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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579214
• Other study ID #: 2011P001538
• Secondary ID: R24TW007988
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: December 8, 2017
• Start date: July 2012
• Est. completion date: April 2015

Study information

• Verified date: December 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: April 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• HIV
• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
Uganda	ISS Clinic, Mbarara Regional Referral Hospital	Mbarara

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Harvard University, John E. Fogarty International Center (FIC), Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

References & Publications (3)

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. 2 — View Citation

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. — View Citation

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 c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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