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

NCT01579214 | Completed Results

• 2 other identifiers: 2011P001538R24TW007988
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Tuberculosis

Keywords

HIV; Africa south of the sahara; Knowledge of results; Communication barriers; Cellular Phones

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinic Return Within 28 Days of Abnormal CD4 Count Result

  28 days

Study Arms (2)

Direct Text Message

ACTIVE COMPARATOR

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

Pre-Intervention

NO INTERVENTION

Participants enrolled in the pre-intervention period (January - August 2012) served as a control group.

Interventions

Cellular Phone Text Messages OTHER

Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.

Direct Text Message

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \< 18
• Resides outside great Mbarara area (Mbarara, Isingiro, Kyruhuura, Ibanda, or Ntungamo districts)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mbarara University of Science and Technology: collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• Harvard University: collaborator

Study Sites (1)

ISS Clinic, Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

Related 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. 2012 Jun 21;12:56. doi: 10.1186/1472-6947-12-56.

  PMID: 22720901 RESULT

• 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.

  PMID: 26149722 RESULT

• 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.

  PMID: 25831269 RESULT

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Limitations and Caveats

1. Non-randomized allocation for primary analysis 2. Single site study 3. Requires validation in implementation study

Results Point of Contact

• Title: Dr. Mark Siedner
• Organization: Massachusetts General Hospital

msiedner@mgh.harvard.edu

617-726-4686

Study Officials

• Mark Siedner, MD MPH

  Massachusetts General Hospital

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 17, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2015
• Last Updated: January 4, 2018
• Results First Posted: December 8, 2017

Record last verified: 2017-12

Locations

UG (1)