mHealth Intervention Supporting HIV Treatment Adherence and Retention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aadia Rana, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01951092
First received: September 18, 2013
Last updated: April 11, 2016
Last verified: April 2016
Results First Received: October 8, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: HIV
Adherence
Retention
Intervention: Other: Text messaging

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Patients at the Immunology Center in Providence RI who were either 1) newly diagnosed, 2) returning to care after a gap, 3) or with difficulties with adherence to care were eligible for enrollment in this pilot study.

Participants were recruited from January 2013 through July 2013 and followed for 6 months.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Single Arm Intervention Study

All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.

Text messaging


Participant Flow:   Overall Study
    Single Arm Intervention Study  
STARTED     32  
COMPLETED     20  
NOT COMPLETED     12  
Lost to Follow-up                 10  
Incarceration                 1  
Transfer of Care                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Single Arm Intervention Study All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.

Baseline Measures
    Single Arm Intervention Study  
Number of Participants  
[units: participants]
  32  
Age  
[units: years]
Median (Full Range)
  36  
  (19 to 64)  
Gender  
[units: participants]
 
Female     10  
Male     22  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     7  
White     20  
More than one race     2  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     32  
Participants with HIV PVL <200 copies/mL [1]
[units: participants]
  18  
[1] Number of patients with baseline HIV PVL <200 copies/mL



  Outcome Measures
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1.  Primary:   Number of Particpatns Who Considered the Intervention Feasible and Acceptable   [ Time Frame: 6 months ]

2.  Secondary:   Efficacy   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aadia Rana, MD
Organization: Alpert Medical School of Brown University/The Miriam Hospital
phone: 401-793-4680
e-mail: arana@lifespan.org



Responsible Party: Aadia Rana, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT01951092     History of Changes
Other Study ID Numbers: Lifespan Dev Grant Rana-2012
Study First Received: September 18, 2013
Results First Received: October 8, 2014
Last Updated: April 11, 2016
Health Authority: United States: The Miriam Hospital Institutional Review Board
United States: mHealth study Data Safety Monitoring Board