HIV/AIDSSMARTNCT04418076
Project SMART Automated Pillbox Study
A study testing Group A_No feedback, Group B_Automated feedback and Group C_Automated feedback + Clinician feedback in people with HIV/AIDS and Cocaine Use, run by Yale University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Cocaine Use
- What is being tested?
- Group A_No feedback, Group B_Automated feedback and Group C_Automated feedback + Clinician feedback
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2017to 18 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- Verbally or physically threatening to research staff
- Unable to communicate in either English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Clinical Research
New Haven, Connecticut, 06510
About this study
Official title: Improving Antiretroviral Adherence and Persistence Using mHealth Tools in HIV-infected Cocaine Users
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).
Read the 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).
- Conditions
- HIV/AIDS, Cocaine Use
- Being tested
- Group A_No feedback, Group B_Automated feedback, Group C_Automated feedback + Clinician feedback, Group D_Automated feedback + Social Network feedback
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| No feedback | Experimental | For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given. Receives: Device: Group A_No feedback |
| Automated feedback | Experimental | 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. Receives: Device: Group B_Automated feedback |
| Automated feedback + Clinician feedback | Experimental | 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. Receives: Device: Group C_Automated feedback + Clinician feedback |
| Automated feedback + Social Network feedback | Experimental | 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. Receives: Device: Group D_Automated feedback + Social Network feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period
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.
Measured: Week 12
Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)
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.
Measured: Week 16
Secondary outcomes (3)
Changes in HIV 1 RNA, QN PCR (Copies/ML)
HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.
Measured: End of intervention (Week 12)
Percent Change in CD4 Count From Baseline to 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.
Measured: Baseline and End of intervention (Week 12)
Retention in Care
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).
Measured: up to End of the study (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start8 Jun 2017
- Primary completion18 Aug 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University at Albany, University of Connecticut, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Frederick Altice, M.D., M.A., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418076
- Sponsor's protocol ID
- 1508016342
- Other IDs
- 1R21DA039842-01A1
- Acronym
- SMART
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2018
- Last updated
- 15 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be kept confidential.
Publications
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.
PubMed 35254270
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Antiretroviral Adherence and Persistence Using mHealth Tools in HIV-infected Cocaine Users
- ClinicalTrials.gov ID
- NCT04418076
- Acronym / sponsor ID
- SMART / 1508016342
- Conditions
- HIV/AIDS, Cocaine Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University at Albany, University of Connecticut, National Institute on Drug Abuse (NIDA)
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 18 Aug 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 15 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No feedback | Experimental | Device: Group A_No feedbackFor participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given. |
| Automated feedback | Experimental | Device: Group B_Automated feedbackFor 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. |
| Automated feedback + Clinician feedback | Experimental | Device: Group C_Automated feedback + Clinician feedbackFor 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 | Experimental | Device: Group D_Automated feedback + Social Network feedbackFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Verbally or physically threatening to research staff
- Unable to communicate in either English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group A_No feedbackIn 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. | Device | No feedback |
| Group B_Automated feedbackFor 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. | Device | Automated feedback |
| Group C_Automated feedback + Clinician feedbackFor 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. | Device | Automated feedback + Clinician feedback |
| Group D_Automated feedback + Social Network feedbackFor 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. | Device | Automated feedback + Social Network feedback |
Primary outcome
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.
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.
3 secondary outcomes
Changes in HIV 1 RNA, QN PCR (Copies/ML)
Time frame: End of intervention (Week 12)
Percent Change in CD4 Count From Baseline to Week 12
Time frame: Baseline and End of intervention (Week 12)
Retention in Care
Time frame: up to End of the study (week 16)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35254270Ranjit 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.
- Individual participant dataSharing planned: No. All data will be kept confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Altice, M.D., M.A. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A_No feedback, Group B_Automated feedback and Group C_Automated feedback + Clinician feedback in people with HIV/AIDS and Cocaine Use, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.