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Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda

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ClinicalTrials.gov Identifier: NCT01579214
Recruitment Status : Completed
First Posted : April 17, 2012
Results First Posted : December 8, 2017
Last Update Posted : January 4, 2018
Mbarara University of Science and Technology
John E. Fogarty International Center (FIC)
Harvard University
Information provided by (Responsible Party):
Mark Siedner, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions: HIV
Intervention: Other: Cellular Phone Text Messages

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Pre-Intervention Control Group Participants followed prior to SMS intervention as a negative control group.
Intervention Group Received a text message stating laboratory results were abnormal and requesting return to clinic.

Participant Flow:   Overall Study
    Pre-Intervention Control Group   Intervention Group
STARTED   45   138 
COMPLETED   45   138 

  Baseline Characteristics

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.
Participants enrolled in the trial were in HIV care and had low CD4 count results requiring a prompt return to clinic as advised by a study clinician.

Reporting Groups
Pre-Intervention Control Group Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation.
Intervention Period

Participants in the intervention period (September 2012 – November 2013) were receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading “ABCDEFG” to confidentially convey an abnormal result.

For our a priori hypothesis, we aimed to test whether clinical outcomes, i.e. time to clinic return and time to ART initiation, were different in the pre-intervention and intervention period. This was a non-randomized allocation.

During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention.

Total Total of all reporting groups

Baseline Measures
   Pre-Intervention Control Group   Intervention Period   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   138   183 
[Units: Years]
Median (Inter-Quartile Range)
 (31 to 44) 
 (25 to 38) 
 (26 to 39) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
Female Gender   19   75   94 
Male Gender   26   63   89 
Region of Enrollment 
[Units: Participants]
Count of Participants
Mbarara Resident      32  71.1%      83  60.1%      115  62.8% 
Non-Mbarara Resident      13  28.9%      55  39.9%      68  37.2% 
Number of Antiretroviral Therapy (ART) Naive Participants 
[Units: Participants]
Count of Participants
 26   110   136 
Educational Attainment 
[Units: Participants]
Count of Participants
<Primary   3   12   15 
Any primary   16   71   87 
Any secondary   12   37   49 
>Secondary   7   18   25 
Missing Information   7   0   7 
CD4 Count 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 (106 to 262) 
 (110 to 293) 
 (106 to 285) 
Days from enrollment until laboratory result 
[Units: Days]
Median (Inter-Quartile Range)
 (8 to 19) 
 (8 to 15) 
 (8 to 16) 

  Outcome Measures

1.  Primary:   Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result   [ Time Frame: 28 days ]

2.  Secondary:   Clinic Return Within 28 Days of Abnormal CD4 Count Result   [ Time Frame: 28 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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
  1. Non-randomized allocation for primary analysis
  2. Single site study
  3. Requires validation in implementation study

  More Information

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: Dr. Mark Siedner
Organization: Massachusetts General Hospital
phone: 617-726-4686 ext 917
e-mail: msiedner@mgh.harvard.edu

Publications of Results:

Responsible Party: Mark Siedner, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01579214     History of Changes
Other Study ID Numbers: 2011P001538
R24TW007988 ( U.S. NIH Grant/Contract )
First Submitted: April 13, 2012
First Posted: April 17, 2012
Results First Submitted: May 5, 2017
Results First Posted: December 8, 2017
Last Update Posted: January 4, 2018