HIV (Human Immunodeficiency Virus)VIP-HANANCT03182738

Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms

A study testing VIP app without HIV-related symptom strategies. and VIP app that delivers HIV-related symptom strategies. in people with HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immunodeficiency Syndrome), run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to use technology to improve symptom status and ultimately improve patient centered outcomes in people living with HIV/AIDS (PLWHA). The primary purpose of the intervention (VIP-HANA) is to improve symptom status. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV (Human Immunodeficiency Virus), AIDS (Acquired Immunodeficiency Syndrome)
What is being tested?: VIP app without HIV-related symptom strategies. and VIP app that delivers HIV-related symptom strategies.
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 16 Nov 2016to 31 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV+
Age 18 or over
Able to read and respond in English
Reside within the US
Willing to participate in an online survey.

Who cannot join

HIV-negative
under age 18
Unwilling to provide key data (i.e., age, information about symptoms) on the online survey.

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University School for Nursing
New York, New York, 10032

Other trials in United States

About this study

Read the detailed description

As PLWHA age, they are developing chronic illnesses and co-morbid conditions that are often seen in older HIV negative patients. HANA conditions (e.g., cardiovascular disease, liver disease, diabetes, and asthma) are becoming more common as PLWHA age.

An individual's ability to identify and self-manage symptoms of HIV illness has been shown to improve patient outcomes and quality of life. The investigators will develop and pilot test the Video Information Provider (VIP), a web application (app) that delivered HIV-related symptom self-care strategies for PLWHA for 13 common (non-HANA) HIV/AIDS symptoms. There is a need to identify the symptom experience of PLWHA with HANA conditions.

The aim is to compare the efficacy of VIP-HANA to a control arm for ameliorating symptom frequency and intensity and secondary health outcomes in 100 PLWHA with HANA conditions over 6 months.

Conditions: HIV (Human Immunodeficiency Virus), AIDS (Acquired Immunodeficiency Syndrome)
Being tested: VIP app without HIV-related symptom strategies., VIP app that delivers HIV-related symptom strategies.
Keywords: HIV/AIDS Health Management App, HIV/AIDS symptoms
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VIP app without HIV-related symptom strategies.Behavioural
The control group will receive the VIP app without HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.Behavioural
The Intervention group will receive the VIP app that delivers HIV-related symptom strategies

Study groups in NCT03182738
Study group	Role	What they receive
Intervention	Experimental	VIP app that delivers HIV-related symptom strategies Receives: Behavioral: VIP app that delivers HIV-related symptom strategies.
Control	Sham comparator	VIP app without HIV-related symptom strategies Receives: Behavioral: VIP app without HIV-related symptom strategies.

What is being measured

The primary outcome is the main question the study is designed to answer.

Symptom Burden Score
The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome).
Measured: Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months)

Secondary outcomes (1)

Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms.
Measured: Baseline, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Nov 201631 May 2019

First posted9 Jun 2017
Study start16 Nov 2016
Primary completion3 Apr 2019
Study completion31 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV (Human Immunodeficiency Virus)Studies of the same condition, open and under way.
More trials run by Columbia UniversityThe 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: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03182738
Sponsor's protocol ID: AAAP5958
Other IDs: R01NR015737-01A1
Acronym: VIP-HANA
Status last verified: Nov 2019
First submitted: 11 May 2017
Last updated: 13 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gordian-Arroyo A, Reame N, Gutierrez J, Liu J, Ganzhorn S, Igwe KC, Laing K, Schnall R. Do correlates of white matter features differ between older men and women living with human immunodeficiency virus? Menopause. 2023 Feb 1;30(2):149-155. doi: 10.1097/GME.0000000000002102. Epub 2022 Nov 20.
PubMed 36696639
Cho H, Porras T, Flynn G, Schnall R. Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study. J Med Internet Res. 2020 Jun 15;22(6):e17708. doi: 10.2196/17708.
PubMed 32538796

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV (Human Immunodeficiency Virus) trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
ClinicalTrials.gov ID: NCT03182738
Acronym / sponsor ID: VIP-HANA / AAAP5958
Conditions: HIV (Human Immunodeficiency Virus), AIDS (Acquired Immunodeficiency Syndrome)
Keywords: HIV/AIDS Health Management App, HIV/AIDS symptoms
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 16 Nov 2016 (actual)
Primary completion: 3 Apr 2019 (actual)
Study completion: 31 May 2019 (actual)
First posted: 9 Jun 2017 (actual)
Results: Posted 13 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The aim is to compare the efficacy of VIP-HANA to a control arm for ameliorating symptom frequency and intensity and secondary health outcomes in 100 PLWHA with HANA conditions over 6 months.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: VIP app that delivers HIV-related symptom strategies.VIP app that delivers HIV-related symptom strategies
Control	Sham comparator	Behavioral: VIP app without HIV-related symptom strategies.VIP app without HIV-related symptom strategies

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

HIV+
Age 18 or over
Able to read and respond in English
Reside within the US
Willing to participate in an online survey.

Key exclusion criteria (3 listed)

HIV-negative
under age 18
Unwilling to provide key data (i.e., age, information about symptoms) on the online survey.

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
VIP app without HIV-related symptom strategies.The control group will receive the VIP app without HIV-related symptom strategies	Behavioural	Control
VIP app that delivers HIV-related symptom strategies.The Intervention group will receive the VIP app that delivers HIV-related symptom strategies	Behavioural	Intervention

Primary outcome

Symptom Burden Score
Time frame: Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months)
The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome).

1 secondary outcome

Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29
Time frame: Baseline, 3 months, and 6 months

Results and safety

Results posted to the registry on 13 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	50	41
Control	50	45

Primary outcome: Symptom Burden Score

Time frame: Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months). Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention n = 50	Control n = 50
Anxiety - period 1	1.08 (1.47)	1.06 (1.49)
Anxiety - period 2	0.83 (1.36)	0.71 (1.37)
Anxiety - period 3	0.80 (1.34)	0.78 (1.38)
Changes in appetite - period 1	0.85 (1.36)	0.70 (1.19)
Changes in appetite - period 2	0.79 (1.34)	0.67 (1.21)
Changes in appetite - period 3	0.76 (1.36)	0.55 (1.15)
Clumsiness or difficulty with balance - period 1	0.88 (1.49)	0.82 (1.39)
Clumsiness or difficulty with balance - period 2	0.83 (1.41)	0.66 (1.28)

Intervention vs Control: Difference in Change: -0.32, p = 0.02, Linear mixed model
Intervention vs Control: Difference in Change: -0.29, p = 0.11, Linear mixed model
Intervention vs Control: Difference in Change: -0.29, p = 0.02, Linear mixed model

Population analysed: The statistical analysis defined the time points into 3 periods to correlate with the baseline, 3-month, and 6-month visits. Not all participants completed the symptom burden scale and therefore did not align within the 3 designated periods.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected over a 1 year time period.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Control	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36696639Gordian-Arroyo A, Reame N, Gutierrez J, Liu J, Ganzhorn S, Igwe KC, Laing K, Schnall R. Do correlates of white matter features differ between older men and women living with human immunodeficiency virus? Menopause. 2023 Feb 1;30(2):149-155. doi: 10.1097/GME.0000000000002102. Epub 2022 Nov 20.
Derived from this study: PubMed 32538796Cho H, Porras T, Flynn G, Schnall R. Usability of a Consumer Health Informatics Tool Following Completion of a Clinical Trial: Focus Group Study. J Med Internet Res. 2020 Jun 15;22(6):e17708. doi: 10.2196/17708.
Individual participant dataSharing planned: No

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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.

Rebecca Schnall, PhD principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 3 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 13 Dec 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 13 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Symptom Burden Score (time frame: Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03182738, which also lists 2 linked publications.

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 13 Dec 2019.