HIV/AIDSNCT03873129
ART-CHESS: A Mobile Health Application to Support People Living With HIV and Addiction
A study testing mobile health app (mHealth) in people with HIV/AIDS and Substance Use Disorders, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Substance Use Disorders
- What is being tested?
- mobile health app (mHealth)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2019to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing HIV Care for Patients With Substance Use Disorders Using Predictive Analytics in a Mobile Health Application
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.
Read the 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
- Being tested
- mobile health app (mHealth)
- Keywords
- antiretroviral therapy, HIV transmission
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile health app (mHealth)Behavioural
Also called ART-CHESS
A-CHESS is a mobile health app for participants to interact with their treatment team for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| A-CHESS | Experimental | participant will be using the A-CHESS mobile app for 12 months Receives: Behavioral: mobile health app (mHealth) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Attendance at HIV clinic appointments
Measured: up to 12 months
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.
Measured: up to 12 months
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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start12 Mar 2019
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ryan Westergaard, MD, PhD, MPH, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873129
- Sponsor's protocol ID
- 2016-1190
- Other IDs
- A534265, SMPH\MEDICINE\INFECT DIS, 1DP2DA042424-01, Protocol Version 3/20/20
- Status last verified
- Jun 2020
- First submitted
- 11 Mar 2019
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing HIV Care for Patients With Substance Use Disorders Using Predictive Analytics in a Mobile Health Application
- ClinicalTrials.gov ID
- NCT03873129
- Acronym / sponsor ID
- 2016-1190
- Conditions
- HIV/AIDS, Substance Use Disorders
- Keywords
- antiretroviral therapy, HIV transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| A-CHESS | Experimental | Behavioral: mobile health app (mHealth)participant will be using the A-CHESS mobile app for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile health app (mHealth)Also: ART-CHESSA-CHESS is a mobile health app for participants to interact with their treatment team for 12 months. | Behavioural | A-CHESS |
Primary outcome
Change in the Viral suppression among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Time frame: Up to 12 months
Viral suppression will be measured each 6 months period. HIV RNA< 200 copies/mL reflects viral suppression per protocol.
3 secondary outcomes
Change in the Attendance at HIV Clinic Appointments among study semesters of A-CHESS use versus semesters of without A-CHESS use.
Time frame: up to 12 months
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Westergaard, MD, PhD, MPH principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile health app (mHealth) in people with HIV/AIDS and Substance Use Disorders, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Viral suppression among study semesters of A-CHESS use versus semesters of without A-CHESS use. (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.