WiseApp for Spanish Speakers Living With HIV
Primary Purpose
HIV Infections, Acquired Immune Deficiency Syndrome, Sexually Transmitted Diseases, Viral
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
WiseApp
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Infections focused on measuring People living with HIV (PLWH), Antiretroviral therapy (ART), Mobile Health, Spanish Speakers, Latinos
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;
- Having been diagnosed with HIV ≥6 months ago;
- 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.
Sites / Locations
- Columbia University Irving Medical CenterRecruiting
- Clinica de Familia La RomanaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
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.
WiseApp that delivers medication adherence reminders
Outcomes
Primary Outcome Measures
Change in self-reported ART adherence
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.
Secondary Outcome Measures
Change in cluster of differentiation 4 (CD4) Count
Using blood samples obtained during study visits, CD4 count will be used to assess ART adherence.
Change in Viral Load
Using blood samples obtained during study visits, viral load levels will be used to assess ART adherence.
Change In Participant's Self-reported Health-related Quality of Life Score
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.
Full Information
NCT ID
NCT05398185
First Posted
May 25, 2022
Last Updated
February 15, 2023
Sponsor
Columbia University
Collaborators
Clínica de Familia La Romana, Dominican Republic
1. Study Identification
Unique Protocol Identification Number
NCT05398185
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Clínica de Familia La Romana, Dominican Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Acquired Immune Deficiency Syndrome, Sexually Transmitted Diseases, Viral
Keywords
People living with HIV (PLWH), Antiretroviral therapy (ART), Mobile Health, Spanish Speakers, Latinos
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
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
Allocation
Randomized
Enrollment
248 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
WiseApp that delivers medication adherence reminders
Intervention Type
Behavioral
Intervention Name(s)
WiseApp
Intervention Description
The Intervention group will receive the WiseApp that delivers medication adherence reminders
Primary Outcome Measure Information:
Title
Change in self-reported ART adherence
Description
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.
Time Frame
Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
Secondary Outcome Measure Information:
Title
Change in cluster of differentiation 4 (CD4) Count
Description
Using blood samples obtained during study visits, CD4 count will be used to assess ART adherence.
Time Frame
Baseline, 3 month follow up, and 6 month follow up
Title
Change in Viral Load
Description
Using blood samples obtained during study visits, viral load levels will be used to assess ART adherence.
Time Frame
Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
Title
Change In Participant's Self-reported Health-related Quality of Life Score
Description
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.
Time Frame
Baseline and 12 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Having been diagnosed with HIV ≥6 months ago;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Schnall, PhD, MPH
Phone
212-342-6886
Email
rb897@columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Janeth Juarez Padilla
Email
jj3211@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Schnall, PhD, MPH
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Schnall, PhD, MPH
Phone
212-342-6886
Email
rb897@columbia.edu
Facility Name
Clinica de Familia La Romana
City
La Romana
Country
Dominican Republic
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Baez Caraballo, MD, MSc
Phone
809-813-2934
Ext
130
Email
pamela@clinicadefamilia.org.do
12. IPD Sharing Statement
Plan to Share IPD
No
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WiseApp for Spanish Speakers Living With HIV
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