Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

While efforts have been made, deficits remain in antiretroviral therapy (ART) adherence and viral suppression among PLWH. There are gaps in HIV treatment success that are particularly present in racial and ethnic minority populations, especially among Latinos in the Northeast United States (US) and the Caribbean. The progression and premature deaths among PLWH have been attributed to insufficient engagement in medical care and adherence to HIV treatments. Access and adherence to ART are important to therapeutic success and help determine long-term health outcomes in PLWH. The investigators studied racial/ethnic minorities and their providers to identify the impact a mobile app can have to improve health outcomes. The Agency for Healthcare Research and Quality (AHRQ) helped create this app and integrated it with a smart pill box (CleverCap) which allows PLWH to monitor their medication adherence. The tool, WiseApp, is a better method than other ART adherence methods because the app is linked to the smart pill box and is currently being evaluated in random-control trials (RCT) in New York City. There is also a need to develop and test self-management interventions for Spanish speaking Latino PLWH because they are the largest and fastest growing ethnic minority group in the US and are disproportionately affected by HIV. The investigators suggest the transfer of WiseApp to Latinos in the US and the DR by translating it to Spanish and making it culturally accessible. The project will use health information technology to facilitate the collection of medication adherence, quality of life, and symptom burden data. This study aims to adapt WiseApp for Spanish speaking PLWH and conduct RCT to assess the app's efficacy and sustainability. The study will identify barriers and facilitators to the widespread use of the app and builds on the strong linkage between Columbia University and Clínica de Familia in the DR. This project is also enhanced by utilizing the strong presence of Latinos in the Washington Heights neighborhood of NYC, the disproportionately high rates of HIV in the DR, and patterns of movement of people between NYC and the DR. Additionally, the study focuses on AHRQ priority populations such as chronically ill, inner-city, low-income, and racial/ethnic minority persons. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05398185
Study type Interventional
Source Columbia University
Contact Rebecca Schnall, PhD, MPH
Phone 212-342-6886
Email rb897@columbia.edu
Status Recruiting
Phase N/A
Start date March 1, 2023
Completion date January 2027

See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2