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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects living with HIV<br>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<br>* Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.<br>Other: Patient Satisfaction Questionnaire<br>* Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.<br>Other: Symptom Distress Module<br>* Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.<br>Other: Patient Health Questionnaire<br>* Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.<br>Other: Internalized Stigma of AIDS Tool<br>* Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.<br>Other: Medication adherence visual analogue scale<br>* Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunodeficiency virus, Health Related Quality of Life, Functional Assessment of HIV Infection, Mobile app