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ART-CHESS: A Mobile Health Application to Support People Living With HIV and Addiction

Primary Purpose

HIV/AIDS, Substance Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mobile health app (mHealth)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS focused on measuring antiretroviral therapy, HIV transmission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18+ years old
  2. Documentation of HIV infection
  3. Able to read and write in English
  4. A history of substance use disorder, defined as one or more of the following:

    1. A positive result on one or more SUD screening tests (see "Screening," below), reflecting substance use during the prior year.
    2. Current participation in a substance abuse treatment program, including medication assisted treatment for SUD, or regular (at least monthly) participation in SUD-oriented support groups.
    3. A lifetime history of problematic drug or alcohol use AND having been incarcerated in the past year, regardless of the date of last substance use.

Exclusion Criteria:

  1. Individuals who are under 18, are not HIV-positive, who have no history of alcohol or drug misuse, or cannot read and write in English
  2. Individuals who are prohibited from using the internet on any device as a condition of criminal justice supervision
  3. Individuals who cannot demonstrate competency in using the A-CHESS interface on a smartphone or web browser after a standard period of training by a research staff member

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A-CHESS

Arm Description

participant will be using the A-CHESS mobile app for 12 months

Outcomes

Primary Outcome Measures

Change in the Viral suppression among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Viral suppression will be measured each 6 months period. HIV RNA< 200 copies/mL reflects viral suppression per protocol.

Secondary Outcome Measures

Change in the Attendance at HIV Clinic Appointments among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Attendance at HIV clinic appointments
Change in the Drug usage among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Change in the Drug usage among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Change in the Medication adherence among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Change in the Medication adherence among study semesters of A-CHESS use versus semesters of without A-CHESS use.

Full Information

First Posted
March 11, 2019
Last Updated
May 4, 2021
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03873129
Brief Title
ART-CHESS: A Mobile Health Application to Support People Living With HIV and Addiction
Official Title
Optimizing HIV Care for Patients With Substance Use Disorders Using Predictive Analytics in a Mobile Health Application
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is now well-accepted that lowering community-level viral load through expansion of antiretroviral therapy (ART) can reduce HIV transmission among people who use drugs. However, achieving durable viral suppression among patients with substance use disorders is a major challenge for providers and health systems. This study aims to adapt and implement an existing mobile health (mHealth) system, A-CHESS (Addiction Comprehensive Health Enhancement Support System) to improve care for HIV patients with substance use disorders.
Detailed Description
Patients with substance use disorders are continuously at risk for relapse and other disruptive life events, which may lead to lapses in antiretroviral treatment and subsequent viral rebound, thereby increasing their level of infectivity. Behaviors that place others at risk for HIV transmission such as sharing drug paraphernalia and unprotected sex may also increase during these periods of social and behavioral instability. Various biomedical, behavioral, and structural interventions have been used to prevent lapses in HIV care or minimize their impact when they occur. A potentially transformative strategy would be the one that makes novel use of ubiquitous technology and the existing clinical workforce to provide highly-effective, tailored support to the patients at greatest risk, at the time and place it is needed the most. This study has 2 phases: Phase I has been completed and it was an observational study, not a clinical trial. Patients who volunteered were recruited to use the mobile phone app to enter data, but it was not intended to improve their health or health care. The data collected during phase 1 will be used to inform the intervention in phase 2, where the study team hope to use the system to improve patient care. Phase 2 will conduct a single-arm implementation study (with historical controls) of A-CHESS when implemented in 2 high-volume HIV clinics, providing evidence describing the effectiveness and durability of an mHealth strategy for maintaining viral suppression among patients with substance use disorders treated with ART. The long-term goal of this project is to develop a comprehensive mHealth system that identifies the critical time-varying determinants of lapses in HIV care for substance using patients, and translates these diverse inputs into actionable, patient-specific alerts to clinical providers. This goal will be achieved by adapting and implementing an existing mHealth intervention, A-CHESS, which might improve HIV care for patients with substance use disorders through two mechanisms. First, existing A-CHESS services will improve treatment adherence by enhancing self-determination (i.e., intrinsic motivation, competence and social relatedness). Second, through new functionality incorporating predictive analytics with patient-level data, A-CHESS will identify moments when patients are at the highest risk for antiretroviral treatment failure, allowing clinic-based staff to provide targeted interventions that maximize the efficiency of care coordination resources. If successful, this project would translate important individual and neighborhood-level data into timely and clinically-relevant knowledge that is accessible to the HIV care team, representing a major step forward in our ability to support patients with complex needs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Substance Use Disorders
Keywords
antiretroviral therapy, HIV transmission

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Phase 2 is single group trial of A-CHESS when implemented in 2 high-volume HIV clinics, providing evidence describing the effectiveness and durability of an mHealth strategy for maintaining viral suppression among patients with substance use disorders treated with ART.
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A-CHESS
Arm Type
Experimental
Arm Description
participant will be using the A-CHESS mobile app for 12 months
Intervention Type
Behavioral
Intervention Name(s)
mobile health app (mHealth)
Other Intervention Name(s)
ART-CHESS
Intervention Description
A-CHESS is a mobile health app for participants to interact with their treatment team for 12 months.
Primary Outcome Measure Information:
Title
Change in the Viral suppression among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Description
Viral suppression will be measured each 6 months period. HIV RNA< 200 copies/mL reflects viral suppression per protocol.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Change in the Attendance at HIV Clinic Appointments among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Description
Attendance at HIV clinic appointments
Time Frame
up to 12 months
Title
Change in the Drug usage among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Description
Change in the Drug usage among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Time Frame
up to 12 months
Title
Change in the Medication adherence among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Description
Change in the Medication adherence among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18+ years old Documentation of HIV infection Able to read and write in English A history of substance use disorder, defined as one or more of the following: A positive result on one or more SUD screening tests (see "Screening," below), reflecting substance use during the prior year. Current participation in a substance abuse treatment program, including medication assisted treatment for SUD, or regular (at least monthly) participation in SUD-oriented support groups. A lifetime history of problematic drug or alcohol use AND having been incarcerated in the past year, regardless of the date of last substance use. Exclusion Criteria: Individuals who are under 18, are not HIV-positive, who have no history of alcohol or drug misuse, or cannot read and write in English Individuals who are prohibited from using the internet on any device as a condition of criminal justice supervision Individuals who cannot demonstrate competency in using the A-CHESS interface on a smartphone or web browser after a standard period of training by a research staff member
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Westergaard, MD, PhD, MPH
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53597
Country
United States

12. IPD Sharing Statement

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ART-CHESS: A Mobile Health Application to Support People Living With HIV and Addiction

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