A Multilevel Gaming Intervention for Persons on PrEP
17 декабря 2020 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
82
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02903
- Rhode Island Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Мужской
Описание
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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Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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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Без вмешательства: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Self-Report of PrEP Adherence
Временное ограничение: 24 weeks
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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
Временное ограничение: 24 weeks
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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
Временное ограничение: 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
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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HIV Knowledge at 24 Weeks
Временное ограничение: 24 weeks
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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.
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24 weeks
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Motivational Readiness for Adherence at 24 Weeks
Временное ограничение: 24 weeks
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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
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Social Support for Medication Adherence
Временное ограничение: 24 weeks
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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.
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24 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Laura Whiteley, MD, Brown University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 апреля 2015 г.
Первичное завершение (Действительный)
1 ноября 2018 г.
Завершение исследования (Действительный)
1 декабря 2019 г.
Даты регистрации исследования
Первый отправленный
3 ноября 2015 г.
Впервые представлено, что соответствует критериям контроля качества
19 ноября 2015 г.
Первый опубликованный (Оценивать)
20 ноября 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
12 января 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 декабря 2020 г.
Последняя проверка
1 декабря 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 1R34MH104068 (Грант/контракт NIH США)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования ДКП
-
The University of Texas Health Science Center,...Merck Sharp & Dohme LLCЗавершенныйПерспективы внедрения ДКП | Опыт внедрения ДКП | Перспективы приверженности PrEP | Опыт соблюдения режима PrEPСоединенные Штаты
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Queen Mary University of LondonKing's College Hospital NHS Trust; The Leeds Teaching Hospitals NHS Trust; Guy's and... и другие соавторыЕще не набираютДКП | Использование ДКП | Перспективы приверженности PrEP | Опыт соблюдения режима PrEP | Equity | Community Setting
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Johns Hopkins Bloomberg School of Public HealthNational Institute of Mental Health (NIMH); Washington University School of Medicine и другие соавторыЕще не набираютИнъекционный каботегравир длительного действия для PrEP | Oral Pre-Exposure Prophylaxis (PrEP)Малави
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Georgetown UniversityWashington University School of Medicine; Johns Hopkins Bloomberg School of Public... и другие соавторыРекрутингПероральная доконтактная профилактика (ПрЭП) | Инъекционный каботегравир длительного действия для PrEPМалави
-
Thai Red Cross AIDS Research CentreMinistry of Health, ThailandЗавершенный
-
University of Colorado, DenverNational Institute of Allergy and Infectious Diseases (NIAID); San Francisco Department...ЗавершенныйМониторинг приверженности PrEPСоединенные Штаты
-
Boston Medical CenterGilead SciencesЗавершенныйPrEP для целей зачатияСоединенные Штаты
-
California State University, Dominguez HillsРекрутингВИЧ-отрицательный и еще не на PrEPСоединенные Штаты
-
Rutgers, The State University of New JerseyАктивный, не рекрутирующийМониторинг приверженности PrEPСоединенные Штаты
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Georgetown UniversityJohns Hopkins Bloomberg School of Public Health; United States Agency for International... и другие соавторыРекрутингПероральная доконтактная профилактика (ПрЭП) | Инъекционный каботегравир длительного действия для PrEPМалави
Клинические исследования IMB Gaming Intervention
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Imbria Pharmaceuticals, Inc.University of OxfordЗавершенныйДиабет 2 типа | Диабетические кардиомиопатии | HFpEF - сердечная недостаточность с сохраненной фракцией выбросаСоединенное Королевство
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Imbria Pharmaceuticals, Inc.ЗавершенныйИшемия | Ишемическая болезнь сердцаДания, Финляндия, Швеция
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Imbria Pharmaceuticals, Inc.ЗавершенныйНеобструктивная гипертрофическая кардиомиопатияСоединенные Штаты, Соединенное Королевство
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Ankara Yildirim Beyazıt UniversityРекрутингЦелиакия | Взрослые с целиакиейТурция (Туркие)
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Brigham and Women's HospitalNational Institute on Aging (NIA)ЗавершенныйРевматические заболевания | Красная волчанка, системная | Приверженность, лекарства | ПодаграСоединенные Штаты
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Imbria Pharmaceuticals, Inc.ОтозванРефрактерная стенокардияСоединенные Штаты
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Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)ЗавершенныйВИЧ | Употребление алкоголяСоединенные Штаты
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The Opole University of TechnologyЗавершенныйПожилые людиПольша
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Marmara UniversityАктивный, не рекрутирующийМенопаузальные приливыТурция (Туркие)
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The Dental Hospital of Zhejiang University School...Завершенный