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Behavioral Intervention

Electronic Monitoring Device for HIV (A-TEAM Trial)

Phase 3

Recruiting

Led By Mark Dworkin, MD

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

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

Must have

* be \>18 years of age;

* AAMSM \>18 years with self-reported HIV infection;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of month 1, month 2, month 3, month 4, month 5 and at 6 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to test a device that reminds people to take their medication at the right time. If the device detects that the medication was not taken for 2 or 7 consecutive days, it will

Who is the study for?

This trial is for African American men who have sex with men, over 18 years old, living with HIV and struggling with medication adherence. They must be on antiretroviral therapy (ART) for at least six months, own a cell phone, and have either a detectable viral load or self-reported poor adherence. A supportive case manager or person from their social circle also needs to participate.

What is being tested?

The 'A-Team' intervention uses an electronic pill container that alerts the user when it's time to take their medication and notifies a support person if doses are missed. The study will test its effectiveness in improving ART adherence and achieving viral suppression over six months in a randomized controlled trial.

What are the potential side effects?

Since this trial focuses on monitoring drug intake rather than testing new drugs, there aren't direct side effects from medications being studied. However, participants may experience privacy concerns or stress related to the real-time monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I am over 18 years old and have self-reported as HIV positive.

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I have been on antiretroviral therapy for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of month 1, month 2, month 3, month 4, month 5 and at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of month 1, month 2, month 3, month 4, month 5 and at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of month 1, month 2, month 3, month 4, month 5 and at 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Viral load suppression

Secondary study objectives

Adherence

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: A-TEAMExperimental Treatment1 Intervention

This arm receives the A-TEAM approach where the men, their social support (if they have one), and their case manager participate. If the adherence device identifies non-opening of the device, the men are alerted by text or email the same day. If the device identifies non-opening of the device two days in a row, the social support (or case manager) is notified, and if 7 days of non-opening is detected, the case manager is notified.

Group II: ControlActive Control1 Intervention

The men are monitored with the adherence device but there is no intervention on their adherence - they otherwise experience routine care and they don't receive alerts if they the device detects non-openings.

0 / 3Eligibility criteria met