Recruiting

WiseApp for Spanish-Speaking Latino HIV Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to assess if using the WiseApp can help Spanish-speaking Latino HIV patients improve their adherence to antiretroviral therapy.

What is being tested

CleverCap

Device
Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorColumbia University
Study ContactRebecca Schnall, PhD, MPHMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2023

Actual date on which the first participant was enrolled.

This study is focused on improving health outcomes for Spanish-speaking Latino individuals living with HIV in the United States and the Dominican Republic. These populations face unique challenges in adhering to antiretroviral therapy (ART), which is crucial for managing HIV effectively. The study seeks to enhance ART adherence using a mobile application called WiseApp, which is linked to a smart pill box to help users keep track of their medication. This is particularly important because Latinos are the largest and fastest growing ethnic minority group in the US and are disproportionately affected by HIV. By translating and adapting WiseApp for Spanish speakers, the study aims to make it culturally accessible and improve long-term health outcomes. The study involves testing the WiseApp through randomized controlled trials to evaluate how effective and sustainable it is for Spanish-speaking participants. Participants will use the app to monitor their ART adherence, and the study will collect data on medication adherence, quality of life, and symptom burden. Researchers will also explore the barriers and facilitators to the app's widespread use. The study benefits from the collaboration between Columbia University and Clínica de Familia in the Dominican Republic, as well as the presence of a large Latino community in Washington Heights, New York City. Results will be measured by changes in self-reported ART adherence, using a scale from 0 to 100 to gauge adherence levels.

Official TitleWiseApp for Spanish-Speaking Latino Persons Living With HIV (PLWH) in the United States (US) and the Dominican Republic (DR)
NCT05398185
Principal SponsorColumbia University
Study ContactRebecca Schnall, PhD, MPHMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

248 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAcquired Immunodeficiency SyndromeCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsPathologic ProcessesRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesPathological Conditions, Signs and SymptomsVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus InfectionsDisease Attributes

Criteria

Inclusion Criteria: * Able to speak, read, and write in Spanish; * Aged ≥18 years; * Willing to participate in any assigned arm of the intervention; * Have an HIV-1 RNA level \>50 copies/mL; * Own a smartphone (DR participants who are eligible but without access to a smartphone will get one as part of the study at the time of enrollment); and * Ability and willingness to provide informed consent for study participation and consent for access to medical records. Exclusion Criteria: * Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment; * Terminal illness with life expectancy \<6 months; * Planning to move out of the area in the next 12 months; * A cognitive state minimum score measured by the Mini-Mental State Examination (MMSE) to ensure participants are oriented to time and place. * Spouses/partners may not enroll in this study. The study will be limited to only 1 person from the same family/domestic household.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Columbia University Irving Medical Center

New York, United StatesOpen Columbia University Irving Medical Center in Google Maps
Recruiting

Clinica de Familia La Romana

La Romana, Dominican Republic
Recruiting
2 Study Centers