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

NCT ID: NCT03873129

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2021-04-12

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.

Conditions

HIV/AIDS; Substance Use Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A-CHESS

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

Group Type: EXPERIMENTAL

mobile health app (mHealth)

Intervention Type: BEHAVIORAL

A-CHESS is a mobile health app for participants to interact with their treatment team for 12 months.

Interventions

mobile health app (mHealth)

A-CHESS is a mobile health app for participants to interact with their treatment team for 12 months.

Intervention Type: BEHAVIORAL

Other Intervention Names

ART-CHESS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Westergaard, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

A534265

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\INFECT DIS

Identifier Type: OTHER

Identifier Source: secondary_id

1DP2DA042424-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Protocol Version 3/20/20

Identifier Type: OTHER

Identifier Source: secondary_id

2016-1190

Identifier Type: -

Identifier Source: org_study_id