Face-to-Face ART Adherence Intervention for HIV/AIDS

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Emory University, Atlanta, GAHIV/AIDS+2 MoreFace-to-Face ART Adherence Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • HIV/AIDS
  • Telemedicine
  • Medication Adherence

Treatment Effectiveness

Effectiveness Progress

1 of 3

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TMB-365/TMB-380

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.

12 Months
Electronic Pillbox ART Adherence
HIV Viral Load
12- & 24- month follow-up interviews.
HIV Treatment Retention
Intervention Feedback
12-month follow-up interview.
Time Spent Delivering Intervention
Baseline, 1-, 3-, 6-, & 12-month follow-up interviews.
Depressive Symptoms
HIV Stigma
Medical Mistrust
Medications
Substance Use
Treatment Fatigue
Treatment Received
Baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.
ART Adherence Barriers
HIV Treatment Adherence Self-Efficacy
Self-Reported ART Adherence

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
USE-MI System
1
START mHealth Intervention
1
TMB-365/TMB-380

Trial Design

2 Treatment Groups

Control
1 of 2
mHealth Facilitated Adherence Coaching
1 of 2

Active Control

Experimental Treatment

400 Total Participants · 2 Treatment Groups

Primary Treatment: Face-to-Face ART Adherence Intervention · No Placebo Group · N/A

mHealth Facilitated Adherence CoachingExperimental Group · 2 Interventions: Carium Mobile Health Platform, Face-to-Face ART Adherence Intervention · Intervention Types: Behavioral, Behavioral
Control
Behavioral
ActiveComparator Group · 1 Intervention: Face-to-Face ART Adherence Intervention · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1-, 3-, 6-, 12-, 18-, & 24-month follow-up interviews.

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
241 Previous Clinical Trials
58,805 Total Patients Enrolled
Emory UniversityOTHER
1,523 Previous Clinical Trials
2,713,119 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently taking medication for HIV (ART).
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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