WiseApp for HIV

Recruiting at 1 trial location

Overseen By Claudia Michaels

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Nursing home, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

248 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called WiseApp, designed to help Spanish-speaking individuals living with HIV manage their condition more effectively. The study will evaluate the app's effectiveness over a year and identify factors that influence user adherence. Participants will either use the app with a smart pill dispenser that tracks medication use or receive standard health services. Ideal candidates are Spanish speakers with HIV in the New York City area or the Dominican Republic, who own a smartphone and are open to trying new tech tools for health management. As an unphased trial, this study allows participants to contribute to innovative research that could enhance HIV management tools for Spanish speakers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that WiseApp and the smart pill dispenser are safe for Spanish-speaking people living with HIV?

Research has shown that WiseApp, when used with a smart pill dispenser, helps people with HIV manage their medications. Previous studies found that users appreciated the app and it helped them take their medications on time. No major problems or side effects have been reported from using WiseApp, indicating that it is safe and effective for people with HIV. The app aims to simplify and enhance medication management, greatly assisting in handling the condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WiseApp because it integrates innovative technology with medication adherence for HIV treatment. Unlike traditional methods that rely solely on patient memory or manual tracking, WiseApp uses the CleverCap pill bottle, which dispenses the exact prescribed amount of medication and wirelessly communicates with the app. This approach not only ensures consistent medication intake but also provides real-time tracking and feedback. By enhancing adherence in a user-friendly way, WiseApp has the potential to improve treatment outcomes significantly.

What evidence suggests that WiseApp is effective for people living with HIV?

Research has shown that the WiseApp, a mobile health app, can help people with HIV manage their medication more effectively. Early studies indicate it assists users in adhering to their antiretroviral therapy (ART) as prescribed, which is crucial for controlling HIV. However, while the app initially improves medication habits, sustaining this improvement over time has proven challenging. In this trial, participants in the intervention arm will use the WiseApp alongside a smart pill dispenser, which ensures the correct amount of medication is taken and tracks usage. This technology aims to simplify treatment management, potentially leading to better health outcomes. ^{1 2 4 6 7}

Who Is on the Research Team?

Rebecca Schnall, PhD, MPH

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for Spanish-speaking adults living with HIV in NYC or La Romana, DR. Participants must have been diagnosed at least 6 months ago, have an HIV-1 RNA level >50 copies/mL, own a smartphone, and be willing to join any part of the study. It's not for those in long-term care facilities, planning to move soon, from the same household as another participant, terminally ill or with certain cognitive impairments.

Inclusion Criteria

Have an HIV-1 RNA level >50 copies/mL

Ability and willingness to provide informed consent for study participation and consent for access to medical records

I can speak, read, and write in Spanish.

Exclusion Criteria

Planning to move out of the area in the next 12 months

Terminal illness with life expectancy <6 months

Spouses/partners may not enroll in this study. The study will be limited to only 1 person from the same family/domestic household.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the WiseApp and CleverCap pill bottle to monitor and improve ART adherence

12 months

Baseline, 3 month, 6 month, and 12 month follow-ups

Follow-up

Participants are monitored for changes in ART adherence, CD4 count, viral load, and health-related quality of life

12 months

Baseline, 3 month, 6 month, and 12 month follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• WiseApp

Trial Overview The WiseApp mobile app and smart pill dispenser are being tested over a year-long randomized controlled trial among Spanish speakers with HIV. The goal is to adapt these technologies for better engagement and clinical outcomes by understanding barriers specific to this group.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp.

Group II: Control Active Control 1 Intervention

The control includes standard health services offered at each site (e.g., mental health services, case-management, referral to clinical care) and a brief adherence educational session.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Clínica de Familia La Romana, Dominican Republic

Collaborator

Trials

1

Recruited

250+

Published Research Related to This Trial

The WiseApp trial is testing a mobile health technology designed to improve adherence to antiretroviral therapy (ART) among underserved individuals living with HIV in New York City, with 200 participants followed for 6 months.

The app features real-time medication monitoring and personalized support, which may help patients manage their treatment better and prevent drug resistance, making it a promising tool for enhancing HIV self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp). Flynn, G., Jia, H., Reynolds, NR., et al.[2021]

The WiseApp, a mobile health application designed for people living with HIV, underwent a thorough usability evaluation involving end-users and experts, leading to important design improvements for better user experience.

The iterative feedback process from think-aloud protocols and cognitive walkthroughs confirmed that the app and its linked devices are user-friendly, enhancing the potential for effective self-management of health in individuals with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multi-step Usability Evaluation of a Self-Management App to Support Medication Adherence in Persons Living with HIV. Beauchemin, M., Gradilla, M., Baik, D., et al.[2020]

The PrEP-EmERGE mobile health app was found to be highly usable and acceptable among users, with a median usability score of 78 out of 100, indicating that users generally found the app easy to use.

A significant 90% of users would recommend the app to a friend, and 96% rated their satisfaction as excellent, good, or satisfactory, highlighting its effectiveness in supporting HIV pre-exposure prophylaxis (PrEP) management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of PrEP EmERGE - A novel digital health innovation designed to support sexual health clinics and HIV-PrEP users. Fitzpatrick, C., Richardson, D., Sherriff, N., et al.[2023]

The Wisepill wireless monitoring system demonstrated a median adherence level of 93% over 6 months in a pilot study with 10 Ugandan individuals, showing its potential for real-time tracking of antiretroviral therapy adherence.

This real-time monitoring could help identify suboptimal adherence before viral rebound occurs, which is crucial for preventing treatment failure in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time adherence monitoring for HIV antiretroviral therapy. Haberer, JE., Kahane, J., Kigozi, I., et al.[2022]

The study aims to evaluate the effectiveness of the Wisepill digital adherence technology (DAT) in improving antiretroviral treatment adherence among children and adolescents living with HIV in Tanzania, involving a formative study and randomized clinical trials.

Participants in the intervention group will use the Wisepill dispenser along with daily reminder texts and tailored feedback, with the goal of enhancing adherence and retention in care, potentially leading to a scalable solution for HIV treatment in the National Aids Control Programmes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a customized digital adherence tool on retention in care and adherence to antiretroviral treatment in breastfeeding women, children and adolescents living with HIV in Tanzania: a mixed-methods study followed by clinical trials. Sumari-de Boer, IM., Ngowi, KM., Swai, IU., et al.[2023]

A 16-week pilot study involving 15 HIV-infected individuals demonstrated that a co-encapsulated pill sensor system effectively monitored pill ingestion in real-time, with 80% of participants completing follow-up through 8 weeks.

The majority of participants found the system comfortable and helpful, with 75% reporting the patch was comfortable and only 10-15% not finding the text message reminders useful, indicating good acceptability of the monitoring system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time and Wireless Assessment of Adherence to Antiretroviral Therapy With Co-Encapsulated Ingestion Sensor in HIV-Infected Patients: A Pilot Study. Daar, ES., Rosen, MI., Wang, Y., et al.[2021]

The iReach randomized controlled trial successfully identified and prevented 624 cases of potential fraudulent or ineligible enrollment among same-sex attracted, cisgender males aged 13-18, using a combination of electronic and manual authentication strategies.

79% of these cases were detected through electronic methods, highlighting the effectiveness of technology in maintaining data integrity and reducing the need for extensive manual reviews in web-based trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional Study. Guest, JL., Adam, E., Lucas, IL., et al.[2021]

A systematic review identified 17 mobile health (mHealth) apps aimed primarily at people living with HIV (PLHIV), focusing on self-management, medication adherence, and treatment support, indicating a strong emphasis on improving health outcomes for this population.

The study found that these apps, mostly available for Android and often free, have shown a positive impact on antiretroviral therapy adherence and overall self-care, highlighting the potential of mHealth strategies in managing HIV effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications in HIV self-management: A systematic review of scientific literature. Mehraeen, E., SeyedAlinaghi, S., Pashaei, Z., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03205982

The Wise App Trial for Improving Health Outcomes in PLWH 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 ...

2. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/wise-app-trial-improving-health-outcomes-plwh

The Wise App Trial for Improving Health Outcomes in PLWH The use of a mobile health application can improve chronic disease self-management and medication adherence for people with HIV.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9933073/

Efficacy of an mHealth self-management intervention for ... The WiseApp intervention initially improved ART adherence but did not have a sustained effect on outcomes.

4. pattern.health pattern.health/portfolio/wiseapp/

WiseApp - Pattern Health The overall goal of the WiseApp study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its ...

5. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/dissemination-wiseapp-improving-health-outcomes-across-settings

Dissemination of the WiseApp for Improving Health Outcomes ... This research will evaluate the use of WiseApp, a medication tracker mobile app linked to a smart pill box aimed at improving medication adherence in those ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33238931/

the WiseApp trial for improving health outcomes in PLWH ... The WiseApp contains real-time medication monitoring linking an electronic pill bottle and fitness tracker to the app, helping persons living with HIV (PLWH) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686828/

the WiseApp trial for improving health outcomes in PLWH ... The WiseApp Trial has the potential to improve HIV self-management applications, being one of the few randomized controlled trials of a mHealth ...