{
  "FullStudy":{
    "Rank":218282,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510340",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CE 11.184"
          },
          "Organization":{
            "OrgFullName":"Centre hospitalier de l'Université de Montréal (CHUM)",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Evaluation of a Tailored Virtual Intervention to Empower Persons Living With HIV for Therapy Self-management",
          "Acronym":"HIVMediconline"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2019",
          "OverallStatus":"Suspended",
          "WhyStopped":"Changes & upgrades in informatic infrastructure of the web-based intervention.",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2019",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2020",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"December 13, 2011",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 14, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 15, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Centre hospitalier de l'Université de Montréal (CHUM)",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Fonds de la Recherche en Santé du Québec",
                "CollaboratorClass":"OTHER_GOV"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the efficacy of an online virtual intervention in optimizing adherence to antiretroviral medication intake among Persons Living with HIV (PLHIV)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "HIV"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "adherence",
              "HIV",
              "antiretroviral therapy",
              "tailored web intervention"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Supportive Care",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"234",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Web sites",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Patients assigned to this arm are given a list of Web sites where they can collect information related to their condition at their leisure."
              },{
                "ArmGroupLabel":"VIH-TAVIE",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patients assigned to this arm must follow the four interactive computer sessions",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: VIH-TAVIE"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"VIH-TAVIE",
                "InterventionDescription":"The tailored virtual intervention is composed of four interactive computer sessions hosted by a virtual nurse who engages the PLHIV in a medication-intake self-management skills-learning process.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "VIH-TAVIE"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Adherence",
                "PrimaryOutcomeDescription":"Adherence will be evaluated through a self-administered questionnaire that was developed for and validated on the targeted population (Godin, Gagné, & Naccache, 2003). The questionnaire comprises seven items that serve to determine how many times a person forgets to take his or her medication. The questionnaire's validity was demonstrated (sensitivity: 71 %; specificity: 72%; correct classification: 72%; odds ratio: 6.15) using immunologic (CD4 count) and virologic (viral load) parameters as validation criteria. Adherence is defined as the intake of at least 95% of prescribed tablets.",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nhave to be under ART for at least six months¸\nhave internet access\n\nExclusion Criteria:\n\nbe pregnant\nactive IV drug user\nactual diagnosis of psychiatric health problem",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"José Côté, Ph.D.",
                "OverallOfficialAffiliation":"CRCHUM, Université de Montréal",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Gaston Godin, Ph.D.",
                "OverallOfficialAffiliation":"Laval University",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Yann-Gael Guéhéneuc, Ph.D.",
                "OverallOfficialAffiliation":"Polytechnique",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Cécile Tremblay, MD,Ph.D.",
                "OverallOfficialAffiliation":"CRCHUM",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Joanne Otis, Ph.D.",
                "OverallOfficialAffiliation":"Université du Québec a Montréal",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"José Côté",
                "LocationCity":"Montréal",
                "LocationState":"Quebec",
                "LocationZip":"H2X 0A9",
                "LocationCountry":"Canada"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"23039306",
                "ReferenceType":"derived",
                "ReferenceCitation":"Côté J, Godin G, Guéhéneuc YG, Rouleau G, Ramirez-Garcìa P, Otis J, Tremblay C, Fadel G. Evaluation of a real-time virtual intervention to empower persons living with HIV to use therapy self-management: study protocol for an online randomized controlled trial. Trials. 2012 Oct 5;13:187. doi: 10.1186/1745-6215-13-187."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Related Info",
                "SeeAlsoLinkURL":"http://www.crsi.umontreal.ca"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M16833",
                "ConditionBrowseLeafName":"HIV Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2103",
                "ConditionBrowseLeafName":"Acquired Immunodeficiency Syndrome",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC02",
                "ConditionBrowseBranchName":"Viral Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC20",
                "ConditionBrowseBranchName":"Immune System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}