Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
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Purpose
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.
| Condition | Intervention |
|---|---|
|
HIV Tuberculosis |
Other: Cellular Phone Text Message Formats |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
- Receipt and comprehension of health-related text message [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Return to clinic [ Time Frame: 14 days from test result ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Direct Text Message |
Other: Cellular Phone Text Message Formats
Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.
|
| Active Comparator: Direct Text Message+PIN-code activation |
Other: Cellular Phone Text Message Formats
Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.
|
| Active Comparator: Coded Text Message |
Other: Cellular Phone Text Message Formats
Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Contact: Mark Siedner, MD, MPH | 256-77-846-9619 | msiedner@partners.org |
| Contact: Bosco Bwana, MD | 256-77-230-8895 | mwebesa_bwana@yahoo.com |
| Uganda | |
| ISS Clinic, Mbarara Regional Referral Hospital | Recruiting |
| Mbarara, Uganda | |
| Contact: Bosco Bwana, MD 256-77-230-8895 mwbesa_bwana@yahoo.com | |
| Study Director: | Mark Siedner, MD MPH | Massachusetts General Hospital |
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | David Bangsberg, MD, Associate Professor of Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01579214 History of Changes |
| Other Study ID Numbers: | CP-002, R24TW007988 |
| Study First Received: | April 13, 2012 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Institutional Review Board Uganda: National Council for Science and Technology |
Keywords provided by Massachusetts General Hospital:
|
HIV Africa south of the sahara Knowledge of results Communication barriers Cellular Phones |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on June 18, 2013