A Multilevel Gaming Intervention for Persons on PrEP
17 de diciembre de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
82
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Masculino
Descripción
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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Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-Report of PrEP Adherence
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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HIV Knowledge at 24 Weeks
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Social Support for Medication Adherence
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Laura Whiteley, MD, Brown University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2015
Finalización primaria (Actual)
1 de noviembre de 2018
Finalización del estudio (Actual)
1 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
3 de noviembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
19 de noviembre de 2015
Publicado por primera vez (Estimar)
20 de noviembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
17 de diciembre de 2020
Última verificación
1 de diciembre de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1R34MH104068 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .