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

March 8, 2019 updated by: ViiV Healthcare

RISE: Real World Insights of People Living With HIV Shared Through Electronic Devices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Arlington, Virginia, United States, 22209
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 Week
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.
Up to 1 Week
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.
Up to 1 Week
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.
Up to 1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

Evidera
mProve

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2018

Primary Completion (Actual)

July 7, 2018

Study Completion (Actual)

July 7, 2018

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 10, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208141

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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