A Multilevel Gaming Intervention for Persons on PrEP
2020년 12월 17일 업데이트: Laura Whiteley, Rhode Island Hospital
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.
연구 개요
상태
상태
완전한
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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:
- 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).
- 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.
- 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.
연구 유형
연구 유형
중재적
등록 (실제)
등록
82
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Rhode Island
-
Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
-
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
남성
설명
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:
-
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: Intervention
Subjects in the intervention group will each receive a smartphone with a data service plan as the active arm.
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.
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간섭 없음: 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).
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-Report of PrEP Adherence
기간: 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).
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24 weeks
|
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ARV (TFV-DP) Levels
기간: 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).
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24 weeks
|
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Average Number of Days on PrEP Per Week
기간: 24 weeks
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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).
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24 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
HIV Knowledge at 24 Weeks
기간: 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
|
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Motivational Readiness for Adherence at 24 Weeks
기간: 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.
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24 weeks
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Social Support for Medication Adherence
기간: 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.
|
24 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Laura Whiteley, MD, Brown University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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