WiseApp for Spanish Speakers Living With HIV

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05398185

Collaborator

Clínica de Familia La Romana, Dominican Republic (Other)

248

Enrollment

Locations

Arms

Anticipated Duration (Months)

124

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Acquired Immune Deficiency Syndrome Sexually Transmitted Diseases, Viral	Behavioral: WiseApp	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

248 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Primary Purpose:

Supportive Care

Official Title:

WiseApp for Spanish-Speaking Latino Persons Living With HIV (PLWH) in the United States (US) and the Dominican Republic (DR)

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.
Experimental: Intervention WiseApp that delivers medication adherence reminders	Behavioral: WiseApp The Intervention group will receive the WiseApp that delivers medication adherence reminders

Arm

Intervention/Treatment

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.

Experimental: Intervention

WiseApp that delivers medication adherence reminders

Behavioral: WiseApp

The Intervention group will receive the WiseApp that delivers medication adherence reminders

Outcome Measures

Primary Outcome Measures

Change in self-reported ART adherence [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.

Secondary Outcome Measures

Change in cluster of differentiation 4 (CD4) Count [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.
Change in Viral Load [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.
Change In Participant's Self-reported Health-related Quality of Life Score [Baseline, 3 month follow up, 6 month follow up, 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.
Change in Symptom Burden Score [Baseline, 3 month follow up, 6 month follow up, and 12 month follow up]
The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome).
Change in Engagement with Health Care Provider Score [Baseline, 3 month follow up, 6 month follow up, and 12 month follow up]
The Engagement with Health Care Provider 13-item Scale will be administered over the course of the trial to evaluate how participants' engagement with their health care providers changes their health care access overall. Items are scored such that higher scores indicate a more negative relationship with their health care provider, where the maximum total score is 52.
Change in HIV Stigma Mechanism Measure Score [Baseline, 3 month follow up, 6 month follow up, and 12 month follow up]
HIV Stigma Mechanism Measure will be administered over the course of the trial to evaluate how participants' internalized, anticipated and enacted HIV-related stigma changes overall. Items will be measured with 6 items and rated on 5-point Likert-type scales with higher scores indicating greater stigma.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)(158) 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.