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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
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"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
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These subjects will participate in completing various PRO instruments and targeted questions.","arm_type":""}],"assignment":"","brief_summary":"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.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Real-world insights of people with human immunodeficiency virus (HIV) infection","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 17:23:48","criteria":"Inclusion Criteria: - >= 21 years old - Language:Read and Understand English / Spanish - Positive diagnosis of HIV infection by a healthcare provider (self-reported) - Possesses a smartphone that has internet access Exclusion Criteria: - Not Applicable","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"","display_phase_internal":"","display_status":"Ongoing","display_status_internal":"RECSTATUS_O_ONGOING","endpoint":"","enrollment":"3000","exclusion":"","gender":"All","gender_based":"No","gender_description":"","healthy_volunteers":"No","id":"e33b6810-4600-52ed-9ed3-84759e1882a9","internal":{"content":null,"contentDigest":"40332f2c274ba979ead9e4549161526a","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - >= 21 years old - Language:Read and Understand English / Spanish - Positive diagnosis of HIV infection by a healthcare provider (self-reported) - Possesses a smartphone that has internet access Exclusion Criteria: - Not Applicable","interventions":[{"arm_group_label":"Subjects living with HIV","intervention_description":"Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.","intervention_name":"Functional Assessment of HIV Infection","intervention_type":"Other"},{"arm_group_label":"Subjects living with HIV","intervention_description":"Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.","intervention_name":"Patient Satisfaction Questionnaire","intervention_type":"Other"},{"arm_group_label":"Subjects living with HIV","intervention_description":"Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.","intervention_name":"Symptom Distress Module","intervention_type":"Other"},{"arm_group_label":"Subjects living with HIV","intervention_description":"Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.","intervention_name":"Patient Health Questionnaire","intervention_type":"Other"},{"arm_group_label":"Subjects living with HIV","intervention_description":"Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.","intervention_name":"Internalized Stigma of AIDS Tool","intervention_type":"Other"},{"arm_group_label":"Subjects living with HIV","intervention_description":"Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. 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QoL assessment will include physical well-being, social well-being, emotional well-being, functional and global well-being, and cognitive functioning","outcome_measure":"Percentage of virally suppressed PLHIV reporting different HRQoL scores","outcome_time_frame":"Up to 1 Week","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_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","outcome_measure":"Percentage of virally suppressed PLHIV reporting different satisfaction with care scores","outcome_time_frame":"Up to 1 Week","outcome_safety_issue":null},{"outcome_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.","outcome_measure":"Percent difference in HRQoL scores among subject subgroups","outcome_time_frame":"Up to 1 Week","outcome_safety_issue":null},{"outcome_description":"Statistical correlation of reported QoL scores (FAHI) and satisfaction with care scores (PHQ-18) will be analyzed.","outcome_measure":"Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care","outcome_time_frame":"Up to 1 Week","outcome_safety_issue":null},{"outcome_description":"Statistical correlation between QoL scores (FAHI) and adherence scores (adherence VAS) will be analyzed.","outcome_measure":"Percentage of subjects reporting diffferent HRQoL and medication adherence","outcome_time_frame":"Up to 1 Week","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["Evidera","mProve"]},"start_date":"01/18/2018 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"208141"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}