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| ID | Type | Description | Link |
|---|---|---|---|
| R24TW007988 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mbarara University of Science and Technology | OTHER |
| Fogarty International Center of the National Institute of Health | NIH |
| Harvard University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Pre-Intervention | No Intervention | Participants enrolled in the pre-intervention period (January - August 2012) served as a control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISS Clinic, Mbarara Regional Referral Hospital | Mbarara | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22720901 | Result | 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. | |
| 26149722 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Intervention Control Group | Participants followed prior to SMS intervention as a negative control group. |
| FG001 | Intervention Group | Received a text message stating laboratory results were abnormal and requesting return to clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants enrolled in the trial were in HIV care and had low CD4 count results requiring a prompt return to clinic as advised by a study clinician.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Intervention Control Group | Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | These are participants who were Antiretroviral Therapy naive, and so analysis of this measurement is using this subgroup only. | Posted | Count of Participants | Participants | 28 days |
|
Study participants were monitored until the time of clinic return which extended to a maximum of approximately 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Intervention Control Group | Eligible participants from a pre-intervention period (January-August 2012) prior to their receiving SMS messages about their laboratory test results. During the pre-intervention stage, clinicians completed eligibility forms for each participant, including confirmation of access to a cellular phone, district of residence, and selection of the abnormal result threshold for the cluster of differentiation 4 (CD4) test, which would prompt a request for an early return to clinic. Standard clinical forms were completed to collect data on sociodemographic and clinical characteristics. We also collected data on the laboratory result and result date, time from laboratory result to clinic return, and for antiretroviral therapy (ART) naive participants, time to ART initiation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Siedner | Massachusetts General Hospital | 617-726-4686 | 917 | msiedner@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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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.
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| 25831269 | 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. |
| BG001 | Intervention Period | Participants in the intervention period (September 2012 - November 2013) were receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading "ABCDEFG" to confidentially convey an abnormal result. For our a priori hypothesis, we aimed to test whether clinical outcomes, i.e. time to clinic return and time to ART initiation, were different in the pre-intervention and intervention period. This was a non-randomized allocation. During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Number of Antiretroviral Therapy (ART) Naive Participants | Count of Participants | Participants |
|
| Educational Attainment | Count of Participants | Participants |
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| CD4 Count | Median | Inter-Quartile Range | cells/mm^3 |
|
| Days from enrollment until laboratory result | Median | Inter-Quartile Range | Days |
|
| OG001 | Intervention Period | Participants in the intervention period (September 2012 - November 2013) were receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading "ABCDEFG" to confidentially convey an abnormal result. For our a priori hypothesis, we aimed to test whether clinical outcomes, i.e. time to clinic return and time to ART initiation, were different in the pre-intervention and intervention period. This was a non-randomized allocation. During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention. |
|
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| 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 | Posted | Count of Participants | Participants | 28 days |
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|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Intervention Period | Participants in the intervention period (September 2012 - November 2013) were randomized to receive daily short message service (SMS) messages for up to seven days in one of three formats: 1) messages reporting an abnormal result directly, 2) personal identification number-protected messages reporting an abnormal result, or 3) messages reading "ABCDEFG" to confidentially convey an abnormal result. During the intervention period, clinicians used eligibility criteria identical to those used during the pre-intervention period, including selection of an abnormal cluster of differentiation 4 (CD4) count threshold to trigger the SMS and transportation reimbursement intervention. | 0 | 138 | 0 | 138 | 0 | 138 |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |