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Behavioural Intervention

mHealth App for HIV with Substance Use Disorder

N/A

Waitlist Available

Led By Ryan Westergaard

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Individuals who do not currently have a smartphone or are unwilling to obtain a smartphone will not be able to participate in this study.

People appearing to lack capacity to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will connect 806 HIV patients to healthcare and peer mentors for 1 year to help them stay healthy and keep clinic appointments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves using an app rather than medication, traditional side effects are not expected. However, users may experience stress or anxiety related to technology use or reminders about their health condition.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incremental Cost per Quality-Adjusted Life-Year Gained through Increased Antiretroviral Adherence

Occurrence of Virologic Failure

Percentage of Vivent Health HIV patients who have downloaded and used Connections

Secondary study objectives

Change in "meaningful use" after a private message

Days of "meaningful use" per week

Number of "meaningful use" weeks

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4: mHealth ImplementationExperimental Treatment1 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 ImplementationExperimental Treatment1 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 ImplementationExperimental Treatment1 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 ImplementationExperimental Treatment1 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.

0 / 2Eligibility criteria met