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

NCT ID: NCT01579214

Last Updated: 2018-01-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-04-30

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.

Conditions

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HIV Tuberculosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Cellular Phone Text Messages

Intervention Type OTHER

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

Pre-Intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mbarara University of Science and Technology

OTHER

Sponsor Role collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mark Siedner

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Siedner, MD MPH

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Bosco Bwana, MD

Role: PRINCIPAL_INVESTIGATOR

Mbarara University of Science and Technology

David R Bangsberg, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital Center for Global Health

Jessica Haberer, MD MS

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital Center for Global Health

Locations

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ISS Clinic, Mbarara Regional Referral Hospital

Mbarara, , Uganda

Site Status

Countries

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Uganda

References

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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.

Reference Type RESULT
PMID: 22720901 (View on PubMed)

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.

Reference Type RESULT
PMID: 26149722 (View on PubMed)

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.

Reference Type RESULT
PMID: 25831269 (View on PubMed)

Other Identifiers

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R24TW007988

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2011P001538

Identifier Type: -

Identifier Source: org_study_id

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