Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT03400293
Status:
COMPLETED
Last Update Posted:
2019-03-11
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073222', 'term': 'Patient Health Questionnaire'}], 'ancestors': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1184}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-08', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of virally suppressed PLHIV reporting different HRQoL scores', 'timeFrame': 'Up to 1 Week', 'description': 'Evaluation of HRQoL will be conducted using scores achieved by Functional Assessment of HIV Infection (FAHI). QoL assessment will include physical well-being, social well-being, emotional well-being, functional and global well-being, and cognitive functioning'}], 'secondaryOutcomes': [{'measure': 'Percentage of virally suppressed PLHIV reporting different satisfaction with care scores', 'timeFrame': 'Up to 1 Week', 'description': 'Evaluation of burden will include stigma, stigma, depression, and work productivity. The descriptive analysis will be assessed using Patient Satisfaction Questionnaire (PSQ)-18, Patient Health Questionnaire (PHQ)-2, and ISAT scores'}, {'measure': 'Percent difference in HRQoL scores among subject subgroups', 'timeFrame': 'Up to 1 Week', 'description': 'Subject subgroups are defined in terms of the following socio-demographic, clinical, and biomedical factors: a. Age: older versus. younger (i.e., \\< 50 years old and over 50 years old) b. Gender (men / women / transgender) c. Race / ethnicity d. Sexual orientation (straight / gay / bisexual) e. Level of income f. Type of Insurance g. Apple (iPhone operating system) versus Android users h. Treatment regimen (e.g., number of pills per day, frequency of medication, single treatment regimen (STR) versus multiple treatment regimen (MTR) i. Diagnosis time / stage at which diagnosis was received (i.e. prompt vs. late diagnosis, time since diagnosis) j. Absence or presence (and number) of comorbidities k. Severity of symptoms (as assessed by the Symptom Distress Module patient reported outcome (PRO) instrument) l. Achievement of viral suppression.'}, {'measure': 'Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care', 'timeFrame': 'Up to 1 Week', 'description': 'Statistical correlation of reported QoL scores (FAHI) and satisfaction with care scores (PHQ-18) will be analyzed.'}, {'measure': 'Percentage of subjects reporting diffferent HRQoL and medication adherence', 'timeFrame': 'Up to 1 Week', 'description': 'Statistical correlation between QoL scores (FAHI) and adherence scores (adherence VAS) will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Immunodeficiency virus', 'Health Related Quality of Life', 'Functional Assessment of HIV Infection', 'Mobile app'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': "This study is designed to identify the burden associated with HIV and its treatment, and assess their health-related quality of life (HRQoL) by measuring key HRQoL domains, including satisfaction with treatment and care, and internalised stigma (ISAT). The study will also explore data for various important subpopulations such as subjects who are virally suppressed; who we anticipate will be the majority of study subjects. The study design is an observational, cross sectional study employing subjects' own mobile phone devices for data entry."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PLHIV will be recruited advertising in digital media. The study plan is to collect a complete set of data from 3000 PLHIV during a 90-180 day period in the US.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 21 years old\n* Language:Read and Understand English / Spanish\n* Positive diagnosis of HIV infection by a healthcare provider (self-reported)\n* Possesses a smartphone that has internet access\n\nExclusion Criteria:\n\n* Not Applicable'}, 'identificationModule': {'nctId': 'NCT03400293', 'acronym': 'RISE', 'briefTitle': 'Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'RISE: Real World Insights of People Living With HIV Shared Through Electronic Devices', 'orgStudyIdInfo': {'id': '208141'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects living with HIV', 'description': 'Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.', 'interventionNames': ['Other: Functional Assessment of HIV Infection', 'Other: Patient Satisfaction Questionnaire', 'Other: Symptom Distress Module', 'Other: Patient Health Questionnaire', 'Other: Internalized Stigma of AIDS Tool', 'Other: Medication adherence visual analogue scale']}], 'interventions': [{'name': 'Functional Assessment of HIV Infection', 'type': 'OTHER', 'description': 'Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.', 'armGroupLabels': ['Subjects living with HIV']}, {'name': 'Patient Satisfaction Questionnaire', 'type': 'OTHER', 'description': 'Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.', 'armGroupLabels': ['Subjects living with HIV']}, {'name': 'Symptom Distress Module', 'type': 'OTHER', 'description': 'Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.', 'armGroupLabels': ['Subjects living with HIV']}, {'name': 'Patient Health Questionnaire', 'type': 'OTHER', 'description': 'Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.', 'armGroupLabels': ['Subjects living with HIV']}, {'name': 'Internalized Stigma of AIDS Tool', 'type': 'OTHER', 'description': 'Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.', 'armGroupLabels': ['Subjects living with HIV']}, {'name': 'Medication adherence visual analogue scale', 'type': 'OTHER', 'description': 'Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.', 'armGroupLabels': ['Subjects living with HIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22209', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Evidera', 'class': 'INDUSTRY'}, {'name': 'mProve', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}