N/A N=78 Randomized Other

Project SMART Automated Pillbox Study

HIV/AIDS · Cocaine Use

Bottom Line

View on ClinicalTrials.gov: NCT04418076 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period — 91.07; 96.00; 99.82; 94.81 percentage of times pills taken

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Group A_No feedback (Device); Group B_Automated feedback (Device); Group C_Automated feedback + Clinician feedback (Device); Group D_Automated feedback + Social Network feedback (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period	91.07; 96.00; 99.82; 94.81	—
PRIMARY Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)	96.31; 93.00; 92.75; 93.24	—
SECONDARY Changes in HIV 1 RNA, QN PCR (Copies/ML)	0; 2; 2; 0; 0; 2	—
SECONDARY Percent Change in CD4 Count From Baseline to Week 12	27.00; 26.09; 28.8; 30.81	—
SECONDARY Retention in Care	—	—

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).

Eligibility Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04418076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.