An observational study in HIV Infections, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by ViiV Healthcare · Observational
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.
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.
Exclusion Criteria:
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 · Other: Patient Satisfaction Questionnaire · Other: Symptom Distress Module · Other: Patient Health Questionnaire · Other: Internalized Stigma of AIDS Tool · Other: Medication adherence visual analogue scale
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.
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.
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 will be used to assess burden and HRQoL in subjects. This will include 1 item.
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
Time frame: Up to 1 Week
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 Week
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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ViiV Healthcare