A Multilevel Gaming Intervention for Persons on PrEP

PrEP Clinical Trial

Official title:

A Multilevel Gaming Intervention for Persons on PrEP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02611362
• Other study ID #: 1R34MH104068
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2019

Study information

• Verified date: December 2020
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

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:

-

Related Conditions & MeSH terms

• HIV Risk
• MSM
• PrEP

Intervention

Behavioral:
• IMB Gaming Intervention

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

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* Note: There are 144 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	24 weeks
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).	24 weeks
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).	24 weeks
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).	24 weeks
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.	24 weeks
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.	24 weeks