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Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection (RISE)

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ClinicalTrials.gov Identifier: NCT03400293
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : March 11, 2019
Sponsor:
Collaborators:
Evidera
mProve
Information provided by (Responsible Party):
ViiV Healthcare

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.

Condition or disease Intervention/treatment
HIV Infections 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

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Study Type : Observational
Actual Enrollment : 1184 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: RISE: Real World Insights of People Living With HIV Shared Through Electronic Devices
Actual Study Start Date : January 18, 2018
Actual Primary Completion Date : July 7, 2018
Actual Study Completion Date : July 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Subjects living with HIV
Subjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions.
Other: Functional Assessment of HIV Infection
Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.

Other: Patient Satisfaction Questionnaire
Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.

Other: Symptom Distress Module
Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.

Other: Patient Health Questionnaire
Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.

Other: Internalized Stigma of AIDS Tool
Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.

Other: Medication adherence visual analogue scale
Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.




Primary Outcome Measures :
  1. Percentage of virally suppressed PLHIV reporting different HRQoL scores [ Time Frame: Up to 1 Week ]
    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


Secondary Outcome Measures :
  1. Percentage of virally suppressed PLHIV reporting different satisfaction with care scores [ Time Frame: Up to 1 Week ]
    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

  2. Percent difference in HRQoL scores among subject subgroups [ Time Frame: Up to 1 Week ]
    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.

  3. Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care [ Time Frame: Up to 1 Week ]
    Statistical correlation of reported QoL scores (FAHI) and satisfaction with care scores (PHQ-18) will be analyzed.

  4. Percentage of subjects reporting diffferent HRQoL and medication adherence [ Time Frame: Up to 1 Week ]
    Statistical correlation between QoL scores (FAHI) and adherence scores (adherence VAS) will be analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400293


Locations
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United States, Virginia
GSK Investigational Site
Arlington, Virginia, United States, 22209
Sponsors and Collaborators
ViiV Healthcare
Evidera
mProve
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare

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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT03400293     History of Changes
Other Study ID Numbers: 208141
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ViiV Healthcare:
Human Immunodeficiency virus
Health Related Quality of Life
Functional Assessment of HIV Infection
Mobile app

Additional relevant MeSH terms:
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HIV Infections
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Slow Virus Diseases
Infection
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Immune System Diseases