An interventional study of SOLVE-IT in HIV Infections, sponsored by University of Southern California. Completed at 1 site in United States. Open to male participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2019-07-16.
Sponsored by University of Southern California · Not applicable, Interventional, and Prevention
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.
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 2,020 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
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).
Behavioral: SOLVE-IT
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.
Behavioral: 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.
Also known as: Socially Optimized Learning in Virtual Environments
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
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
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
| Milestone | SOLVE-IT | Waitlist Control |
|---|---|---|
| Started | 444 | 491 |
| Completed | 294 | 334 |
| Not completed | 150 | 157 |
| Withdrew: Participant would not respond | 150 | 157 |
| Milestone | SOLVE-IT | Waitlist Control |
|---|---|---|
| Started | 444 | 491 |
| Completed | 311 | 350 |
| Not completed | 133 | 141 |
| Withdrew: Participant would not respond | 133 | 141 |
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.
| Res. Change in Counts of UAI at 3 months | SOLVE-IT | Waitlist Control |
|---|---|---|
| Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months | .10 ± 6.67 | -.09 ± 9.95 |
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.
| Change in Counts of UAI at 6 months | SOLVE-IT | Waitlist Control |
|---|---|---|
| Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months | -.48 ± 3.95 | .41 ± 4.68 |
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.
| score on a scale | SOLVE-IT | Waitlist Control |
|---|---|---|
| Shame Residualized Change | -.13 ± .65 | .09 ± .03 |
Collected over 6 months per participant in the main study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOLVE-IT | — | 0/444 (0%) | 0/444 (0%) |
| Waitlist Control | — | 0/491 (0%) | 0/491 (0%) |
| Age, Categorical(Participants) | SOLVE-IT | Waitlist Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 444 | 491 | 935 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | SOLVE-IT | Waitlist Control | Total |
|---|---|---|---|
| Mean | 21.3 ± 1.7 | 21.3 ± 1.8 | 21.3 ± 1.8 |
| Sex: Female, Male(Participants) | SOLVE-IT | Waitlist Control | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 444 | 491 | 935 |
| Race/Ethnicity, Customized(participants) | SOLVE-IT | Waitlist Control | Total |
|---|---|---|---|
| White/Caucasian | 338 | 349 | 687 |
| Latino/Hispanic | 55 | 76 | 131 |
| Black/African American | 51 | 66 | 117 |
| Region of Enrollment(participants) | SOLVE-IT | Waitlist Control | Total |
|---|---|---|---|
| United States | 444 | 491 | 935 |
| Counts of unprotected anal intercourse (UAI) past 3 months(counts) | SOLVE-IT | Waitlist Control | Total |
|---|---|---|---|
| Mean | 11.7 ± 12.5 | 12.5 ± 11.8 | 12.12 ± 12.14 |
| Level of shame(units on a scale) | SOLVE-IT | Waitlist Control | Total |
|---|---|---|---|
| Mean | 1.7 ± .77 | 1.7 ± .82 | 1.7 ± .80 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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University of Southern California