Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection (RISE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03400293|
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : March 11, 2019
|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|
|Study Type :||Observational|
|Actual Enrollment :||1184 participants|
|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|
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.
- 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
- 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
- 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.
- 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.
- 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.
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
|United States, Virginia|
|GSK Investigational Site|
|Arlington, Virginia, United States, 22209|
|Study Director:||GSK Clinical Trials||ViiV Healthcare|