HIV Risk, MSM, PrEP
Conditions
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
Sponsors
Study design
Eligibility
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
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Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Report of PrEP Adherence | 24 weeks | 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). |
| ARV (TFV-DP) Levels | 24 weeks | 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). |
| Average Number of Days on PrEP Per Week | 24 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Knowledge at 24 Weeks | 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. |
| Motivational Readiness for Adherence at 24 Weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Social Support for Medication Adherence | 24 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 2 |
Baseline characteristics
| Characteristic | Intervention | Comparison | Total |
|---|---|---|---|
| Age, Continuous | 24.8 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 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 39 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Global Severity Index | 0.5 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 Participants | 0 Participants | 0 Participants |
| Health Literacy Never | 26 Participants | 32 Participants | 58 Participants |
| Health Literacy Often | 0 Participants | 0 Participants | 0 Participants |
| Health Literacy Rarely | 11 Participants | 6 Participants | 17 Participants |
| Health Literacy Sometimes | 4 Participants | 3 Participants | 7 Participants |
| Insurance Type None | 8 Participants | 8 Participants | 16 Participants |
| Insurance Type Private | 22 Participants | 22 Participants | 44 Participants |
| Insurance Type Public | 10 Participants | 11 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 36 Participants | 70 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Male | 40 Participants | 38 Participants | 78 Participants |
| Sexual Orientation Bisexual | 13 Participants | 12 Participants | 25 Participants |
| Sexual Orientation Heterosexual | 1 Participants | 0 Participants | 1 Participants |
| Sexual Orientation Homosexual | 27 Participants | 29 Participants | 56 Participants |
| Time on PrEP Less than one month | 9 Participants | 6 Participants | 15 Participants |
| Time on PrEP One month or more | 32 Participants | 35 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | ARV (TFV-DP) Levels | 810.4 fmol/punch | Standard Deviation 662.6 |
| Comparison | ARV (TFV-DP) Levels | 574.6 fmol/punch | Standard Deviation 668.9 |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Average Number of Days on PrEP Per Week | Less than 2 days (<350 fmol/punch) | 4 Participants |
| Intervention | Average Number of Days on PrEP Per Week | 4-6 days (700-1249 fmol/punch) | 7 Participants |
| Intervention | Average Number of Days on PrEP Per Week | 2-3 days (350-699 fmol/punch) | 3 Participants |
| Intervention | Average Number of Days on PrEP Per Week | 7 days (greater than or equal to 1250 fmol/punch) | 8 Participants |
| Intervention | Average Number of Days on PrEP Per Week | Undetectable levels | 5 Participants |
| Comparison | Average Number of Days on PrEP Per Week | 7 days (greater than or equal to 1250 fmol/punch) | 5 Participants |
| Comparison | Average Number of Days on PrEP Per Week | Undetectable levels | 6 Participants |
| Comparison | Average Number of Days on PrEP Per Week | Less than 2 days (<350 fmol/punch) | 7 Participants |
| Comparison | Average Number of Days on PrEP Per Week | 2-3 days (350-699 fmol/punch) | 8 Participants |
| Comparison | Average Number of Days on PrEP Per Week | 4-6 days (700-1249 fmol/punch) | 2 Participants |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Self-Report of PrEP Adherence | Optimal adherence | 22 Participants |
| Intervention | Self-Report of PrEP Adherence | Suboptimal adherence | 9 Participants |
| Comparison | Self-Report of PrEP Adherence | Optimal adherence | 26 Participants |
| Comparison | Self-Report of PrEP Adherence | Suboptimal adherence | 8 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | HIV Knowledge at 24 Weeks | 4.1 units on a scale | Standard Deviation 1.1 |
| Comparison | HIV Knowledge at 24 Weeks | 4.2 units on a scale | Standard Deviation 1.1 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Motivational Readiness for Adherence at 24 Weeks | 9.1 units on a scale | Standard Deviation 2.4 |
| Comparison | Motivational Readiness for Adherence at 24 Weeks | 9.8 units on a scale | Standard Deviation 0.6 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Social Support for Medication Adherence | 21.4 units on a scale | Standard Deviation 3.9 |
| Comparison | Social Support for Medication Adherence | 21.2 units on a scale | Standard Deviation 5.4 |