NCT03873129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2021

Completed
Last Updated

May 5, 2021

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

March 11, 2019

Last Update Submit

May 4, 2021

Conditions

HIV/AIDSSubstance Use Disorders

Keywords

antiretroviral therapyHIV transmission

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 12 months

Secondary Outcomes (3)

  • Change in the Attendance at HIV Clinic Appointments among study semesters of A-CHESS use versus semesters of without A-CHESS use.

    up to 12 months

  • Change in the Drug usage among study semesters of A-CHESS use versus semesters of without A-CHESS use.

    up to 12 months

  • Change in the Medication adherence among study semesters of A-CHESS use versus semesters of without A-CHESS use.

    up to 12 months

Study Arms (1)

A-CHESS

EXPERIMENTAL

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

Behavioral: mobile health app (mHealth)

Interventions

mobile health app (mHealth)BEHAVIORAL

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

Also known as: ART-CHESS
A-CHESS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53597, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSubstance-Related Disorders

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Ryan Westergaard, MD, PhD, MPH

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 13, 2019

Study Start

March 12, 2019

Primary Completion

April 12, 2021

Study Completion

April 12, 2021

Last Updated

May 5, 2021

Record last verified: 2020-06

Locations

US(1)