mHealth App for HIV with Substance Use Disorder

Enrolling by invitation at 8 trial locations

Overseen By Meridith Mueller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: No smartphone, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with HIV who also face substance use challenges in maintaining their health. It will employ a mobile app called the Connections App to link participants with a healthcare team and peer mentors for support over a year. The trial will evaluate how effectively this app helps users adhere to their HIV care, attend clinic visits, and maintain viral suppression (keeping the virus at low levels). It is suitable for those receiving HIV care at Vivent Health, who have missed medical appointments or medication doses, or who encounter difficulties due to alcohol or drug use. Participants must have a smartphone to join the trial. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for managing HIV and substance use challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Connections App is safe for use in managing HIV with substance use disorder?

Research has shown that the Connections app is an effective tool for individuals with substance use disorder (SUD). It provides 24/7 peer support and leverages technology to help users adhere to their treatment plans and enhance their recovery. The app is user-friendly and includes features such as discussion forums and crisis support.

Although specific studies on the safety of the Connections app do not exist, as it is not a drug or medical procedure, evidence supports its role in helping individuals remain in treatment and recover. The app emphasizes support rather than physical treatment. Therefore, while specific safety data for the app is unavailable, it is generally considered safe, primarily offering guidance and peer support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Connections App because it offers a novel digital approach to managing HIV among individuals with substance use disorder. Unlike traditional treatments that primarily focus on medication adherence and counseling, the Connections App provides an interactive platform that includes weekly check-ins, research surveys, and access to peer mentors. This innovative use of mobile health technology aims to enhance engagement and support behavioral change over the course of a year, potentially leading to better health outcomes and adherence to treatment plans. By integrating digital tools into care, the app seeks to address the unique challenges faced by this population, offering personalized support that's accessible anytime, anywhere.

What evidence suggests that the Connections App is effective for supporting HIV care in patients with substance use disorder?

Research has shown that the Connections App, which participants in this trial will use, helps people with substance use disorder (SUD). One study found that app users were 70% more likely to complete their treatment program compared to non-users. On average, those using the app stayed in treatment 37 days longer than those receiving only standard care. Additionally, over 12,000 app users reported an 88% increase in their confidence to recover. The app provides 24/7 peer support and moderated discussion forums, crucial features that help individuals adhere to their treatment plans. ^{1 2 4 5 6}

Who Is on the Research Team?

Ryan Westergaard

Principal Investigator

UW School of Medicine and Public Health

Andrew Quanbeck

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for people living with HIV who have struggled to keep their virus levels low or attend clinic appointments due to substance use. Participants must be able to read and write in English, have missed HIV care appointments, or have a history of substance use disorders. They need a smartphone and the ability to consent.

Inclusion Criteria

Your HIV RNA levels have exceeded 200 copies/ml in the past year.

Individuals aged 18 years or older, with HIV RNA levels below 200 copies/ml in the past months, no missed visits and negative responses to screening questions about unhealthy alcohol or substance use who have a history of substance abuse disorder or treatment services listed on their patient problem list are eligible.

You satisfy at least one of the following criteria:

Exclusion Criteria

I have a smartphone or am willing to get one for this study.

I am able to understand and make decisions about my health care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Participants engage with the Connections app and peer mentors, complete weekly check-ins, and participate in research surveys over a year-long intervention period

12 months

Weekly check-ins, 4 research surveys

Follow-up

Participants are monitored for effectiveness measures such as viral load and missed clinic visits in the 6-month post-intervention period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Connections App

Trial Overview The trial tests the 'Connections App', which connects patients with an HIV care team and peer mentors for one year. The goal is to help participants maintain viral suppression and improve attendance at clinic appointments through this mobile health intervention.

How Is the Trial Designed?

Group I: Group 4: mHealth Implementation Experimental Treatment 1 Intervention

Next 2 sites begin enrollment 6 months after Group 3. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.

Group II: Group 3: mHealth Implementation Experimental Treatment 1 Intervention

Next 2 sites begin enrollment 6 months after Group 2. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.

Group III: Group 2: mHealth Implementation Experimental Treatment 1 Intervention

Next 2 sites begin enrollment 6 months after Group 1. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.

Group IV: Group 1: mHealth Implementation Experimental Treatment 1 Intervention

First 2 sites begin enrollment. Research participants will be asked to complete weekly-check-in, 4 research surveys and engage in content available in the Connections app and with peer mentors over the course of a year.

Connections App is already approved in United States for the following indications:

Approved in United States as Connections App for:

• Alcohol-associated liver disease (ALD)
• Substance use disorder (SUD)
• Mental health support

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The A-CHESS mobile health application was adapted to include an HCV intervention, providing educational resources and tailored support to improve HCV screening and treatment among individuals with opioid use disorder, with 416 participants enrolled in the study.

Preliminary data showed that among those who had ever tested HCV antibody-positive, a significant proportion were linked to medical care and treated, indicating that integrating HCV services into addiction treatment programs may enhance health outcomes for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. Hochstatter, KR., Gustafson, DH., Landucci, G., et al.[2020]

The Heart2HAART smartphone application was found to be feasible and user-friendly for participants, with 63.2% reporting no difficulty using it and 94.7% stating that medication reminders did not disrupt their daily activities.

Despite the positive feedback on usability, the study found no significant difference in adherence to HIV medication between those using Heart2HAART and the control group, suggesting that further refinements may be needed for the intervention to enhance medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot feasibility study of Heart2HAART: a smartphone application to assist with adherence among substance users living with HIV. Himelhoch, S., Kreyenbuhl, J., Palmer-Bacon, J., et al.[2022]

A study involving 83 patients living with HIV showed that different usage patterns of the PositiveLinks app correlated with viral suppression outcomes, with users categorized into four distinct classes based on their engagement levels.

Maximizers, who frequently used all app features, maintained high viral suppression rates over 12 months, while the As-Needed Communicators, who used the app minimally, experienced a decline in viral suppression, highlighting the importance of consistent app engagement for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward understanding the impact of mHealth features for people with HIV: a latent class analysis of PositiveLinks usage. Canan, CE., Flickinger, TE., Waselewski, M., et al.[2022]

The qualitative study involving 20 users of the SURE Recovery app revealed that first impressions, such as trust and personal recommendations, significantly influence the app's uptake among individuals seeking support for substance use issues.

User engagement with the app improved when it provided positive feelings and relevant content, highlighting the importance of incorporating end-user feedback into app design to enhance its effectiveness in addiction recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons for Uptake and Engagement of a Smartphone App (SURE Recovery) for People in Recovery From Alcohol and Other Drug Problems: Interview Study of App Users. Neale, J., Bowen, AM.[2022]

A systematic review identified 17 mobile health (mHealth) apps aimed primarily at people living with HIV (PLHIV), focusing on self-management, medication adherence, and treatment support, indicating a strong emphasis on improving health outcomes for this population.

The study found that these apps, mostly available for Android and often free, have shown a positive impact on antiretroviral therapy adherence and overall self-care, highlighting the potential of mHealth strategies in managing HIV effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications in HIV self-management: A systematic review of scientific literature. Mehraeen, E., SeyedAlinaghi, S., Pashaei, Z., et al.[2022]

A systematic review of 22 controlled trials found that mobile health applications targeting substance use disorders can effectively reduce substance use, with eight applications showing significant reductions in usage among participants.

Most applications focused on educating users about the risks of substance use and managing cravings, suggesting that addressing cravings is crucial for preventing relapse, although the studies were limited by short durations and variability in their designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inventory and Analysis of Controlled Trials of Mobile Phone Applications Targeting Substance Use Disorders: A Systematic Review. Bahadoor, R., Alexandre, JM., Fournet, L., et al.[2021]

A study involving 26 people living with HIV showed that using a smartphone app to report on antiretroviral therapy (ART) adherence and substance use was highly feasible, with participants completing 95.3% of daily reports over 14 days.

Participants expressed high satisfaction with the app and a willingness to use smartphones for future health behavior reporting, indicating that mobile technology could be a valuable tool for monitoring ART adherence and substance use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Smartphone App for Daily Reports of Substance Use and Antiretroviral Therapy Adherence among HIV-Infected Adults. Przybyla, SM., Eliseo-Arras, RK., Krawiec, G., et al.[2022]

Citations

1. chess.health chess.health/erecovery/connections-app/

Connections | Addiction Recovery Mobile App Proven Results That Justify Investment · 70% Increase in Program Completion Rate · 37 Days Longer in SUD Treatment vs. Standard Care Alone · 71% Decrease in ...

2. healthaffairsinstitute.org healthaffairsinstitute.org/featured-work/chess-health-connections-companion-apps-support-individuals-with-substance-use-disorder-and-their-loved-ones/

CHESS Health Connections, Companion Apps support ... The Companion App is designed to support family, friends, and caregivers of individuals struggling with SUD by providing a smartphone app with a digital ...

3. chess.health chess.health/evidence/

Evidence In a statewide contract across 12,000+ individuals, there was an 88% increase in recovery confidence by those using the Connections app. Source: Digital Tools ...

4. humanservices.arkansas.gov humanservices.arkansas.gov/news/dhs-partners-launch-chess-health-digital-tools-to-support-people-with-substance-use-disorder-sud-and-their-families/

DHS Partners with CHESS Health to Launch Digital Tools to ... The Connections app directly supports individuals impacted by SUD, offering 24/7 peer support, moderated discussion forums, crisis response, ...

5. yes.nm.gov yes.nm.gov/nmhr/s/chess-healths-connections-app?language=en_US

CHESS Health's Connections App The Connections app is an evidence-based smartphone app that helps individuals adhere to their treatment plan and stay in recovery.

6. chess.health chess.health/

CHESS Health: Home Evidence-based digital health solutions for Substance Use Disorder Management - from prevention and intervention to treatment and recovery.