ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

April 13, 2012
April 17, 2012
May 5, 2017
December 8, 2017
January 4, 2018
July 2012
December 2013   (Final data collection date for primary outcome measure)
Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result [ Time Frame: 28 days ]
Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result
Receipt and comprehension of health-related text message [ Time Frame: 28 days ]
Complete list of historical versions of study NCT01579214 on ClinicalTrials.gov Archive Site
Clinic Return Within 28 Days of Abnormal CD4 Count Result [ Time Frame: 28 days ]
Number of participants who returned to clinic within 28 days of abnormal CD4 count result
Return to clinic [ Time Frame: 14 days from test result ]
Not Provided
Not Provided
 
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
The investigators will study the efficacy of a novel cellular phone messaging system to communicate health information and facilitate early return to clinic after abnormal laboratory results in rural Uganda.

Among the challenges that complicate optimal health care delivery in rural settings is lack of communication between care providers and patients. Communication of abnormal laboratory results represents a particular challenge. Laboratory and other test results are often not reported until repeat visits weeks to months later. In the case of treatment failure, severe treatment complications, or evidence of opportunistic infection, such reporting delays likely result in adverse outcomes and potentially compromise future treatment options. The investigators propose to evaluate a novel strategy of communication using SMS text messaging to facilitate patient return to an HIV clinic in Uganda after critical laboratory results.

The investigators will consent and enroll participants at the time of laboratory testing for cluster of differentiation 4 (CD4) count, viral loads, acid fast bacteria smears of sputum, among others. Those with abnormal results will be randomized to various messaging formats and receive text messages requesting a prompt return to clinic. For outcomes, the investigators will measure successful receipt and comprehension of messages, as well as proportion returning within 14 days of the abnormal laboratory test.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

This is a quasi-experimental design study with two periods of study. The pre-intervention period serves as the control group. During the intervention period, participants received one of three message types to be informed of their test results: 1) a standard message informing their abnormal result, 2) the standard message protected by a PIN number code, and 3) a coded texted message "ABCDEFG."

For our a priori hypotheses about the effect of receiving an SMS message on outcomes, we compared results for participants in the pre-intervention period with all those in the post-intervention period. This was a non-randomized intervention.

For our primary outcome (time to ART initiation) we assessed all participants with abnormal CD4 count results who were ART-naive at study enrollment. For our secondary outcome (time to clinic return) we looked at all study participants with abnormal CD4 counts.

Masking: None (Open Label)
Primary Purpose: Health Services Research
  • HIV
  • Tuberculosis
Other: Cellular Phone Text Messages
Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.
  • Active Comparator: Direct Text Message
    Participants in the intervention period (September 2012 - November 2013) received daily short message service (SMS) messages for up to seven days with messages reporting an abnormal result
    Intervention: Other: Cellular Phone Text Messages
  • No Intervention: Pre-Intervention
    Participants enrolled in the pre-intervention period (January - August 2012) served as a control group.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
250
April 2015
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV positive
  • Active in care at Mbarara Regional Referral Hospital HIV Clinic
  • Undergoing laboratory testing
  • Self-reported cell phone access
  • Agrees to participation and gives informed consent

Exclusion Criteria:

  • Age < 18
  • Resides outside great Mbarara area (Mbarara, Isingiro, Kyruhuura, Ibanda, or Ntungamo districts)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
 
NCT01579214
2011P001538
R24TW007988 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Mark Siedner, Massachusetts General Hospital
Massachusetts General Hospital
  • Mbarara University of Science and Technology
  • John E. Fogarty International Center (FIC)
  • Harvard University
Study Director: Mark Siedner, MD MPH Massachusetts General Hospital
Principal Investigator: Bosco Bwana, MD Mbarara University of Science and Technology
Principal Investigator: David R Bangsberg, MD MPH Massachusetts General Hospital Center for Global Health
Principal Investigator: Jessica Haberer, MD MS Massachusetts General Hospital Center for Global Health
Massachusetts General Hospital
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP