Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01579214|
Recruitment Status : Completed
First Posted : April 17, 2012
Results First Posted : December 8, 2017
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Tuberculosis||Other: Cellular Phone Text Messages||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||183 participants|
|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|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||April 2015|
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.
- 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
- 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
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|
|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|