- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00653991
The SOLVE-IT National Randomized Trial (SOLVE-IT)
SOLVE IT: Real Risk Reduction for MSM
Aperçu de l'étude
Description détaillée
HIV and sexually transmitted diseases (STDs) are a major public health concern worldwide. Although prevalent across all groups of people, HIV/STDs have had a remarkable effect on men who have sex with men (MSM), who accounted for 71% of all HIV infections among American males in 2005. After years of decline, the number of HIV diagnoses appears to have increased for MSM, especially within the black MSM population. Thus, new approaches geared for HIV prevention and education and built on past HIV prevention methods are needed. New technologies, such as interactive computer games, delivered in a modern and appealing manner may gain or recapture the attention of MSM who have disregarded more traditional HIV prevention and educational services. Socially Optimized Learning in a Virtual Environment (SOLVE)-IT is an interactive virtual environment computer game, designed specifically for MSMs, that simulates the emotional, interpersonal, and contextual narrative of an actual sexual encounter and provides challenging decision-making opportunities. By promoting development of self-regulatory and behavioral skills, SOLVE-IT may be an effective approach to reduce sexual risk behaviors. This study will evaluate the effectiveness of SOLVE-IT in reducing risky sexual behaviors among MSM.
Participation in this study will last 6 months from the beginning of treatment. All participants will first undergo baseline assessments that will include questionnaires about sexual behavior, drug use, health history, feelings, and beliefs. Participants will then be assigned randomly to receive SOLVE-IT immediately or after a 6-month waitlist period. SOLVE-IT will include two 1-hour sessions conducted on a computer over the Internet, occurring at baseline and 6 months later. During sessions, participants will play an interactive computer game that presents dating or sexual scenarios and allows participants to choose how the scenarios unfold. Participants will repeat baseline questionnaires at Months 3 and 6 of follow-up. Participants in the waitlist group will be offered to receive SOLVE-IT after completion of the Month 6 follow-up.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90007
- University of Southern California (University Village)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Self-identifies as Latino, black, or Caucasian
- Men who have sex with men
- Not HIV infected
- Engaged in unprotected anal sex at least twice in the 90 days before study entry with a nonprimary male partner
- Has broadband access during course of study
- Lives in United States
- Biological male
Exclusion Criteria:
- History of nonprescription drug injection use
- Has participated in SOLVE-IT at any phase
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: SOLVE-IT
Participants will receive the intervention SOLVE-IT.
The SOLVE-IT intervention is a videogame designed to optimize self-regulation, reduce shame, and reduce risky choices for young men who have sex with men (YMSM).
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SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM.
Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context.
Autres noms:
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Comparateur actif: Waitlist Control
Participants will receive the intervention, SOLVE-IT, a video game designed to optimize self-regulation reduce shame, and reduce risky sexual choices for YMSM, after a 6-month waitlist period.
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SOLVE-IT, a video game using computer-generated virtual agents, is the next generation of interactive media aimed at reducing risky sex among young MSM.
Participants will interact in a virtual environment that focuses upon HIV prevention in a dating context.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Residualized Change in Counts of Unprotected Anal Intercourse at 3 Months
Délai: Measured at baseline and 3 month follow-up
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Counts of unprotected anal intercourse (one each for insertive and receptive; UAI) in the past 3 months with a non-primary partner were reported by participants at baseline, and 3 month follow-up.
Reports of insertive and receptive anal intercourse per time period were summed.
Change in unprotected anal intercourse was calculated at 3 months using residualized change scores (regressing 3-month reported UAI (Y) on baseline UAI.
Negative numbers reflect a reduction in UAI over time).
Although raw counts of UAI are heavily tailed, residualized change scores yield a normal distribution.
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Measured at baseline and 3 month follow-up
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Residualized Change in Counts of Unprotected Anal Intercourse at 6 Months
Délai: Measured at baseline and 6 month follow-up
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Counts of unprotected anal intercourse (one each for insertive and receptive) in the past 3 months with a non-primary partner were reported by participants at baseline, and 6 month follow-up.
Reports of insertive and receptive anal intercourse per time period were summed.
Change in unprotected anal intercourse from baseline, was calculated at 6 months using residualized change scores (regressing 6-month reported UAI (Y) on baseline UAI.
Negative numbers reflect a reduction in UAI over time).
Raw counts of UAI are heavily tailed, but residualized change scores are normally distributed.
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Measured at baseline and 6 month follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Shame Residualized Change
Délai: Measured at baseline and Immediate post
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Measures of reported shame (five items from an existing subscale of Watson and Clark's (1994) Positive and Negative Affect Schedule- Expanded Form-- designed to assess State Shame): ashamed, blameworthy, angry at self, disgusted with self, dissatisfied with self.
Participants indicate to what extent they experienced emotions that were part of this sub scale, responding on a scale from 1 (very slightly or not at all) to 5(extremely).
Values reported represent the mean value per participant on the State Shame subscale; values per participant on this subscale therefore ranged from 1 to 5. Higher scores represent a higher level of reported state shame.
Scores on this scale are heavily tailed.
Therefore, we have consistently used residualized change scores: This is calculated from baseline to immediate post; negative numbers for residualized change mean reduced shame baseline to immediate post.
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Measured at baseline and Immediate post
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Lynn C. Miller, PhD, University of Southern California
Publications et liens utiles
Publications générales
- Read SJ, Miller, LC, Appleby PR, Nwosu ME, Reynaldo S, Lauren A, Putcha A. Socially optimized learning in a virtual environment: Reducing risky sexual behavior among men who have sex with men. Human Communication Research 32(1):1-34, 2006.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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 par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies sexuellement transmissibles, virales
- Maladies sexuellement transmissibles
- Infections à lentivirus
- Infections à rétroviridae
- Syndromes d'immunodéficience
- Maladies du système immunitaire
- Infections à VIH
Autres numéros d'identification d'étude
- R01MH082671 (Subvention/contrat des NIH des États-Unis)
- DAHBR 9A-ASPQ (NIMH)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Infections à VIH
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Icahn School of Medicine at Mount SinaiIRRASRecrutementHémorragie intraventriculaire (HIV)États-Unis
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Yale UniversityComplétéPrématurité | Nourrissons de très faible poids à la naissance | Hémorragie intraventriculaire (HIV) | Saignement dans le cerveauÉtats-Unis
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West Virginia UniversityInscription sur invitationInfection de la peau et des tissus mous | Infection gastro-intestinale | Infection pulmonaire | Infection des os et des articulations | Infection endovasculaire | Infection génito-urinaireÉtats-Unis
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Radboud University Medical CenterSint MaartenskliniekActif, ne recrute pasInfection du site opératoire | Infection articulaire | Infection, site chirurgical | Prothèse Infection Hanche et Genou | Infection liée aux prothèses | InfectionProPays-Bas
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Croydon Health Services NHS TrustComplétéInfection du site opératoire | Infection de la plaie | Césarienne; Infection | Infection périnéaleRoyaume-Uni
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Taipei Medical University WanFang HospitalInconnue
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Ondine Biomedical Inc.ComplétéInfection du site opératoire | Infection nosocomiale | Infection associée aux soins de santéÉtats-Unis
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Angela BiancoStryker NordicRésiliéCésarienne | Infection du site opératoire | Infection nosocomialeÉtats-Unis
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Leiden University Medical CenterRadboud University Medical Center; University Medical Center Groningen; Erasmus... et autres collaborateursRecrutementInfection prothétique-articulaire | Infection de la hanche | Infection; Genou, ArticulationPays-Bas
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Cairo UniversityRecrutementInfection postopératoire | Complications de la césarienne | Infection vaginaleEgypte
Essais cliniques sur SOLVE-IT
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Philips Clinical & Medical Affairs GlobalComplétéMalaise de l'artère périphérique | Ischémie critique des membresL'Autriche
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University of Texas at AustinBaylor College of Medicine; University of Kansas Medical CenterComplété
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Oslo University HospitalCentre for Appearance Research, University of the West of England, UKInscription sur invitationBrûlures | Fente labiale et palatine | Anomalies craniofaciales | Condition de la peau | Autres conditions entraînant une différence visibleNorvège
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Integro TheranosticsRecrutementCancer du sein | CCIS | Carcinome canalaire invasif du seinÉtats-Unis
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ShireComplétéSyndrome de chasseurÉtats-Unis, Royaume-Uni
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Penn State UniversityComplétéProblème de toxicomanieÉtats-Unis
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Liverpool School of Tropical MedicineKenya Medical Research Institute; LVCT HealthPas encore de recrutementGrossesse | Systèmes de santé | Systèmes électroniques d'information sur la santé communautaire | Utilisation des cliniques prénatales
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Oregon Health and Science UniversityTexas A&M University; University of North Carolina, GreensboroActif, ne recrute pasActivité physiqueÉtats-Unis
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University of ChicagoNational Alliance for Research on Schizophrenia and DepressionComplété
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Peking University Third HospitalRecrutement