- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05242952
El estudio LEARN para la prevención de ECV (LEARN)
APROVECHAR UN ENTORNO VIRTUAL (LEARN) PARA MEJORAR LA PREVENCIÓN DE COMORBILIDADES RELACIONADAS CON EL VIH EN HSH DE MINORÍAS EN RIESGO
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Connecticut
-
Orange, Connecticut, Estados Unidos, 06477
- Yale University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- identificarse como una minoría étnica/racial con VIH
- identificarse como gay, amante del mismo género o HSH
- capaz de leer y entender inglés
- acceso a una computadora capaz de descargar y ejecutar el software VE
- sin antecedentes médicos de complicaciones cardiovasculares o cognitivas graves
Criterio de exclusión:
Cualquier cosa fuera de los parámetros de inclusión, incluido el historial de:
- infarto de miocardio (IM)
- insuficiencia cardiaca congestiva (CHF)
- injerto de derivación de arteria coronaria (CABG)
- accidente vascular cerebral (ACV)
- deterioro cognitivo
Plan de estudios
¿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 |
|---|---|
|
Experimental: Grupo de Intervención Inmediata
Los participantes ingresarán a un juego en línea y aprenderán cómo prevenir afecciones cardiovasculares y metabólicas.
|
Para abordar los resultados primarios de viabilidad y aceptabilidad del VE, capturaremos los datos del proceso mediante un entorno virtual basado en computadora y medidas de autoinforme mediante una encuesta en línea.
|
|
Otro: Grupo de control de lista de espera
Los participantes ingresarán a un juego en línea en una fecha posterior después del grupo de intervención inmediata y aprenderán cómo prevenir afecciones cardiovasculares y metabólicas.
|
Para abordar los resultados primarios de viabilidad y aceptabilidad del VE, capturaremos los datos del proceso mediante un entorno virtual basado en computadora y medidas de autoinforme mediante una encuesta en línea.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility of Virtual Environment Intervention
Periodo de tiempo: Baseline through Month 6
|
Feasibility was operationalized through recruitment metrics (proportion of individuals who enrolled from those initially contacted) and retention metrics (percentage of participants who completed 3-month and 6-month follow-up assessments from baseline analysis sample).
|
Baseline through Month 6
|
|
Acceptability of Virtual Environment- Engagement
Periodo de tiempo: 6-month intervention period
|
Acceptability was evaluated through engagement with the VE measured via platform metadata and logfile analysis.
|
6-month intervention period
|
|
Acceptability of Virtual Environment- Total Sessions
Periodo de tiempo: 6-month intervention period
|
Acceptability was evaluated through total sessions logged in the VE measured via platform metadata and logfile analysis.
|
6-month intervention period
|
|
Acceptability of Virtual Environment- Mean Session Duration
Periodo de tiempo: 6-month intervention period
|
Acceptability was evaluated through mean session duration in the VE in minutes measured via platform metadata and logfile analysis.
|
6-month intervention period
|
|
Acceptability of Virtual Environment- Total Educational Quests Accessed
Periodo de tiempo: 6-month intervention period
|
Acceptability was evaluated through the total number of distinct educational quests accessed in the VE measured via platform metadata and logfile analysis.
|
6-month intervention period
|
|
Acceptability of Virtual Environment- Percent VE District Visits
Periodo de tiempo: 6-month intervention period
|
Acceptability was evaluated through the percentage of visits for each of the districts within the VE measured via platform metadata and logfile analysis.
|
6-month intervention period
|
|
Acceptability of Virtual Environment- Total Engagements Per Module
Periodo de tiempo: 6-month intervention period
|
Acceptability was evaluated through total number of engagements per module in the VE measured via platform metadata and logfile analysis.
|
6-month intervention period
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Body Mass Index (BMI)
Periodo de tiempo: Baseline and Month 3 & 6
|
Between group change from baseline in Body Mass Index (BMI) represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention. |
Baseline and Month 3 & 6
|
|
Change in Physical Activity
Periodo de tiempo: Baseline and Month 3
|
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a validated questionnaire that assesses physical activity through self-reported frequency and duration.
Walking includes any walking for work, transport, or recreation (3.3 Metabolic Equivalent of Task or METs).
Moderate-intensity activity includes activities requiring moderate effort such as carrying light loads or recreational swimming (4.0 METs).
Vigorous-intensity activity includes activities requiring hard physical effort such as running or aerobics (8.0 METs).
Total physical activity is calculated as MET-minutes per week (MET value × minutes × days).
Values are reported as minutes per week or MET-minutes per week, with a minimum of 0 and no fixed maximum.
Higher values indicate greater physical activity, which is favorable for cardiovascular health.
Between group change from baseline represented as Cohen's d effect size.
Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39;
Medium=0.40-0.69;
La
|
Baseline and Month 3
|
|
Change in Physical Activity
Periodo de tiempo: Baseline and Month 6
|
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a validated questionnaire that assesses physical activity through self-reported frequency and duration.
Walking includes any walking for work, transport, or recreation (3.3 Metabolic Equivalent of Task or METs).
Moderate-intensity activity includes activities requiring moderate effort such as carrying light loads or recreational swimming (4.0 METs).
Vigorous-intensity activity includes activities requiring hard physical effort such as running or aerobics (8.0 METs).
Total physical activity is calculated as MET-minutes per week (MET value × minutes × days).
Values are reported as minutes per week or MET-minutes per week, with a minimum of 0 and no fixed maximum.
Higher values indicate greater physical activity, which is favorable for cardiovascular health.
Between group change from baseline represented as Cohen's d effect size.
Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39;
Medium=0.40-0.69;
La
|
Baseline and Month 6
|
|
Tobacco and E-cigarette Use- Question 1
Periodo de tiempo: Baseline
|
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use.
Participants were asked: Question 1: "Have you smoked at least 100 cigarettes in your entire life?"
|
Baseline
|
|
Tobacco and E-cigarette Use- Question 2
Periodo de tiempo: Baseline
|
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use.
Participants were asked: Question 2 "Do you now smoke cigarettes every day, some days, or not at all?"
|
Baseline
|
|
Tobacco and E-cigarette Use- Question 3
Periodo de tiempo: Baseline
|
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use.
Participants were asked: Question 3: "During the past 12 months, have you stopped smoking for one day or longer because you were trying to quit smoking?"
|
Baseline
|
|
Tobacco and E-cigarette Use- Question 4
Periodo de tiempo: Baseline
|
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use.
Participants were asked: Question 4: "How long has it been since you last smoked a cigarette, even one or two puffs?"
|
Baseline
|
|
Tobacco and E-cigarette Use- Question 5
Periodo de tiempo: Baseline
|
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use.
Participants were asked: Question 5: "Do you currently use chewing tobacco, snuff, or snus every day, some days, or not at all?"
|
Baseline
|
|
Tobacco and E-cigarette Use- Question 6
Periodo de tiempo: Baseline
|
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use.
Participants were asked: Question 6: "Have you ever used an e-cigarette or other electronic "vaping" product, even just one time, in your entire life?"
|
Baseline
|
|
Tobacco and E-cigarette Use- Question 7
Periodo de tiempo: Baseline
|
Behavioral Risk Factor Surveillance System (BRFSS)- self report measure questions that pertain to Tobacco use and E-cigarette use.
Participants were asked: Question 7: "Do you now use e-cigarettes or other electronic "vaping" products every day, some days, or not at all?"
|
Baseline
|
|
Change in Nutrition Intake
Periodo de tiempo: Baseline and Month 3
|
Dietary intake was assessed using the NCI Multifactor Screener, a validated food frequency questionnaire that reports how frequently individuals consume foods in 6 categories.
Vegetables, fruit, and whole grains were measured as average daily servings; sweets, red meat, and fast food were measured as weekly servings or meals.
Values are self-reported counts with a minimum of 0 and no fixed maximum.
Adherence was evaluated against dietary guidelines recommending ≥3 servings of vegetables and ≥2.5 servings of fruit daily.
For vegetables, fruit, and whole grains, higher values indicate healthier dietary patterns (favorable).
For sweets, red meat, and fast food, lower consumption is favorable for cardiovascular health.
Between group change from baseline represented as Cohen's d effect size.
Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39;
Medium=0.40-0.69;
Large≥0.70.
Positive values are favorable for intervention; negative values are unfavorable for intervention.
|
Baseline and Month 3
|
|
Change in Nutrition Intake
Periodo de tiempo: Baseline and Month 6
|
Dietary intake was assessed using the NCI Multifactor Screener, a validated food frequency questionnaire that reports how frequently individuals consume foods in 6 categories.
Vegetables, fruit, and whole grains were measured as average daily servings; sweets, red meat, and fast food were measured as weekly servings or meals.
Values are self-reported counts with a minimum of 0 and no fixed maximum.
Adherence was evaluated against dietary guidelines recommending ≥3 servings of vegetables and ≥2.5 servings of fruit daily.
For vegetables, fruit, and whole grains, higher values indicate healthier dietary patterns (favorable).
For sweets, red meat, and fast food, lower consumption is favorable for cardiovascular health.
Between group change from baseline represented as Cohen's d effect size.
Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39;
Medium=0.40-0.69;
Large≥0.70.
Positive values are favorable for intervention; negative values are unfavorable for intervention.
|
Baseline and Month 6
|
|
Change in Psychosocial Wellbeing
Periodo de tiempo: Baseline and Month 3 & 6
|
The Patient Health Questionnaire-9 (PHQ-9) is a validated 9-item questionnaire used to screen for depression.
Each item is scored 0-3, with total scores ranging from 0 to 27.
Severity categories: minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27).
Higher scores indicate greater severity of depressive symptoms (unfavorable).
Between group change from baseline represented as Cohen's d effect size.
Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39;
Medium=0.40-0.69;
Large≥0.70.
Positive values are favorable for intervention; negative values are unfavorable for intervention.
|
Baseline and Month 3 & 6
|
|
Change in Revised Illness Perceptions Questionnaire
Periodo de tiempo: Baseline and Month 3
|
Assesses cognitive and emotional representations of illness using 5-point Likert scales (1 = strongly disagree, 5 = strongly agree).
Subscale scores are calculated as sum totals with the following ranges: Timeline Acute/Chronic (3-15), Timeline Cyclical (4-20), Consequences (5-25), Personal Control (4-20), Treatment Control (4-20), Illness Coherence (4-20), and Emotional Representations (6-30).
Higher scores indicate stronger beliefs in each domain.
For Personal Control, Treatment Control, and Illness Coherence, higher scores indicate more adaptive beliefs (favorable).
For Consequences and Emotional Representations, higher scores indicate more negative perceptions (unfavorable).
Between group change from baseline represented as Cohen's d effect size.
Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39;
Medium=0.40-0.69;
Large≥0.70.
Positive values are favorable for intervention; negative values are unfavorable for intervention.
|
Baseline and Month 3
|
|
Change in Revised Illness Perceptions Questionnaire
Periodo de tiempo: Baseline and Month 6
|
The Revised Illness Perception Questionnaire was used to assess perceptions about hypertension and diabetes on a 5-point Likert scale ("strongly disagree" to "strongly agree") over 8 dimensions. Between group change from baseline represented as Cohen's d effect size. Effect Size Interpretation: Negligible < 0.20; Small=0.20-0.39; Medium=0.40-0.69; Large≥0.70. Positive values are favorable for intervention; negative values are unfavorable for intervention. |
Baseline and Month 6
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Yale University School of Nursing
Publicaciones y enlaces útiles
Publicaciones Generales
- Ramos SR, Warren R, Shedlin M, Melkus G, Kershaw T, Vorderstrasse A. A Framework for Using eHealth Interventions to Overcome Medical Mistrust Among Sexual Minority Men of Color Living with Chronic Conditions. Behav Med. 2019 Apr-Jun;45(2):166-176. doi: 10.1080/08964289.2019.1570074.
- Ramos SR, O'Hare OM, Hernandez Colon A, Kaplan Jacobs S, Campbell B, Kershaw T, Vorderstrasse A, Reynolds HR. Purely Behavioral: A Scoping Review of Nonpharmacological Behavioral and Lifestyle Interventions to Prevent Cardiovascular Disease in Persons Living With HIV. J Assoc Nurses AIDS Care. 2021 Sep-Oct 01;32(5):536-547. doi: 10.1097/JNC.0000000000000230.
- Ramos SR, Johnson C, Melkus G, Kershaw T, Gwadz M, Reynolds H, Vorderstrasse A. Cardiovascular Disease Prevention Education Using a Virtual Environment in Sexual-Minority Men of Color With HIV: Protocol for a Sequential, Mixed Method, Waitlist Randomized Controlled Trial. JMIR Res Protoc. 2022 May 17;11(5):e38348. doi: 10.2196/38348.
- Ramos SR, Reynolds H, Johnson C, Melkus G, Kershaw T, Thayer JF, Vorderstrasse A. Perceptions of HIV-Related Comorbidities and Usability of a Virtual Environment for Cardiovascular Disease Prevention Education in Sexual Minority Men With HIV: Formative Phases of a Pilot Randomized Controlled Trial. J Med Internet Res. 2024 Aug 22;26:e57351. doi: 10.2196/57351.
- Ramos SR, Boerger L, Restar AJ, Phadke M, Jeon S, Johnson C, Melkus G, Kershaw T, Reynolds H, Vorderstrasse A. A Web-Based Virtual Environment Behavioral Intervention as Cardiovascular Disease and Metabolic Disease Prevention Education in Persons With HIV: Evaluation of the LEARN Randomized Controlled Trial. J Med Internet Res. 2026 Jun 15;28:e91145. doi: 10.2196/91145.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones transmitidas por la sangre
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema inmunológico
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Comportamiento
- Comportamiento Sexual
- Infecciones por VIH
- Enfermedades cardiovasculares
- Coito
Otros números de identificación del estudio
- 2000031403
- 1K01HL145580-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los 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. .