WiseApp for Spanish Speakers Living With HIV

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05398185
Status
Recruiting

Conditions

  • Acquired Immune Deficiency Syndrome
  • HIV Infections
  • Sexually Transmitted Diseases, Viral

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CleverCap — DEVICE
    The 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.

Study Details

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.

Key Dates

Start date
Mar 1, 2023
Status verified
Feb 2026
Primary completion
Nov 1, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
248 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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
    Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp.

Primary Outcome Measure

Change in self-reported ART adherence [ Time Frame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Rebecca Schnall, PhD, MPH
212-342-6886

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