Clinical trial NCT05398185: WiseApp for Spanish Speakers Living with HIV
Official title: WiseApp for Spanish-Speaking Latino Persons Living with HIV (PLWH) in the United States (US) and the Dominican Republic (DR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Acquired Immune Deficiency Syndrome
Sexually Transmitted Diseases, Viral
Keywords: People living with HIV (PLWH)
Antiretroviral therapy (ART)
Mobile Health
Spanish Speakers
Latinos
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Clínica de Familia La Romana, Dominican Republic
First posted: 2022-05-31
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in self-reported ART adherence
timeFrame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
Secondary outcomes:
measure: Change in cluster of differentiation 4 (CD4) Count
timeFrame: Baseline, 3 month follow up, and 6 month follow up
measure: Change in Viral Load
timeFrame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
measure: Change In Participant's Self-reported Health-related Quality of Life Score
timeFrame: Baseline and 12 month follow up
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: La Romana
country: Dominican Republic
facility: Clinica de Familia La Romana
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: