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mHealth Intervention Supporting HIV Treatment Adherence and Retention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01951092
First Posted: September 26, 2013
Last Update Posted: April 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aadia Rana, The Miriam Hospital
Results First Submitted: October 8, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
First Submitted: September 18, 2013
First Posted: September 26, 2013
Results First Submitted: October 8, 2014
Results First Posted: April 22, 2016
Last Update Posted: April 22, 2016



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