The Wise App Trial for Improving Health Outcomes in PLWH

NCT03205982 | Completed Results DMC

• 2 other identifiers: AAAQ9957R01HS025071
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to design a user-centered design app linked to a smart pill box for people living with HIV (PLWH) and evaluate its effects in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a strong theoretical framework building on earlier user-centered design work and integrating a real-time monitoring device, this work has the potential to improve ART adherence in PLWH and have a sustainable public health impact.

Conditions

HIV/AIDS

Keywords

Wisepill; ART; PLWH

Outcome Measures

Primary Outcomes (1)

• Change in ART Adherence - Clever Cap

  The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. We will collect adherence data each day from the start to the end of trial (day 1 to 6 months), and it is a count response (number of times taking medication each day).

  Up to 6 months

Secondary Outcomes (6)

• Change in Score on the Center for Adherence Support Evaluation (CASE) Index

  Baseline, 3 month follow up, and 6 month follow up

• Change in Cluster of Differentiation 4 (CD4) Count

  Baseline, 3 month follow up, and 6 month follow up

• Change in Viral Load

  Baseline, 3 month follow up, and 6 month follow up

• Change in Number of Primary Care Visits

  Baseline, 3 months, and 6 months

• Change in Score on the Engagement With Health Care Provider Scale

  Baseline, 3 months, and 6 months

Study Arms (2)

Control

SHAM COMPARATOR

WiseApp that delivers fitness reminders

Behavioral: Wise app with fitness reminders

Intervention

EXPERIMENTAL

WiseApp that delivers medication adherence reminders

Behavioral: Wise app with medication adherence reminders

Interventions

Wise app with medication adherence reminders BEHAVIORAL

The Intervention group will receive the Wise app that delivers medication adherence reminders.

Intervention

Wise app with fitness reminders BEHAVIORAL

The control group will receive the Wise app with fitness reminders

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of HIV
• Report past 30 days adherence of 80% or less as measured using the Visual Analogue Scale (VAS), or have a viral load of over 400 copies/mL
• Be able to communicate and read in English or Spanish
• Live in the US
• Have a smartphone
• Be taking ART medications

You may not qualify if:

• Participation in any other mobile app study for PLWH, including text messaging studies
• Diagnosis of a clinical problem that would preclude someone from using a smartphone

Sponsors & Collaborators

• Columbia University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (4)

• Alvarez G, Sanabria G, Jia H, Cho H, Reynolds NR, Gradilla M, Olender S, Mohr DC, Schnall R. Do Walk Step Reminders Improve Physical Activity in Persons Living With HIV in New York City?-Results From a Randomized Clinical Trial. J Assoc Nurses AIDS Care. 2023 Nov-Dec 01;34(6):527-537. doi: 10.1097/JNC.0000000000000427. Epub 2023 Sep 25.

  PMID: 37747318 DERIVED

• Sanabria G, Bushover B, Ashrafnia S, Cordoba E, Schnall R. Understanding Physical Activity Determinants in an HIV Self-Management Intervention: Qualitative Analysis Guided by the Theory of Planned Behavior. JMIR Form Res. 2023 Sep 14;7:e47666. doi: 10.2196/47666.

  PMID: 37707942 DERIVED

• Flynn G, Jia H, Reynolds NR, Mohr DC, Schnall R. Protocol of the randomized control trial: the WiseApp trial for improving health outcomes in PLWH (WiseApp). BMC Public Health. 2020 Nov 25;20(1):1775. doi: 10.1186/s12889-020-09688-0.

  PMID: 33238931 DERIVED

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

  PMID: 32779730 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Rebecca Schnall, PhD, MPH
• Organization: Columbia University

rb897@columbia.edu

212-342-6886

Study Officials

• Rebecca Schnall, PhD, RN

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: July 2, 2017
• Study Start: January 31, 2018
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)