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mHealth Facilitated Intervention for HIV/AIDS (Super SMART Trial)

N/A

Recruiting

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

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

Must have

diagnosed with HIV

prescribed ART

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.

Awards & highlights

Super SMART Trial Summary

This trial is testing a new way to help people with HIV take their medication regularly, which could improve their health.

Who is the study for?

This trial is for adults over 18 living with HIV who have not been fully adhering to their ART medication and have had a detectable viral load in the past 6 months. It's not suitable for those with physical or cognitive impairments, active psychosis, or non-English speakers.Check my eligibility

What is being tested?

The study tests if a health coaching session combined with a mobile app that reminds patients to take their HIV medication and allows remote access to a health coach can improve adherence compared to just having the health coaching session.See study design

What are the potential side effects?

Since this trial focuses on using technology and personal coaching rather than new medications, there are no direct medical side effects. However, participants may experience stress or anxiety from regular reminders or technical issues with the app.

Super SMART Trial Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with HIV.

Select...

I am currently taking antiretroviral therapy.

Select...

I am 18 years old or older.

Select...

I sometimes miss taking my medication.

Super SMART Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Electronic Pillbox ART Adherence

HIV Viral Load

Secondary outcome measures

ART Adherence Barriers

Depressive Symptoms

HIV Stigma

+2 more

Other outcome measures

HIV Treatment Retention

Intervention Feedback

Medical Mistrust

+5 more

Super SMART Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: mHealth Facilitated Adherence CoachingExperimental Treatment2 Interventions

Group II: ControlActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityOTHER

1,640 Previous Clinical Trials

2,560,296 Total Patients Enrolled

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

66,607 Total Patients Enrolled

Media Library

Carium Mobile Health Platform Clinical Trial Eligibility Overview. Trial Name: NCT05046392 — N/A

HIV/AIDS Research Study Groups: mHealth Facilitated Adherence Coaching, Control

HIV/AIDS Clinical Trial 2023: Carium Mobile Health Platform Highlights & Side Effects. Trial Name: NCT05046392 — N/A

Carium Mobile Health Platform 2023 Treatment Timeline for Medical Study. Trial Name: NCT05046392 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate headcount of participants in this clinical experiment?

"That is accurate. According to clinicaltrials.gov, this medical trial first began recruiting patients on October 6th 2021 and was recently updated on December 13th 2021. Currently 400 participants are being sought from two different sites for the study."

Answered by AI

Is the recruitment phase for this study still open?

"Affirmative, the clinicaltrials.gov page indicates that this medical experiment is presently recruiting patients. This trial was initially made available on October 6th 2021 and has been updated most recently on December 13th 2021. A total of 400 participants will be recruited from two separate locations for the study."

Answered by AI

What are the anticipated outcomes of this experiment?

"This experiment's primary endpoint is the change in HIV Viral Load over a one-year period. Other secondary outcomes include Depressive Symptoms (measured by CESD with scores from 0 - 60), HIV Treatment Adherence Self-Efficacy (using HIV-ASES, 12 items in total), and HIV Stigma (via The HIV Stigma Scale, with values ranging from 40 - 160)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV

2021. "mHealth Facilitated Intervention to Improve Medication Adherence Among Persons Living With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05046392.