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

Not Applicable

Completed

• Conditions: Tuberculosis; HIV
• Interventions: Other: Cellular Phone Text Messages

• Registration Number: NCT01579214
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Study Start: 2012-07
• Primary Completion: 2013-12
• Study Completion: 2015-04
• Results First Submitted: 2017-05-05
• Results First Submitted QC: 2017-10-17
• Status Verified: 2017-12
• Results First Posted: 2017-12-08
• Last Update Submitted: 2017-12-08
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct Text Message	Cellular Phone Text Messages	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

Primary Outcome Measures

Name	Time	Method
Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result	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

Name	Time	Method
Clinic Return Within 28 Days of Abnormal CD4 Count Result	28 days	Number of participants who returned to clinic within 28 days of abnormal CD4 count result

Trial Locations

Locations (1)

ISS Clinic, Mbarara Regional Referral Hospital; 🇺🇬 Mbarara, Uganda