Trial Outcomes & Findings for A Multilevel Gaming Intervention for Persons on PrEP (NCT NCT02611362)
NCT ID: NCT02611362
Last Updated: 2021-01-12
Results Overview
Self-report measure of adherence in the past 7 days categorized as "optimal" (0-3 missed doses in the past 7 days) versus "suboptimal" (4-7 missed doses in the past 7 days).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-01-12
Participant Flow
Participant milestones
| Measure |
Intervention
Subjects in the intervention group will each receive smartphones with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
Immediate Posttest (3 Months)
|
33
|
34
|
|
Overall Study
6-month Follow-up
|
32
|
35
|
|
Overall Study
COMPLETED
|
32
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Intervention
Subjects in the intervention group will each receive smartphones with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
Baseline Characteristics
Missing data
Baseline characteristics by cohort
| Measure |
Intervention
n=41 Participants
The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
n=41 Participants
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.8 years
STANDARD_DEVIATION 4.4 • n=41 Participants
|
24.8 years
STANDARD_DEVIATION 3.9 • n=41 Participants
|
24.8 years
STANDARD_DEVIATION 4.1 • n=82 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=40 Participants • Missing data
|
3 Participants
n=41 Participants • Missing data
|
3 Participants
n=81 Participants • Missing data
|
|
Sex: Female, Male
Male
|
40 Participants
n=40 Participants • Missing data
|
38 Participants
n=41 Participants • Missing data
|
78 Participants
n=81 Participants • Missing data
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=41 Participants
|
39 Participants
n=41 Participants
|
78 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=41 Participants
|
36 Participants
n=41 Participants
|
70 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=41 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=41 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=82 Participants
|
|
Insurance Type
None
|
8 Participants
n=40 Participants • Missing data
|
8 Participants
n=41 Participants • Missing data
|
16 Participants
n=81 Participants • Missing data
|
|
Insurance Type
Public
|
10 Participants
n=40 Participants • Missing data
|
11 Participants
n=41 Participants • Missing data
|
21 Participants
n=81 Participants • Missing data
|
|
Insurance Type
Private
|
22 Participants
n=40 Participants • Missing data
|
22 Participants
n=41 Participants • Missing data
|
44 Participants
n=81 Participants • Missing data
|
|
Time on PrEP
Less than one month
|
9 Participants
n=41 Participants
|
6 Participants
n=41 Participants
|
15 Participants
n=82 Participants
|
|
Time on PrEP
One month or more
|
32 Participants
n=41 Participants
|
35 Participants
n=41 Participants
|
67 Participants
n=82 Participants
|
|
Sexual Orientation
Heterosexual
|
1 Participants
n=41 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=82 Participants
|
|
Sexual Orientation
Homosexual
|
27 Participants
n=41 Participants
|
29 Participants
n=41 Participants
|
56 Participants
n=82 Participants
|
|
Sexual Orientation
Bisexual
|
13 Participants
n=41 Participants
|
12 Participants
n=41 Participants
|
25 Participants
n=82 Participants
|
|
Health Literacy
Never
|
26 Participants
n=41 Participants
|
32 Participants
n=41 Participants
|
58 Participants
n=82 Participants
|
|
Health Literacy
Rarely
|
11 Participants
n=41 Participants
|
6 Participants
n=41 Participants
|
17 Participants
n=82 Participants
|
|
Health Literacy
Sometimes
|
4 Participants
n=41 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=82 Participants
|
|
Health Literacy
Often
|
0 Participants
n=41 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=82 Participants
|
|
Health Literacy
Always
|
0 Participants
n=41 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=82 Participants
|
|
Global Severity Index
|
0.5 units on a scale
STANDARD_DEVIATION 0.8 • n=41 Participants
|
0.3 units on a scale
STANDARD_DEVIATION 0.8 • n=41 Participants
|
0.4 units on a scale
STANDARD_DEVIATION 0.8 • n=82 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Loss to follow-up, withdrawals, and missing data account for the discrepancy in the analysis population.
Self-report measure of adherence in the past 7 days categorized as "optimal" (0-3 missed doses in the past 7 days) versus "suboptimal" (4-7 missed doses in the past 7 days).
Outcome measures
| Measure |
Intervention
n=31 Participants
Subjects in the intervention group will each receive a smartphone with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
n=34 Participants
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
|---|---|---|
|
Self-Report of PrEP Adherence
Optimal adherence
|
22 Participants
|
26 Participants
|
|
Self-Report of PrEP Adherence
Suboptimal adherence
|
9 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Missing data, withdrawals, and those lost to follow-up account for the discrepancy in the analysis population.
Intracellular TFV-DP will be measured in red blood cells using dried blood spots. TFV-DP levels provide a measure of long-term adherence over the preceding month (like hemoglobin A1C). The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average (e.g. 7/wk on average, 4-7/wk on average, 2-4/wk on average, \<2/wk on average).
Outcome measures
| Measure |
Intervention
n=27 Participants
Subjects in the intervention group will each receive a smartphone with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
n=28 Participants
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
|---|---|---|
|
ARV (TFV-DP) Levels
|
810.4 fmol/punch
Standard Deviation 662.6
|
574.6 fmol/punch
Standard Deviation 668.9
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Missing data, withdrawals, and those lost to follow-up account for the discrepancy in the analysis population.
The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average in the past month (e.g. 7/wk on average, 4-7/wk on average, 2-4/wk on average, \<2/wk on average).
Outcome measures
| Measure |
Intervention
n=27 Participants
Subjects in the intervention group will each receive a smartphone with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
n=28 Participants
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
|---|---|---|
|
Average Number of Days on PrEP Per Week
Undetectable levels
|
5 Participants
|
6 Participants
|
|
Average Number of Days on PrEP Per Week
Less than 2 days (<350 fmol/punch)
|
4 Participants
|
7 Participants
|
|
Average Number of Days on PrEP Per Week
2-3 days (350-699 fmol/punch)
|
3 Participants
|
8 Participants
|
|
Average Number of Days on PrEP Per Week
4-6 days (700-1249 fmol/punch)
|
7 Participants
|
2 Participants
|
|
Average Number of Days on PrEP Per Week
7 days (greater than or equal to 1250 fmol/punch)
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Missing data, withdrawals, and loss to follow-up account for the discrepancy in the analysis population.
The HIV Knowledge Scale assesses knowledge about issues such as risks for HIV, using 5 items with "true," "false," or "do not know" response options. Total scores range from 0 to 5. Higher scores indicate greater knowledge.
Outcome measures
| Measure |
Intervention
n=31 Participants
Subjects in the intervention group will each receive a smartphone with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
n=34 Participants
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
|---|---|---|
|
HIV Knowledge at 24 Weeks
|
4.1 units on a scale
Standard Deviation 1.1
|
4.2 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Missing data, withdrawals and loss to follow-up account for the discrepancy in the analysis population.
Rollnick's Readiness Ruler will be used to assess motivation for adherence to medication and medical visits. Respondents rate how ready they are to take PrEP as prescribed on a scale from 1 (not ready) to 10 (ready to be consistent or already consistent) each month.
Outcome measures
| Measure |
Intervention
n=31 Participants
Subjects in the intervention group will each receive a smartphone with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
n=34 Participants
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
|---|---|---|
|
Motivational Readiness for Adherence at 24 Weeks
|
9.1 units on a scale
Standard Deviation 2.4
|
9.8 units on a scale
Standard Deviation 0.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksPopulation: Missing data, withdrawals and loss to follow-up accounts for the discrepancy in the analysis population.
This six item measure assesses social support for taking medications, going to medical appointments and other tasks related to adherence using Likert style items with a four point scale. Scores range from 6 to 24 Higher scores indicate greater social support.
Outcome measures
| Measure |
Intervention
n=31 Participants
Subjects in the intervention group will each receive a smartphone with a data service plan. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic.
IMB Gaming Intervention
|
Comparison
n=34 Participants
This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).
|
|---|---|---|
|
Social Support for Medication Adherence
|
21.4 units on a scale
Standard Deviation 3.9
|
21.2 units on a scale
Standard Deviation 5.4
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Comparison
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place