- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05242952
L'étude LEARN pour la prévention des MCV (LEARN)
UTILISER UN ENVIRONNEMENT VIRTUEL (LEARN) pour améliorer la prévention des comorbidités liées au VIH chez les HSH appartenant à des minorités à risque
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Connecticut
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Orange, Connecticut, États-Unis, 06477
- Yale University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
Critère d'intégration:
- s'identifier comme une minorité ethnique/raciale vivant avec le VIH
- s'identifier comme gay, homosexuel ou HSH
- capable de lire et de comprendre l'anglais
- accès à un ordinateur capable de télécharger et d'exécuter le logiciel VE
- aucun antécédent médical de complications cardiovasculaires ou cognitives graves
Critère d'exclusion:
Tout élément en dehors des paramètres d'inclusion, y compris l'historique de :
- infarctus du myocarde (IM)
- insuffisance cardiaque congestive (CHF)
- pontage aortocoronarien (CABG)
- accident vasculaire cérébral (AVC)
- déficience cognitive
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Groupe d'intervention immédiate
Les participants entreront dans un jeu en ligne et apprendront comment prévenir les maladies cardiovasculaires et métaboliques.
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Pour répondre aux principaux résultats de faisabilité et d'acceptabilité de l'EV, nous recueillerons des données de processus à l'aide d'un environnement virtuel informatisé et des mesures d'auto-évaluation à l'aide d'un sondage en ligne.
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Autre: Groupe de contrôle de la liste d'attente
Les participants participeront à un jeu en ligne à une date ultérieure après le groupe d'intervention immédiate et apprendront comment prévenir les maladies cardiovasculaires et métaboliques.
|
Pour répondre aux principaux résultats de faisabilité et d'acceptabilité de l'EV, nous recueillerons des données de processus à l'aide d'un environnement virtuel informatisé et des mesures d'auto-évaluation à l'aide d'un sondage en ligne.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility of Virtual Environment Intervention
Délai: Baseline through Month 6
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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).
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Baseline through Month 6
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Acceptability of Virtual Environment- Engagement
Délai: 6-month intervention period
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Acceptability was evaluated through engagement with the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Total Sessions
Délai: 6-month intervention period
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Acceptability was evaluated through total sessions logged in the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Mean Session Duration
Délai: 6-month intervention period
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Acceptability was evaluated through mean session duration in the VE in minutes measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Total Educational Quests Accessed
Délai: 6-month intervention period
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Acceptability was evaluated through the total number of distinct educational quests accessed in the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Percent VE District Visits
Délai: 6-month intervention period
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Acceptability was evaluated through the percentage of visits for each of the districts within the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Acceptability of Virtual Environment- Total Engagements Per Module
Délai: 6-month intervention period
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Acceptability was evaluated through total number of engagements per module in the VE measured via platform metadata and logfile analysis.
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6-month intervention period
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Body Mass Index (BMI)
Délai: 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
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Change in Physical Activity
Délai: Baseline and Month 3
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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
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Baseline and Month 3
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Change in Physical Activity
Délai: 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
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Baseline and Month 6
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Tobacco and E-cigarette Use- Question 1
Délai: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 2
Délai: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 3
Délai: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 4
Délai: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 5
Délai: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 6
Délai: Baseline
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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?"
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Baseline
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Tobacco and E-cigarette Use- Question 7
Délai: 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?"
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Baseline
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Change in Nutrition Intake
Délai: Baseline and Month 3
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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.
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Baseline and Month 3
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Change in Nutrition Intake
Délai: Baseline and Month 6
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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.
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Baseline and Month 6
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Change in Psychosocial Wellbeing
Délai: Baseline and Month 3 & 6
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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.
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Baseline and Month 3 & 6
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Change in Revised Illness Perceptions Questionnaire
Délai: Baseline and Month 3
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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.
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Baseline and Month 3
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Change in Revised Illness Perceptions Questionnaire
Délai: Baseline and Month 6
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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
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: S. Raquel Ramos, PhD, MBA, MSN, FNP-BC, Yale University School of Nursing
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections transmissibles par le sang
- Maladies urogénitales
- Maladies génitales
- Maladies du système immunitaire
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Comportement
- Comportement sexuel
- Infections à VIH
- Maladies cardiovasculaires
- Coït
Autres numéros d'identification d'étude
- 2000031403
- 1K01HL145580-01A1 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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