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

Primary Purpose

HIV, Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Cellular Phone Text Messages
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV focused on measuring HIV, Africa south of the sahara, Knowledge of results, Communication barriers, Cellular Phones

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • ISS Clinic, Mbarara Regional Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Direct Text Message

Pre-Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 13, 2012
Last Updated
December 8, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Mbarara University of Science and Technology, Fogarty International Center of the National Institute of Health, Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT01579214
Brief Title
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Official Title
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Mbarara University of Science and Technology, Fogarty International Center of the National Institute of Health, Harvard University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Tuberculosis
Keywords
HIV, Africa south of the sahara, Knowledge of results, Communication barriers, Cellular Phones

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct Text Message
Arm Type
Active Comparator
Arm Description
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
Arm Title
Pre-Intervention
Arm Type
No Intervention
Arm Description
Participants enrolled in the pre-intervention period (January - August 2012) served as a control group.
Intervention Type
Other
Intervention Name(s)
Cellular Phone Text Messages
Intervention Description
Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.
Primary Outcome Measure Information:
Title
Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result
Description
Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Clinic Return Within 28 Days of Abnormal CD4 Count Result
Description
Number of participants who returned to clinic within 28 days of abnormal CD4 count result
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Siedner, MD MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bosco Bwana, MD
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David R Bangsberg, MD MPH
Organizational Affiliation
Massachusetts General Hospital Center for Global Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica Haberer, MD MS
Organizational Affiliation
Massachusetts General Hospital Center for Global Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
ISS Clinic, Mbarara Regional Referral Hospital
City
Mbarara
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
22720901
Citation
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.
Results Reference
result
PubMed Identifier
26149722
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 cohort study. BMC Med. 2015 Jul 6;13:160. doi: 10.1186/s12916-015-0397-1.
Results Reference
result
PubMed Identifier
25831269
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.
Results Reference
result

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

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