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Completed

NCT Number: NCT04418076

Project SMART Automated Pillbox Study

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).

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Cocaine Use Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Clinical Research

New Haven, Connecticut, 06510, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A_No feedback

Device

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 feedback

Device

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 feedback

Device

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 feedback

Device

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.

Primary outcomes

  1. Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period

    Time frame: 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.

  2. Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)

    Time frame: 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 outcomes

  1. Changes in HIV 1 RNA, QN PCR (Copies/ML)

    Time frame: End of intervention (Week 12)

    HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.

  2. Percent Change in CD4 Count From Baseline to Week 12

    Time frame: 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.

  3. Retention in Care

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)
  • University at Albany
  • University of Connecticut

Registry information

Official study title

Improving Antiretroviral Adherence and Persistence Using mHealth Tools in HIV-infected Cocaine Users

Acronym: SMART

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 5, 2020
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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