Trial Outcomes & Findings for The SOLVE-IT National Randomized Trial (NCT NCT00653991)
NCT ID: NCT00653991
Last Updated: 2019-07-16
Results Overview
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.
COMPLETED
NA
2020 participants
Measured at baseline and 3 month follow-up
2019-07-16
Participant Flow
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
3 Month Follow-up
STARTED
|
444
|
491
|
|
3 Month Follow-up
COMPLETED
|
294
|
334
|
|
3 Month Follow-up
NOT COMPLETED
|
150
|
157
|
|
6 Month Follow-up
STARTED
|
444
|
491
|
|
6 Month Follow-up
COMPLETED
|
311
|
350
|
|
6 Month Follow-up
NOT COMPLETED
|
133
|
141
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
3 Month Follow-up
Participant would not respond
|
150
|
157
|
|
6 Month Follow-up
Participant would not respond
|
133
|
141
|
Baseline Characteristics
The SOLVE-IT National Randomized Trial
Baseline characteristics by cohort
| Measure |
SOLVE-IT
n=444 Participants
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.
|
Waitlist Control
n=491 Participants
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.
|
Total
n=935 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
444 Participants
n=5 Participants
|
491 Participants
n=7 Participants
|
935 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.3 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
21.3 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
21.3 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
444 Participants
n=5 Participants
|
491 Participants
n=7 Participants
|
935 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
338 participants
n=5 Participants
|
349 participants
n=7 Participants
|
687 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
55 participants
n=5 Participants
|
76 participants
n=7 Participants
|
131 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
51 participants
n=5 Participants
|
66 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
444 participants
n=5 Participants
|
491 participants
n=7 Participants
|
935 participants
n=5 Participants
|
|
Counts of unprotected anal intercourse (UAI) past 3 months
|
11.7 counts
STANDARD_DEVIATION 12.5 • n=5 Participants
|
12.5 counts
STANDARD_DEVIATION 11.8 • n=7 Participants
|
12.12 counts
STANDARD_DEVIATION 12.14 • n=5 Participants
|
|
Level of shame
|
1.7 units on a scale
STANDARD_DEVIATION .77 • n=5 Participants
|
1.7 units on a scale
STANDARD_DEVIATION .82 • n=7 Participants
|
1.7 units on a scale
STANDARD_DEVIATION .80 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at baseline and 3 month follow-upPopulation: In SOLVE-IT at 3 months, 10 multivariate outliers were excluded based on Mahalanobis distance; in Wait-list Control 12 multivariate outliers were excluded.
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.
Outcome measures
| Measure |
SOLVE-IT
n=284 Participants
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.
|
Waitlist Control
n=322 Participants
After a 3-month waitlist period, participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for 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.
|
|---|---|---|
|
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
|
-.09 Res. Change in Counts of UAI at 3 months
Standard Deviation 9.95
|
PRIMARY outcome
Timeframe: Measured at baseline and 6 month follow-upPopulation: 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.
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.
Outcome measures
| Measure |
SOLVE-IT
n=300 Participants
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.
|
Waitlist Control
n=345 Participants
After a 3-month waitlist period, participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for 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.
|
|---|---|---|
|
Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months
|
-.48 Change in Counts of UAI at 6 months
Standard Deviation 3.95
|
.41 Change in Counts of UAI at 6 months
Standard Deviation 4.68
|
SECONDARY outcome
Timeframe: Measured at baseline and Immediate postPopulation: 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.
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.
Outcome measures
| Measure |
SOLVE-IT
n=337 Participants
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.
|
Waitlist Control
n=482 Participants
After a 3-month waitlist period, participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for 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.
|
|---|---|---|
|
Shame Residualized Change
|
-.13 score on a scale
Standard Deviation .65
|
.09 score on a scale
Standard Deviation .03
|
Adverse Events
SOLVE-IT
Waitlist Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Professor Lynn Carol Miller
Annenberg School for Communication and Journalism, University of Southern California
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place