Project SMART Automated Pillbox Study

Not Applicable

Completed

• Conditions: Cocaine Use; HIV/AIDS
• Interventions: Device: Group A_No feedback; Device: Group C_Automated feedback + Clinician feedback; Device: Group D_Automated feedback + Social Network feedback; Device: Group B_Automated feedback

• Registration Number: NCT04418076
• Lead Sponsor: Yale University

Brief 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).

Detailed Description

To conduct qualitative assessments using focus groups of people living with HIV (PLH) who use cocaine and healthcare providers that will assess the acceptability, feasibility, facilitators and barriers of implementing mHealth interventions; and will aid in developing the final design and content of both automated and clinician feedback in preparation for designing a pilot feasibility study.

To conduct a 12-week pilot feasibility RCT among PLH with co-occurring CUDs that will examine the impact of mHealth tools (cellular-enabled smart pill boxes and cell phones) and feedback (no feedback vs. automated feedback vs. automated + clinician feedback) on primary (ART adherence and persistence) and secondary outcomes (HIV viral suppression, cocaine use, retention in HIV care).

Study Timeline

• Study Start: 2017-06-08
• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-05
• Primary Completion: 2020-08-18
• Study Completion: 2020-08-18
• Results First Submitted: 2021-05-13
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Results First Posted: 2023-05-15
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Age equal to or greater than 18 years
• Clinic-confirmed HIV diagnosis
• Currently prescribed or eligible for ART
• Currently has insurance
• Self-reported cocaine use in the past 30 days
• Willing and able to use a cell phone and electronic pill box for the 12-week intervention

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Exclusion Criteria

• Unable to provide informed consent
• Verbally or physically threatening to research staff
• Unable to communicate in either English or Spanish

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No feedback	Group A_No feedback	For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Automated feedback + Clinician feedback	Group C_Automated feedback + Clinician feedback	For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Automated feedback + Social Network feedback	Group D_Automated feedback + Social Network feedback	For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Automated feedback	Group B_Automated feedback	For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.

Primary Outcome Measures

Name	Time	Method
Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period	Week 12	Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.
Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)	Week 16	This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.

Secondary Outcome Measures

Name	Time	Method
Percent Change in CD4 Count From Baseline to Week 12	Baseline and End of intervention (Week 12)	CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline.
Changes in HIV 1 RNA, QN PCR (Copies/ML)	End of intervention (Week 12)	HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.
Retention in Care	up to End of the study (week 16)	Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months).

Trial Locations

Locations (1)

Yale Clinical Research; 🇺🇸 New Haven, Connecticut, United States