HIV InfectionsRISENCT03400293
Real-world Insights of People With Human Immunodeficiency Virus (HIV) Infection
An observational study of HIV Infections, run by ViiV Healthcare at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Functional Assessment of HIV Infection, Patient Satisfaction Questionnaire and Symptom Distress Module
- How many people
- 1,184 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2018to 7 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- >= 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
Who cannot join
- Not Applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RISE: Real World Insights of People Living With HIV Shared Through Electronic Devices
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.
- Conditions
- HIV Infections
- Being tested
- Functional Assessment of HIV Infection, Patient Satisfaction Questionnaire, Symptom Distress Module, Patient Health Questionnaire, Internalized Stigma of AIDS Tool
- Keywords
- Human Immunodeficiency virus, Health Related Quality of Life, Functional Assessment of HIV Infection, Mobile app
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Assessment of HIV InfectionOther
Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.
Patient Satisfaction QuestionnaireOther
Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.
Symptom Distress ModuleOther
Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.
Patient Health QuestionnaireOther
Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.
Internalized Stigma of AIDS ToolOther
Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.
Medication adherence visual analogue scaleOther
Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 1 Week
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start18 Jan 2018
- Primary completion7 Jul 2018
- Study completion7 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Evidera, mProve
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400293
- Sponsor's protocol ID
- 208141
- Acronym
- RISE
- Status last verified
- Mar 2019
- First submitted
- 10 Jan 2018
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISE: Real World Insights of People Living With HIV Shared Through Electronic Devices
- ClinicalTrials.gov ID
- NCT03400293
- Acronym / sponsor ID
- RISE / 208141
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency virus, Health Related Quality of Life, Functional Assessment of HIV Infection, Mobile app
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,184 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Evidera, mProve
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 7 Jul 2018 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects living with HIV | – | 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 scaleSubjects living with HIV will be recruited via digital advertising. These subjects will participate in completing various PRO instruments and targeted questions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- >= 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
Key exclusion criteria (1 listed)
- Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Assessment of HIV InfectionFunctional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items. | Other | Subjects living with HIV |
| Patient Satisfaction QuestionnairePatient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items. | Other | Subjects living with HIV |
| Symptom Distress ModuleSymptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items. | Other | Subjects living with HIV |
| Patient Health QuestionnairePatient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items. | Other | Subjects living with HIV |
| Internalized Stigma of AIDS ToolInternalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items. | Other | Subjects living with HIV |
| Medication adherence visual analogue scaleMedication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item. | Other | Subjects living with HIV |
Primary outcome
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
4 secondary outcomes
Percentage of virally suppressed PLHIV reporting different satisfaction with care scores
Time frame: Up to 1 Week
Percent difference in HRQoL scores among subject subgroups
Time frame: Up to 1 Week
Percentage of subjects reporting different HRQoL scores and relationship with satisfaction with care
Time frame: Up to 1 Week
Percentage of subjects reporting diffferent HRQoL and medication adherence
Time frame: Up to 1 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
ViiV Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by ViiV Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of virally suppressed PLHIV reporting different HRQoL scores (time frame: Up to 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2019.