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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Mbarara University of Science and Technology
Harvard Global Health Institute
Information provided by (Responsible Party):
David Bangsberg, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01579214
First received: April 13, 2012
Last updated: January 14, 2014
Last verified: January 2014

April 13, 2012
January 14, 2014
July 2012
December 2013   (final data collection date for primary outcome measure)
Receipt and comprehension of health-related text message [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01579214 on ClinicalTrials.gov Archive Site
Return to clinic [ Time Frame: 14 days from test result ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Not Provided

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 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 Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • HIV
  • Tuberculosis
Other: Cellular Phone Text Message Formats
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
    Intervention: Other: Cellular Phone Text Message Formats
  • Active Comparator: Direct Text Message+PIN-code activation
    Intervention: Other: Cellular Phone Text Message Formats
  • Active Comparator: Coded Text Message
    Intervention: Other: Cellular Phone Text Message Formats
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
February 2014
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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT01579214
CP-002, R24TW007988
No
David Bangsberg, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Mbarara University of Science and Technology
  • John E. Fogarty International Center (FIC)
  • Harvard Global Health Institute
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
January 2014

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