NCT05398185 · Columbia University
WiseApp for Spanish Speakers Living With HIV
What this study is about
This study aims to conduct a 12-month randomly assigned 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).
View original scientific description
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.
Interventions
DEVICE
CleverCap
The CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.
Primary outcome measures
Change in self-reported ART adherence
Time frame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
Self-reported ART adherence is a single-item self-report measure on a linear scale of 0-100 with zero indicating lowest adherence and 100 indicating highest adherence.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Collaborators
Clínica de Familia La Romana, Dominican Republic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations