured at baseline and Immediate post | 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. |
Countries
United States
Participant flow
Pre-assignment details
1. Allocation 1284 SOLVE-IT (Met exclusion: 573 incomplete baseline; 257 didn't play game; 10 technical glitch) 2. Allocation 736 Control (Met exclusion: 202 didn't complete baseline; 43 had technical glitch).
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 444 |
| 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.
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. | 491 |
| Total | 935 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Month Follow-up | Participant would not respond | 150 | 157 |
| 6 Month Follow-up | Participant would not respond | 133 | 141 |
Baseline characteristics
| Characteristic | SOLVE-IT | Waitlist Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 444 Participants | 491 Participants | 935 Participants |
| Age, Continuous | 21.3 years STANDARD_DEVIATION 1.7 | 21.3 years STANDARD_DEVIATION 1.8 | 21.3 years STANDARD_DEVIATION 1.8 |
| Counts of unprotected anal intercourse (UAI) past 3 months | 11.7 counts STANDARD_DEVIATION 12.5 | 12.5 counts STANDARD_DEVIATION 11.8 | 12.12 counts STANDARD_DEVIATION 12.14 |
| Level of shame | 1.7 units on a scale STANDARD_DEVIATION 0.77 | 1.7 units on a scale STANDARD_DEVIATION 0.82 | 1.7 units on a scale STANDARD_DEVIATION 0.8 |
| Race/Ethnicity, Customized Black/African American | 51 participants | 66 participants | 117 participants |
| Race/Ethnicity, Customized Latino/Hispanic | 55 participants | 76 participants | 131 participants |
| Race/Ethnicity, Customized White/Caucasian | 338 participants | 349 participants | 687 participants |
| Region of Enrollment United States | 444 participants | 491 participants | 935 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 444 Participants | 491 Participants | 935 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 444 | 0 / 491 |
| serious Total, serious adverse events | 0 / 444 | 0 / 491 |
Outcome results
Primary
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.
Time frame: Measured at baseline and 3 month follow-up
Population: In SOLVE-IT at 3 months, 10 multivariate outliers were excluded based on Mahalanobis distance; in Wait-list Control 12 multivariate outliers were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOLVE-IT | Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months | .10 Res. Change in Counts of UAI at 3 months | Standard Deviation 6.67 |
| Waitlist Control | Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months | -.09 Res. Change in Counts of UAI at 3 months | Standard Deviation 9.95 |
Primary
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.
Time frame: Measured at baseline and 6 month follow-up
Population: Here we use only complete data for a given analysis. Using Mahlolanobis distance critical values 11 participants in the SOLVE-IT group and 5 participants in the Waitlist Control were multivariate outliers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOLVE-IT | Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months | -.48 Change in Counts of UAI at 6 months | Standard Deviation 3.95 |
| Waitlist Control | Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months | .41 Change in Counts of UAI at 6 months | Standard Deviation 4.68 |
p-value: <0.001t-test, 2 sided
Secondary
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.
Time frame: Measured at baseline and Immediate post
Population: At baseline 443 (of 444) SOLVE-IT and 491 WLC filled out the shame measure, but 7 per condition responded with refuse to answer. A technical glitch post-game (that affected immediate post baseline measures only) resulted in 337 participants in SOLVE-IT but 482 WLC responding to immediate post.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOLVE-IT | Shame Residualized Change | -.13 score on a scale | Standard Deviation 0.65 |
| Waitlist Control | Shame Residualized Change | .09 score on a scale | Standard Deviation 0.03 |