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WiseApp for HIV

N/A

Recruiting

Led By Rebecca Schnall, PhD, MPH

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having been diagnosed with HIV ≥6 months ago

Aged ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 month follow up, 6 month follow up, and 12 month follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial will adapt a mobile app and a smart pill dispenser for Spanish-speaking people living with HIV in NYC and the Dominican Republic. They will assess the efficacy and sustainability of the app, as well as identify barriers to its widespread use among Spanish speakers.

Who is the study for?

This trial is for Spanish-speaking adults living with HIV in NYC or La Romana, DR. Participants must have been diagnosed at least 6 months ago, have an HIV-1 RNA level >50 copies/mL, own a smartphone, and be willing to join any part of the study. It's not for those in long-term care facilities, planning to move soon, from the same household as another participant, terminally ill or with certain cognitive impairments.

What is being tested?

The WiseApp mobile app and smart pill dispenser are being tested over a year-long randomized controlled trial among Spanish speakers with HIV. The goal is to adapt these technologies for better engagement and clinical outcomes by understanding barriers specific to this group.

What are the potential side effects?

Since WiseApp is a technology-based intervention without direct medical treatments or drugs involved, there may not be traditional side effects; however participants might experience privacy concerns or stress related to using new technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with HIV more than 6 months ago.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 month follow up, 6 month follow up, and 12 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 month follow up, 6 month follow up, and 12 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 month follow up, 6 month follow up, and 12 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in self-reported ART adherence

Secondary study objectives

Change In Participant's Self-reported Health-related Quality of Life Score

Change in Viral Load

Change in cluster of differentiation 4 (CD4) Count

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 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.

Group II: ControlActive Control1 Intervention

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.

0 / 2Eligibility criteria met