WiseApp for HIV

Recruiting at 1 trial location

Overseen By Felix Olaya, MPH

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

Trial Summary

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 data supports the effectiveness of the WiseApp treatment for HIV?

Research shows that mHealth apps like WiseApp can help people with HIV manage their medication better, which is crucial for keeping the virus under control. The WiseApp trial aims to improve medication adherence by using real-time monitoring and linking it to a smart pill dispenser, which has shown promise in other studies for improving adherence in similar settings. ^{1 2 3 4 5}

Is WiseApp safe for humans?

The WiseApp and Wisepill have been tested for usability and feasibility in people living with HIV, showing they are generally safe to use. Some technical issues were noted, but no significant safety concerns were reported in the studies. ^{2 3 4 5 6}

What makes the WiseApp treatment unique for managing HIV?

The WiseApp treatment is unique because it combines a mobile app with a smart pill dispenser to provide real-time monitoring of medication adherence, helping people with HIV manage their health more effectively by ensuring they take their medication on time. ^{2 3 4 7 8}

What is the purpose of this trial?

This study aims to conduct a 12-month randomized controlled trial to adapt the mobile app, WiseApp, and a smart pill dispenser for Spanish-speaking people living with HIV (PLWH) in the New York City (NYC) area and La Romana, Dominican Republic (DR). The study will assess the efficacy and sustainability of WiseApp as well as identify barriers with its widespread use among Spanish speakers. With disproportionately high rates of HIV in the New York City area and the Dominican Republic, this project seeks to identify distinct contextual factors related to Spanish speaking people living with HIV and increase the likelihood of engagement with technology and improvements in clinical outcomes.

Research Team

Rebecca Schnall, PhD, MPH

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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 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]

References

1. United States 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. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

A Multi-step Usability Evaluation of a Self-Management App to Support Medication Adherence in Persons Living with HIV. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Real-time adherence monitoring for HIV antiretroviral therapy. [2022]

5. England 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. [2023]

6. England 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. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional Study. [2021]

8. Spain pubmed.ncbi.nlm.nih.gov

Mobile applications in HIV self-management: A systematic review of scientific literature. [2022]