WiseApp for Spanish Speakers Living With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
CleverCap
DeviceThe 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.
Treatment groups
248 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in self-reported ART adherence
Self-reported ART adherence is a single-item self-report measure on a linear scale of 0-100 with zero indicating lowest adherence and 100 indicating highest adherence.
Time frame
Baseline, 3 month follow up, 6 month follow up, and 12 month follow upSecondary outcomes
1
Change in cluster of differentiation 4 (CD4) Count
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 up2
Change in Viral Load
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 up3
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.
Time frame
Baseline and 12 month follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Clínica de Familia La Romana, Dominican Republic
Collaborator
Source ClinicalTrials.gov