WiseApp for Spanish Speakers Living With HIV

NCT ID: NCT05398185

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2027-01-31

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.

Detailed Description

While efforts have been made, deficits remain in antiretroviral therapy (ART) adherence and viral suppression among PLWH. There are gaps in HIV treatment success that are particularly present in racial and ethnic minority populations, especially among Latinos in the Northeast United States (US) and the Caribbean. The progression and premature deaths among PLWH have been attributed to insufficient engagement in medical care and adherence to HIV treatments. Access and adherence to ART are important to therapeutic success and help determine long-term health outcomes in PLWH. The investigators studied racial/ethnic minorities and their providers to identify the impact a mobile app can have to improve health outcomes. The Agency for Healthcare Research and Quality (AHRQ) helped create this app and integrated it with a smart pill box (CleverCap) which allows PLWH to monitor their medication adherence. The tool, WiseApp, is a better method than other ART adherence methods because the app is linked to the smart pill box and is currently being evaluated in random-control trials (RCT) in New York City. There is also a need to develop and test self-management interventions for Spanish speaking Latino PLWH because they are the largest and fastest growing ethnic minority group in the US and are disproportionately affected by HIV. The investigators suggest the transfer of WiseApp to Latinos in the US and the DR by translating it to Spanish and making it culturally accessible. The project will use health information technology to facilitate the collection of medication adherence, quality of life, and symptom burden data.

This study aims to adapt WiseApp for Spanish speaking PLWH and conduct RCT to assess the app's efficacy and sustainability. The study will identify barriers and facilitators to the widespread use of the app and builds on the strong linkage between Columbia University and Clínica de Familia in the DR. This project is also enhanced by utilizing the strong presence of Latinos in the Washington Heights neighborhood of NYC, the disproportionately high rates of HIV in the DR, and patterns of movement of people between NYC and the DR. Additionally, the study focuses on AHRQ priority populations such as chronically ill, inner-city, low-income, and racial/ethnic minority persons.

Conditions

HIV Infections; Acquired Immune Deficiency Syndrome; Sexually Transmitted Diseases, Viral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type: EXPERIMENTAL

CleverCap

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clínica de Familia La Romana, Dominican Republic

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Schnall, RN, MPH, PhD

Mary Dickey Lindsay Professor of Disease Prevention and Health Promotion

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Schnall, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Clinica de Familia La Romana

La Romana, Dominican Republic, Dominican Republic

Site Status: RECRUITING

Countries

United States; Dominican Republic

Central Contacts

Rebecca Schnall, PhD, MPH

Role: CONTACT

rb897@columbia.edu

212-342-6886

Claudia Michaels

Role: CONTACT

clm2241@cumc.columbia.edu

Facility Contacts

Rebecca Schnall, PhD, MPH

Role: primary

rb897@columbia.edu

212-342-6886

Pamela Baez Caraballo, MD, MSc

Role: primary

pamela@clinicadefamilia.org.do

809-813-2934 ext. 130

References

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.

Reference Type: DERIVED

PMID: 38233908 (View on PubMed)

Other Identifiers

1R18HS028523-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

AAAT8632

Identifier Type: -

Identifier Source: org_study_id