NCT04418076

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2020

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 15, 2023

Completed
Last Updated

May 15, 2023

Status Verified

April 1, 2023

Enrollment Period

3.2 years

First QC Date

March 16, 2018

Results QC Date

May 13, 2021

Last Update Submit

April 20, 2023

Conditions

HIV/AIDSCocaine Use

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Week 16

Secondary Outcomes (3)

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

    End of intervention (Week 12)

  • Percent Change in CD4 Count From Baseline to Week 12

    Baseline and End of intervention (Week 12)

  • Retention in Care

    up to End of the study (week 16)

Study Arms (4)

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.

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.

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.

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.

Device: Group D_Automated feedback + Social Network feedback

Interventions

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.

No feedback
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.

Automated feedback
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.

Automated feedback + Clinician feedback
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.

Automated feedback + Social Network feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale Clinical Research

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 35254270DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Results Point of Contact

Title
Natalie Kil
Organization
Associate Director Domestic Projects
natalie.kil@yale.edu
203.737.2883

Study Officials

  • Frederick Altice, M.D., M.A.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

June 5, 2020

Study Start

June 8, 2017

Primary Completion

August 18, 2020

Study Completion

August 18, 2020

Last Updated

May 15, 2023

Results First Posted

May 15, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

All data will be kept confidential.

Locations

US(1)