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A Multilevel Gaming Intervention for Persons on PrEP

A Multilevel Gaming Intervention for Persons on PrEP

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02611362
Enrollment
82
Registered
2015-11-20
Start date
2015-04-30
Completion date
2019-12-31
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Risk, MSM, PrEP

Brief summary

This study will develop and test a novel, smartphone based gaming intervention to improve adherence to medication to prevent HIV (known as Pre-exposure Prophylaxis, PrEP) and to decrease HIV risk behaviors among men who have sex with men (MSM). In the intervention, participants will engage with an immersive app/game on their iPhone. While gaming, participants will gain information about their health, improve motivation for PrEP and medical appointment adherence, and practice healthy behaviors. If the intervention is found to be effective, it can be tested in a larger study and then disseminated to other people taking PrEP.

Detailed description

The use of antiretroviral medications to reduce the risk of acquiring HIV infection (Pre-exposure Prophylaxis, PrEP) is an efficacious and promising new prevention strategy. In published studies, failure of PrEP was associated with poor adherence and low plasma drug levels. This indicates that optimal PrEP treatment will require behavioral interventions to promote adherence. Averting increases in risk behavior will also be essential for maintaining PrEP's protective effects. Interventions will need to address on-going HIV risk behavior and be relevant for persons using PrEP (e.g. young adult MSM). Borrowing from recent literature in HIV prevention and treatment adherence, interventions that utilize intuitive easy to use technologies with motivational components show promise for behavior change and dissemination. This study will examine an interactive smartphone based app/game that is immersive and appealing. This novel, but intuitive multi-level technology will measure PrEP adherence, promote engagement in treatment and safe sexual behavior. The smartphone app/game will be developed to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about PrEP treatment and HIV), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners, condom self efficacy). In-depth interviews with young adults on PrEP and an open trial of the intervention will inform the development of the intervention and procedures. A small randomized controlled pilot study among 50 participants on PrEP will examine the preliminary efficacy of the intervention (IMB informed app/game). It is hypothesized that, compared to subjects in the control group, participants in the IMB Gaming Intervention will show: improved adherence to PrEP, higher blood ARV levels, decreased HIV risk behaviors, and improved self efficacy and attitudes for PrEP treatment adherence. The specific aims are: 1. To create an engaging and absorbing smartphone based app/game with content consistent with the Information-Motivation-Behavioral Skills (IMB) model to measure and improve PrEP treatment adherence and safer sex behaviors, and to receive feedback on the game's utility and acceptability from in-depth interviews with MSM (estimated mean age 27). 2. To conduct an open trial of the IMB Gaming Intervention with MSM to obtain further qualitative and quantitative information on its acceptability, and feasibility. These data will be used to modify the approach and technology as needed. 3. To evaluate, in a 24 week randomized controlled pilot study (n=50), the preliminary efficacy of the IMB Gaming Intervention compared to a time, attention, and technology matched group. Investigators will examine the impact of the IMB Gaming Intervention in improving treatment adherence (measured by clinic visits attended, self-report) and biological measures (ARV levels). Investigators will also examine the impact on HIV risk behaviors.

Interventions

BEHAVIORALIMB Gaming Intervention

Sponsors

Rhode Island Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

All males on PrEP over the age of 18 * English speaking * Receiving prophylactic antiretroviral treatment * Not enrolled in another PrEP related study * Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Self-Report of PrEP Adherence24 weeksSelf-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).
ARV (TFV-DP) Levels24 weeksIntracellular 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).
Average Number of Days on PrEP Per Week24 weeksThe 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).

Secondary

MeasureTime frameDescription
HIV Knowledge at 24 Weeks24 weeksThe 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.
Motivational Readiness for Adherence at 24 Weeks24 weeksRollnick'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.

Other

MeasureTime frameDescription
Social Support for Medication Adherence24 weeksThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
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
41
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).
41
Total82

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up24
Overall StudyWithdrawal by Subject72

Baseline characteristics

CharacteristicInterventionComparisonTotal
Age, Continuous24.8 years
STANDARD_DEVIATION 4.4
24.8 years
STANDARD_DEVIATION 3.9
24.8 years
STANDARD_DEVIATION 4.1
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants39 Participants78 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Global Severity Index0.5 units on a scale
STANDARD_DEVIATION 0.8
0.3 units on a scale
STANDARD_DEVIATION 0.8
0.4 units on a scale
STANDARD_DEVIATION 0.8
Health Literacy
Always
0 Participants0 Participants0 Participants
Health Literacy
Never
26 Participants32 Participants58 Participants
Health Literacy
Often
0 Participants0 Participants0 Participants
Health Literacy
Rarely
11 Participants6 Participants17 Participants
Health Literacy
Sometimes
4 Participants3 Participants7 Participants
Insurance Type
None
8 Participants8 Participants16 Participants
Insurance Type
Private
22 Participants22 Participants44 Participants
Insurance Type
Public
10 Participants11 Participants21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
34 Participants36 Participants70 Participants
Race (NIH/OMB)
More than one race
2 Participants1 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
4 Participants3 Participants7 Participants
Sex: Female, Male
Female
0 Participants3 Participants3 Participants
Sex: Female, Male
Male
40 Participants38 Participants78 Participants
Sexual Orientation
Bisexual
13 Participants12 Participants25 Participants
Sexual Orientation
Heterosexual
1 Participants0 Participants1 Participants
Sexual Orientation
Homosexual
27 Participants29 Participants56 Participants
Time on PrEP
Less than one month
9 Participants6 Participants15 Participants
Time on PrEP
One month or more
32 Participants35 Participants67 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 41
other
Total, other adverse events
0 / 410 / 41
serious
Total, serious adverse events
0 / 410 / 41

Outcome results

Primary

ARV (TFV-DP) Levels

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).

Time frame: 24 weeks

Population: Missing data, withdrawals, and those lost to follow-up account for the discrepancy in the analysis population.

ArmMeasureValue (MEAN)Dispersion
InterventionARV (TFV-DP) Levels810.4 fmol/punchStandard Deviation 662.6
ComparisonARV (TFV-DP) Levels574.6 fmol/punchStandard Deviation 668.9
Primary

Average Number of Days on PrEP Per Week

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).

Time frame: 24 weeks

Population: Missing data, withdrawals, and those lost to follow-up account for the discrepancy in the analysis population.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionAverage Number of Days on PrEP Per WeekLess than 2 days (<350 fmol/punch)4 Participants
InterventionAverage Number of Days on PrEP Per Week4-6 days (700-1249 fmol/punch)7 Participants
InterventionAverage Number of Days on PrEP Per Week2-3 days (350-699 fmol/punch)3 Participants
InterventionAverage Number of Days on PrEP Per Week7 days (greater than or equal to 1250 fmol/punch)8 Participants
InterventionAverage Number of Days on PrEP Per WeekUndetectable levels5 Participants
ComparisonAverage Number of Days on PrEP Per Week7 days (greater than or equal to 1250 fmol/punch)5 Participants
ComparisonAverage Number of Days on PrEP Per WeekUndetectable levels6 Participants
ComparisonAverage Number of Days on PrEP Per WeekLess than 2 days (<350 fmol/punch)7 Participants
ComparisonAverage Number of Days on PrEP Per Week2-3 days (350-699 fmol/punch)8 Participants
ComparisonAverage Number of Days on PrEP Per Week4-6 days (700-1249 fmol/punch)2 Participants
Primary

Self-Report of PrEP Adherence

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).

Time frame: 24 weeks

Population: Loss to follow-up, withdrawals, and missing data account for the discrepancy in the analysis population.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionSelf-Report of PrEP AdherenceOptimal adherence22 Participants
InterventionSelf-Report of PrEP AdherenceSuboptimal adherence9 Participants
ComparisonSelf-Report of PrEP AdherenceOptimal adherence26 Participants
ComparisonSelf-Report of PrEP AdherenceSuboptimal adherence8 Participants
Secondary

HIV Knowledge at 24 Weeks

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.

Time frame: 24 weeks

Population: Missing data, withdrawals, and loss to follow-up account for the discrepancy in the analysis population.

ArmMeasureValue (MEAN)Dispersion
InterventionHIV Knowledge at 24 Weeks4.1 units on a scaleStandard Deviation 1.1
ComparisonHIV Knowledge at 24 Weeks4.2 units on a scaleStandard Deviation 1.1
Secondary

Motivational Readiness for Adherence at 24 Weeks

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.

Time frame: 24 weeks

Population: Missing data, withdrawals and loss to follow-up account for the discrepancy in the analysis population.

ArmMeasureValue (MEAN)Dispersion
InterventionMotivational Readiness for Adherence at 24 Weeks9.1 units on a scaleStandard Deviation 2.4
ComparisonMotivational Readiness for Adherence at 24 Weeks9.8 units on a scaleStandard Deviation 0.6
Other Pre-specified

Social Support for Medication Adherence

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.

Time frame: 24 weeks

Population: Missing data, withdrawals and loss to follow-up accounts for the discrepancy in the analysis population.

ArmMeasureValue (MEAN)Dispersion
InterventionSocial Support for Medication Adherence21.4 units on a scaleStandard Deviation 3.9
ComparisonSocial Support for Medication Adherence21.2 units on a scaleStandard Deviation 5.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026