Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda

Conditions
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HIV, Tuberculosis

Intervention / Treatment
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* Other: Cellular Phone Text Messages


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct Text Message<br>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<br>* Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.<br>|
| No Intervention: Pre-Intervention<br>Participants enrolled in the pre-intervention period (January - August 2012) served as a control group. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Africa south of the sahara, Knowledge of results, Communication barriers, Cellular Phones