HIV/AIDSWiseAppNCT03205982
The Wise App Trial for Improving Health Outcomes in PLWH
A study testing Wise app with medication adherence reminders and Wise app with fitness reminders in people with HIV/AIDS, run by Columbia University at 1 site in United States.
Trial summary
The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Wise app with medication adherence reminders and Wise app with fitness reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2018to 24 Nov 2021
- 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
- Have a diagnosis of HIV
- Report past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL
- Be able to communicate and read in English or Spanish
- Live in the US
- Have a smartphone
- Be taking ART medications
Who cannot join
- Participation in any other mobile app study for PLWH, including text messaging studies
- Diagnosis of a clinical problem that would preclude someone from using a smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: The Wise App Trial for Improving Health Outcomes in People Living With HIV
The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.
Read the detailed description
Human Immunodeficiency virus (HIV) continues to affect 1.2 million Americans. Achieving viral suppression through adherence to antiretroviral (ART) therapy is a critical determinant of successful transmission prevention and long-term outcomes in HIV-infected patients. However only about 25% of persons living with HIV (PLWH) in the US are virally suppressed, demonstrating the need for effective interventions that enhance ART adherence. mHealth is a tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the need for improving medication adherence in PLWH, and the great promise of mHealth, the investigators propose to build and test a user-centered smartphone app linked to a smart pill box targeting ART adherence in PLWH. Self-report of medication adherence is often criticized since it typically overestimated adherence especially in unmasked trials. Current adherence assessments, such as patient recall, pill counts and pharmacy refill data, typically detect missed doses long after they occur. This study will use real-time, wireless monitoring strategies via the Wisepill dispenser, for measuring ART adherence.
- Conditions
- HIV/AIDS
- Being tested
- Wise app with medication adherence reminders, Wise app with fitness reminders
- Keywords
- Wisepill, ART, PLWH
- 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.
Wise app with medication adherence remindersBehavioural
The Intervention group will receive the Wise app that delivers medication adherence reminders.
Wise app with fitness remindersBehavioural
The control group will receive the Wise app with fitness reminders
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | WiseApp that delivers fitness reminders Receives: Behavioral: Wise app with fitness reminders |
| Intervention | Experimental | WiseApp that delivers medication adherence reminders Receives: Behavioral: Wise app with medication adherence reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ART Adherence - Clever Cap
The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day).
Measured: Up to 6 months
Secondary outcomes (6)
Change in Score on the Center for Adherence Support Evaluation (CASE) Index
The CASE Adherence Index is an easy to administer instrument that provides an alternative method for assessing ART adherence in clinical settings. Items are scored such that higher values indicate better adherence, minimum score is 3 and the maximum total score is 16. Scores of 11 or higher on this index indicate good adherence (Cronbach's α= 0.79).
Measured: Baseline, 3 month follow up, and 6 month follow up
Change in Cluster of Differentiation 4 (CD4) Count
Using blood samples obtained during study visits, CD4 count will be used to asses ART adherence
Measured: Baseline, 3 month follow up, and 6 month follow up
Change in Viral Load
Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence.
Measured: Baseline, 3 month follow up, and 6 month follow up
Change in Number of Primary Care Visits
This will be measured by the self-reported number of primary care visits.
Measured: Baseline, 3 months, and 6 months
Change in Score on the Engagement With Health Care Provider Scale
The Engagement with Health Care Provider 13-item Scale will be administered over the course of the trial to evaluate how participants' engagement with their health care providers changes their health care access overall. Items are scored such that higher scores indicate a more negative relationship with their health care provider. The minimum total score is 13 and the maximum total score is 52.
Measured: Baseline, 3 months, and 6 months
Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire
Technology Acceptance: Perceived Ease of Use and Potential Usefulness 14-item Questionnaire provides a method for assessing participants' perception of the usefulness of the technology. Items are scored such that higher values indicate more positive perception. The minimum total score is 0 and the maximum total score is 70.
Measured: Baseline, 3 month follow up and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start31 Jan 2018
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
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 (4)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Rebecca Schnall, PhD, RN, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205982
- Sponsor's protocol ID
- AAAQ9957
- Other IDs
- R01HS025071
- Acronym
- WiseApp
- Status last verified
- Mar 2024
- First submitted
- 24 May 2017
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez G, Sanabria G, Jia H, Cho H, Reynolds NR, Gradilla M, Olender S, Mohr DC, Schnall R. Do Walk Step Reminders Improve Physical Activity in Persons Living With HIV in New York City?-Results From a Randomized Clinical Trial. J Assoc Nurses AIDS Care. 2023 Nov-Dec 01;34(6):527-537. doi: 10.1097/JNC.0000000000000427. Epub 2023 Sep 25.
PubMed 37747318Sanabria G, Bushover B, Ashrafnia S, Cordoba E, Schnall R. Understanding Physical Activity Determinants in an HIV Self-Management Intervention: Qualitative Analysis Guided by the Theory of Planned Behavior. JMIR Form Res. 2023 Sep 14;7:e47666. doi: 10.2196/47666.
PubMed 37707942Flynn G, Jia H, Reynolds NR, Mohr DC, Schnall R. Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp). BMC Public Health. 2020 Nov 25;20(1):1775. doi: 10.1186/s12889-020-09688-0.
PubMed 33238931Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
PubMed 32779730
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Wise App Trial for Improving Health Outcomes in People Living With HIV
- ClinicalTrials.gov ID
- NCT03205982
- Acronym / sponsor ID
- WiseApp / AAAQ9957
- Conditions
- HIV/AIDS
- Keywords
- Wisepill, ART, PLWH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.
Detailed description
Human Immunodeficiency virus (HIV) continues to affect 1.2 million Americans. Achieving viral suppression through adherence to antiretroviral (ART) therapy is a critical determinant of successful transmission prevention and long-term outcomes in HIV-infected patients. However only about 25% of persons living with HIV (PLWH) in the US are virally suppressed, demonstrating the need for effective interventions that enhance ART adherence. mHealth is a tool that has proven useful in supporting behavior change, but most mHealth tools for PLWH have not been well-developed or evaluated. Given the dearth of useful and likeable apps, the need for improving medication adherence in PLWH, and the great promise of mHealth, the investigators propose to build and test a user-centered smartphone app linked to a smart pill box targeting ART adherence in PLWH. Self-report of medication adherence is often criticized since it typically overestimated adherence especially in unmasked trials. Current adherence assessments, such as patient recall, pill counts and pharmacy refill data, typically detect missed doses long after they occur. This study will use real-time, wireless monitoring strategies via the Wisepill dispenser, for measuring ART adherence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Behavioral: Wise app with fitness remindersWiseApp that delivers fitness reminders |
| Intervention | Experimental | Behavioral: Wise app with medication adherence remindersWiseApp that delivers medication adherence reminders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a diagnosis of HIV
- Report past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL
- Be able to communicate and read in English or Spanish
- Live in the US
- Have a smartphone
Key exclusion criteria (2 listed)
- Participation in any other mobile app study for PLWH, including text messaging studies
- Diagnosis of a clinical problem that would preclude someone from using a smartphone
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 |
|---|---|---|
| Wise app with medication adherence remindersThe Intervention group will receive the Wise app that delivers medication adherence reminders. | Behavioural | Intervention |
| Wise app with fitness remindersThe control group will receive the Wise app with fitness reminders | Behavioural | Control |
Primary outcome
Change in ART Adherence - Clever Cap
Time frame: Up to 6 months
The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day).
6 secondary outcomes
Change in Score on the Center for Adherence Support Evaluation (CASE) Index
Time frame: Baseline, 3 month follow up, and 6 month follow up
Change in Cluster of Differentiation 4 (CD4) Count
Time frame: Baseline, 3 month follow up, and 6 month follow up
Change in Viral Load
Time frame: Baseline, 3 month follow up, and 6 month follow up
Change in Number of Primary Care Visits
Time frame: Baseline, 3 months, and 6 months
Change in Score on the Engagement With Health Care Provider Scale
Time frame: Baseline, 3 months, and 6 months
Change in Score on the Perceived Ease of Use and Potential Usefulness Questionnaire
Time frame: Baseline, 3 month follow up and 6 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37747318Alvarez G, Sanabria G, Jia H, Cho H, Reynolds NR, Gradilla M, Olender S, Mohr DC, Schnall R. Do Walk Step Reminders Improve Physical Activity in Persons Living With HIV in New York City?-Results From a Randomized Clinical Trial. J Assoc Nurses AIDS Care. 2023 Nov-Dec 01;34(6):527-537. doi: 10.1097/JNC.0000000000000427. Epub 2023 Sep 25.
- Derived from this study: PubMed 37707942Sanabria G, Bushover B, Ashrafnia S, Cordoba E, Schnall R. Understanding Physical Activity Determinants in an HIV Self-Management Intervention: Qualitative Analysis Guided by the Theory of Planned Behavior. JMIR Form Res. 2023 Sep 14;7:e47666. doi: 10.2196/47666.
- Derived from this study: PubMed 33238931Flynn G, Jia H, Reynolds NR, Mohr DC, Schnall R. Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp). BMC Public Health. 2020 Nov 25;20(1):1775. doi: 10.1186/s12889-020-09688-0.
- Derived from this study: PubMed 32779730Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
- 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, RN 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?
A study testing Wise app with medication adherence reminders and Wise app with fitness reminders in people with HIV/AIDS, run by Columbia University 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 6 inclusion and 2 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 12 Mar 2024. 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 12 Mar 2024). 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?
Change in ART Adherence - Clever Cap (time frame: Up to 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 NCT03205982, which also lists 4 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 12 Mar 2024.