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.

Study Overview

• Status: Completed
• Conditions: HIV; Tuberculosis
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Mbarara, Uganda
    • ISS Clinic, Mbarara Regional Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result	Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinic Return Within 28 Days of Abnormal CD4 Count Result	Number of participants who returned to clinic within 28 days of abnormal CD4 count result	28 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Fogarty International Center of the National Institute of Health; Harvard University; Mbarara University of Science and Technology
• 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

Publications and helpful links

General Publications

• Siedner MJ, Haberer JE, Bwana MB, Ware NC, Bangsberg DR. High acceptability for cell phone text messages to improve communication of laboratory results with HIV-infected patients in rural Uganda: a cross-sectional survey study. BMC Med Inform Decis Mak. 2012 Jun 21;12:56. doi: 10.1186/1472-6947-12-56.
• Siedner MJ, Santorino D, Lankowski AJ, Kanyesigye M, Bwana MB, Haberer JE, Bangsberg DR. A combination SMS and transportation reimbursement intervention to improve HIV care following abnormal CD4 test results in rural Uganda: a prospective observational cohort study. BMC Med. 2015 Jul 6;13:160. doi: 10.1186/s12916-015-0397-1.
• Siedner MJ, Santorino D, Haberer JE, Bangsberg DR. Know your audience: predictors of success for a patient-centered texting app to augment linkage to HIV care in rural Uganda. J Med Internet Res. 2015 Mar 24;17(3):e78. doi: 10.2196/jmir.3859.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: April 13, 2012
• First Submitted That Met QC Criteria: April 16, 2012
• First Posted (Estimate): April 17, 2012

Study Record Updates

• Last Update Posted (Actual): January 4, 2018
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: HIV; Africa south of the sahara; Knowledge of results; Communication barriers; Cellular Phones
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 2011P001538; R24TW007988 (U.S. NIH Grant/Contract)