WiseApp for Spanish-Speaking Latino HIV Patients
This study aims to assess if using the WiseApp can help Spanish-speaking Latino HIV patients improve their adherence to antiretroviral therapy.
CleverCap
Blood-Borne Infections+16
+ Urogenital Diseases
+ Genital Diseases
Supportive Care Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.248 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Columbia University Irving Medical Center
New York, United StatesOpen Columbia University Irving Medical Center in Google MapsClinica de Familia La Romana
La Romana, Dominican Republic