Clinical trial NCT04418076: Project SMART Automated Pillbox Study
Official title: Improving Antiretroviral Adherence and Persistence Using mHealth Tools in HIV-infected Cocaine Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Cocaine Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University at Albany
name: University of Connecticut
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-06-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period
timeFrame: Week 12
measure: Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)
timeFrame: Week 16
Secondary outcomes:
measure: Changes in HIV 1 RNA, QN PCR (Copies/ML)
timeFrame: End of intervention (Week 12)
measure: Percent Change in CD4 Count From Baseline to Week 12
timeFrame: Baseline and End of intervention (Week 12)
measure: Retention in Care
timeFrame: up to End of the study (week 16)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Clinical Research
state: Connecticut
Study officials:
affiliation: Yale University
name: Frederick Altice, M.D., M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ranjit YS, Krishnan A, Ghosh D, Cravero C, Zhou X, Altice FL. mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 7;11(3):e28332. doi: 10.2196/28332.