- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398185
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)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rebecca Schnall, PhD, MPH
- Phone Number: 212-342-6886
- Email: rb897@columbia.edu
Study Contact Backup
- Name: Felix Olaya, MPH
- Email: fmo2110@cumc.columbia.edu
Study Locations
-
-
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La Romana, Dominican Republic
- Recruiting
- Clinica de Familia La Romana
-
Contact:
- Pamela Baez Caraballo, MD, MSc
- Phone Number: 130 809-813-2934
- Email: pamela@clinicadefamilia.org.do
-
-
-
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New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center
-
Contact:
- Rebecca Schnall, PhD, MPH
- Phone Number: 212-342-6886
- Email: rb897@columbia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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; 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
WiseApp that delivers medication adherence reminders
|
The Intervention group will receive the WiseApp that delivers medication adherence reminders
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in self-reported ART adherence
Time Frame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
|
Self-reported ART adherence will be measured using a 3-item scale with responses transformed to a linear scale of 0-100 with zero indicating lowest adherence and 100 indicating highest adherence.
Summary scales will be calculated as the mean of the three scale items.
|
Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cluster of differentiation 4 (CD4) Count
Time Frame: Baseline, 3 month follow up, and 6 month follow up
|
Using blood samples obtained during study visits, CD4 count will be used to assess ART adherence.
|
Baseline, 3 month follow up, and 6 month follow up
|
Change in Viral Load
Time Frame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
|
Using blood samples obtained during study visits, viral load levels will be used to assess ART adherence.
|
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
Time Frame: Baseline and 12 month follow up
|
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life.
In general, each question has five response options ranging in values from 1-5.
To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed.
Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10.
Consequently, a person with a T-score of 40 would be one SD below the mean.
|
Baseline and 12 month follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca Schnall, PhD, MPH, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Virus Diseases
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Sexually Transmitted Diseases
- Sexually Transmitted Diseases, Viral
Other Study ID Numbers
- AAAT8632
- 1R18HS028523-01 (U.S. AHRQ Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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