CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
Group A_No feedback +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04418076
NCT04418076N/ACompleted
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Improving Antiretroviral Adherence and Persistence Using mHealth Tools in HIV-infected Cocaine Users

Yale University·interventional·Posted Jun 5, 2020·Updated May 15, 2023

In Brief

A clinical study evaluating Group A_No feedback, Group B_Automated feedback, and 2 other interventions for HIV/AIDS and Cocaine Use. Completed, enrolled 78 participants across 1 site.

Detailed Summary

The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART) adherence and persistence among HIV-infected individuals with co-occurring cocaine use disorders (CUDs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS, Cocaine Use
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), University at Albany, University of Connecticut, National Institute on Drug Abuse (NIDA)

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 5, 2020
Enrollment StartJun 8, 2017
Primary CompletionAug 18, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.1 years ago

Interventions

Group A_No feedbackdevice

In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.

Group B_Automated feedbackdevice

For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.

Group C_Automated feedback + Clinician feedbackdevice

For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.

Group D_Automated feedback + Social Network feedbackdevice

For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.