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

HIV Infections Clinical Trial

— RISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03400293
• Other study ID #: 208141
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: July 7, 2018

Study information

• Verified date: March 2019
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1184
• Est. completion date: July 7, 2018
• Est. primary completion date: July 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

Intervention

Other:
• Functional Assessment of HIV Infection
Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.
• Patient Satisfaction Questionnaire
Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.
• Symptom Distress Module
Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.
• Patient Health Questionnaire
Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.
• 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.
• 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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Arlington	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
ViiV Healthcare	Evidera, mProve

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of virally suppressed PLHIV reporting different HRQoL scores	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	Percentage of virally suppressed PLHIV reporting different satisfaction with care scores	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
Secondary	Percent difference in HRQoL scores among subject subgroups	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
Secondary	Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care	Statistical correlation of reported QoL scores (FAHI) and satisfaction with care scores (PHQ-18) will be analyzed.	Up to 1 Week
Secondary	Percentage of subjects reporting diffferent HRQoL and medication adherence	Statistical correlation between QoL scores (FAHI) and adherence scores (adherence VAS) will be analyzed.	Up to 1 Week