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
  Purpose

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.


Condition Intervention
HIV
Tuberculosis
Other: Cellular Phone Text Message Formats

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Receipt and comprehension of health-related text message [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Return to clinic [ Time Frame: 14 days from test result ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2012
Estimated Study Completion Date: February 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Direct Text Message 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+PIN-code activation 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: Coded Text Message 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579214

Locations
Uganda
ISS Clinic, Mbarara Regional Referral Hospital
Mbarara, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
Mbarara University of Science and Technology
Harvard Global Health Institute
Investigators
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
  More Information

No publications provided

Responsible Party: David Bangsberg, MD, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01579214     History of Changes
Other Study ID Numbers: CP-002, R24TW007988
Study First Received: April 13, 2012
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board
Uganda: National Council for Science and Technology

Keywords provided by Massachusetts General Hospital:
HIV
Africa south of the sahara
Knowledge of results
Communication barriers
Cellular Phones

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 18, 2014