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)
2 other identifiers
interventional
248
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
Started Mar 2023
Typical duration for not_applicable hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2022
CompletedFirst Posted
Study publicly available on registry
May 31, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
February 27, 2026
February 1, 2026
3.7 years
May 25, 2022
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
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
Change In Participant's Self-reported Health-related Quality of Life Score
Baseline and 12 month follow up
Study Arms (2)
Control
NO INTERVENTIONThe 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.
Intervention
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Columbia University Irving Medical Center
New York, New York, 10032, United States
Clinica de Familia La Romana
La Romana, Dominican Republic
Related Publications (1)
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.
PMID: 38233908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca Schnall, PhD, MPH
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be randomly assigned to one of two trial arms using sequentially numbered, opaque, sealed envelopes containing the intervention assignment, which the staff member opens at the moment of randomization
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion
Study Record Dates
First Submitted
May 25, 2022
First Posted
May 31, 2022
Study Start
March 1, 2023
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share