HIV Infections
Conditions
Keywords
Human Immunodeficiency virus, Health Related Quality of Life, Functional Assessment of HIV Infection, Mobile app
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.
Interventions
OTHERFunctional 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 will be used to assess burden and HRQoL in subjects. This will include 18 items.
OTHERSymptom Distress Module
Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.
Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.
OTHERInternalized Stigma of AIDS Tool
Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.
OTHERMedication adherence visual analogue scale
Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.
Sponsors
Evidera
mProve
ViiV Healthcare
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of virally suppressed PLHIV reporting different HRQoL scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of virally suppressed PLHIV reporting different satisfaction with care scores | 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 | 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 | 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 | Up to 1 Week | Statistical correlation between QoL scores (FAHI) and adherence scores (adherence VAS) will be analyzed. |
Countries
United States
Outcome results
None listed