NCT05398185|Active Not RecruitingDMCFDA Device
WiseApp for Spanish Speakers Living With HIV
WiseApp for Spanish-Speaking Latino Persons Living With HIV (PLWH) in the United States (US) and the Dominican Republic (DR)
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Sponsor study identifier
Secondary identifiers
AHRQ
interventional
241
2 countries
2
Study Start
March 1, 2023
Actual (reported)Primary Completion
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2022
Actual (reported)May 31, 2022
Actual (reported)March 1, 2023
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in self-reported ART adherence
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.
Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
Change in cluster of differentiation 4 (CD4) Count
Baseline, 3 month follow up, and 6 month follow up
Change in Viral Load
Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
The control includes standard health services offered at each site (e.g., mental health services, case-management, referral to clinical care) and a brief adherence educational session.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Columbia University Irving Medical Center
New York, New York, 10032, United States
Clinica de Familia La Romana
La Romana, Dominican Republic, Dominican Republic
Olaya F, Brin M, Caraballo PB, Halpern M, Jia H, Ramirez SO, Padilla JJ, Stonbraker S, Schnall R. A randomized controlled trial of the dissemination of an mHealth intervention for improving health outcomes: the WiseApp for Spanish-speakers living with HIV study protocol. BMC Public Health. 2024 Jan 17;24(1):201. doi: 10.1186/s12889-023-17538-y.
Rebecca Schnall, PhD, MPH
Columbia University
241 participants (actual enrollment reported by the registry).
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
Community-Based Model for Delivery of Antiretroviral Therapy in Cambodia
Change In Participant's Self-reported Health-related Quality of Life Score
Baseline and 12 month follow up
Contact the study team to confirm eligibility.
March 1, 2023
Primary Completion
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 6, 2026
Record last verified: 2026-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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