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A Multilevel Gaming Intervention for Persons on PrEP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02611362
Recruitment Status : Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : March 19, 2019
Information provided by (Responsible Party):
Laura Whiteley, Rhode Island Hospital

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 that is connected to smart, electronic pill organizer/dispenser. Data on adherence from the pill dispenser will be integrated into the app/game wirelessly and will translate into enhancements during game play. 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.

Condition or disease Intervention/treatment Phase
MSM PrEP HIV Risk Behavioral: IMB Gaming Intervention Not Applicable

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 a multi-level technology that integrates a medication monitoring device (Wisepill dispenser) WITH 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). Adherence data from participants' Wisepill device will be integrated into the app/game wirelessly and will translate into enhancements during game play. 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 (integration of the Wisepill dispenser with the 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 (that integrates the electronic, portable medication dispenser and the IMB game, Viral Combat) 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 that integrates the electronic medication dispenser and the IMB informed app/game compared to a time, attention, and technology matched group. We will examine the impact of the IMB Gaming Intervention in improving treatment adherence (measured by medication dispenser openings, clinic visits attended, self-report) and biological measures (ARV levels). We will also examine the impact on HIV risk behaviors.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multilevel Gaming Intervention for Persons on PrEP
Actual Study Start Date : April 2015
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 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. Wisepill openings translate into enhanced game play (i.e. "nanobucks" used to buy game enhancements). Participants will be told to take PrEP daily and phones and software will be coded to record and react to daily dosing. If a participant misses a dose, a message is sent from the Wisepill dispenser to study investigators' database on a secure server. 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.
Behavioral: IMB Gaming Intervention
No 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, ). 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. Participants will also receive a Wisepill device, which records pill dispenser openings, but there will be no dose related game enhancement or messaging. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care).

Primary Outcome Measures :
  1. Wisepill openings [ Time Frame: Daily ]
    From date of baseline through study completion, an average of up to 24 weeks.

Secondary Outcome Measures :
  1. Self-Report of PrEP Adherence [ Time Frame: Baseline, 12 and 24 weeks ]
  2. ARV (TFV-DP and FTC-TP) Levels [ Time Frame: Baseline, 12 and 24 weeks ]
    Intracellular TFV-DP and FTC-TP 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) and a detectable FTC-TP provides information about recent dosing (i.e. if FTC-TP is detectable, a recent dose was ingested Y/N). The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average (eg 7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average). 25µL will be drawn each time.

  3. The Risk Behavior Assessment [ Time Frame: Baseline, 12 and 24 weeks ]
    The RBA is a reliable and valid computer-assisted structured interview assessing self-reported sexual behaviors. It assesses type of sexual behavior (i.e., anal, oral, vaginal) in the past 12 weeks, frequency of sex, and number and gender of partners. Additional questions cover sex with high-risk partners, frequency and quantity of substance use and having sex while using alcohol/drugs.

  4. HIV and STI Knowledge [ Time Frame: Baseline, 12 and 24 weeks ]
    The HIV Knowledge Scale assesses knowledge about issues such as risks for HIV, using 18 items with "true," "false," or "do not know" response options.

  5. Attitudes towards adherence [ Time Frame: Baseline, 12 and 24 weeks ]
    This checklist was from attitude items used from several AIDS Clinical Trials Groups and will be modified to reflect adherence to a medication to prevent HIV. The checklist assesses 16 common barriers to taking ARV as prescribed and 10 aids to taking ARV.

  6. Motivational Readiness for Adherence [ Time Frame: Baseline, 12 and 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 and to keep medical appointments on two items from 1 (not ready) to 10 (ready to be consistent or already consistent) each month. Subjects will also complete the 10 item Likert-style IMB PrEP Motivation Scale from the LifeWindows Project Team. It will be modified to assess personal and social motivations for PrEP, rather than ART

  7. Medication and Appointment Self-Efficacy [ Time Frame: Baseline, 12 and 24 weeks ]
    The instrument consists of Likert style items (with five response options). Three items assess self efficacy for taking medication as prescribed and three items assess self efficacy for adherence to medical appointments

Other Outcome Measures:
  1. Relationship with Providers [ Time Frame: Baseline, 12 and 24 weeks ]
    This five item measure assesses the perceived relationship with health care providers using Likert type items suggested by an ART adherence intervention with adults

  2. Social Support for Medication Adherence [ Time Frame: Baseline, 12 and 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.

  3. Brief Symptom Inventory [ Time Frame: Baseline, 12 and 24 weeks ]
    Mental health issues will be assessed by the Brief Symptom Inventory (BSI), which requires only eight to ten minutes in which to complete. It yields nine primary symptom scales and global indices and has norms for adolescents and adults.

  4. The Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST V2.0) [ Time Frame: Baseline, 12 and 24 weeks ]
    The ASSIST is an eight item questionnaire that screens for all levels of problem substance use. The instrument covers tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants (including ecstasy), inhalants, sedatives, hallucinogens, opioids and "other drugs."

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts 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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02611362

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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital

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Responsible Party: Laura Whiteley, Co-Director, Young Adult Behavioral Health, Rhode Island Hospital Identifier: NCT02611362     History of Changes
Other Study ID Numbers: 1R34MH104068 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019