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Recruiting NCT05398185

NCT05398185 WiseApp for Spanish Speakers Living With HIV

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Clinical Trial Summary
NCT ID NCT05398185
Status Recruiting
Phase
Sponsor Columbia University
Condition HIV Infections
Study Type INTERVENTIONAL
Enrollment 248 participants
Start Date 2023-03-01
Primary Completion 2026-11-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
CleverCap

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 248 participants in total. It began in 2023-03-01 with a primary completion date of 2026-11-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility 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.

Contact & Investigator

Central Contact

Rebecca Schnall, PhD, MPH

✉ rb897@columbia.edu

📞 212-342-6886

Principal Investigator

Rebecca Schnall, PhD, MPH

PRINCIPAL INVESTIGATOR

Columbia University

Frequently Asked Questions

Who can join the NCT05398185 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05398185 currently recruiting?

Yes, NCT05398185 is actively recruiting participants. Contact the research team at rb897@columbia.edu for enrollment information.

Where is the NCT05398185 trial being conducted?

This trial is being conducted at New York, United States, La Romana, Dominican Republic.

Who is sponsoring the NCT05398185 clinical trial?

NCT05398185 is sponsored by Columbia University. The principal investigator is Rebecca Schnall, PhD, MPH at Columbia University. The trial plans to enroll 248 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology