- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01579214
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mbarara, Uganda
- ISS Clinic, Mbarara Regional Referral Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
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
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
28 days
|
Collaborators and Investigators
Sponsor
Collaborators
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
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011P001538
- R24TW007988 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.