mHealth App for HIV with Substance Use Disorder

Recruiting at 7 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

806 Participants Needed

Trial Summary

What is the purpose of this trial?

The current protocol aims to enroll up to 806 participants from 8 study sites in a clinic-supported intervention which will connect them to Vivent Health care team and a cohort of peer mentors for a year-long intervention period to support patient HIV care to maintain viral suppression and clinic appointments.

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 data supports the effectiveness of the mHealth App for HIV with Substance Use Disorder treatment?

Research suggests that mobile health apps can help people with HIV who also have substance use issues by improving medication adherence and offering support for reducing substance use. Digital interventions, like those delivered through apps, can expand access to care and help manage cravings, which may lead to reduced substance use. ^{1 2 3 4 5}

Is the mHealth app for HIV with substance use disorder safe for humans?

The studies suggest that smartphone apps for people with HIV and substance use issues are generally safe and well-received. Participants reported high satisfaction and interest in using these apps, with no significant safety concerns mentioned. ^{4 5 6 7 8}

What makes the mHealth App for HIV with Substance Use Disorder treatment unique?

The mHealth App for HIV with Substance Use Disorder, known as the Connections App, is unique because it uses digital counselors to deliver interventions, which can expand access to care and provide anonymity, making it easier for people with HIV and substance use disorders to engage with treatment and improve their health outcomes. ^{4 5 9 10 11}

Research Team

Ryan Westergaard

Principal Investigator

UW School of Medicine and Public Health

Andrew Quanbeck

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Inventory and Analysis of Controlled Trials of Mobile Phone Applications Targeting Substance Use Disorders: A Systematic Review. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Assessing mobile health feasibility and acceptability among HIV-infected cocaine users and their healthcare providers: guidance for implementing an intervention. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Using Interactive Web-Based Screening, Brief Intervention and Referral to Treatment in an Urban, Safety-Net HIV Clinic. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Pilot feasibility study of Heart2HAART: a smartphone application to assist with adherence among substance users living with HIV. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

A Digital Counselor-Delivered Intervention for Substance Use Among People With HIV: Development and Usability Study. [2023]

6. United States 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. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy of WhatsApp through a harm reduction intervention group for injecting drug users. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Toward understanding the impact of mHealth features for people with HIV: a latent class analysis of PositiveLinks usage. [2022]

9. Canada 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. [2020]

10. Canada 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. [2022]

11. Spain pubmed.ncbi.nlm.nih.gov

Mobile applications in HIV self-management: A systematic review of scientific literature. [2022]