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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
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Tuberculosis Other: Cellular Phone Text Messages

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 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
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
Official Title: Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Study Start Date : July 2012
Primary Completion Date : December 2013
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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.
No Intervention: Pre-Intervention
Participants enrolled in the pre-intervention period (January - August 2012) served as a control group.

Outcome Measures

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579214

ISS Clinic, Mbarara Regional Referral Hospital
Mbarara, Uganda
Sponsors and Collaborators
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
More Information

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

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

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