An interventional study of Cellular Phone Text Messages in HIV and Tuberculosis, sponsored by Massachusetts General Hospital. Completed at 1 site in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-04.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 183 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Participants enrolled in the pre-intervention period (January - August 2012) served as a control group.
Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.
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
Time frame: 28 days
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
Time frame: 28 days
| Milestone | Pre-Intervention Control Group | Intervention Group |
|---|---|---|
| Started | 45 | 138 |
| Completed | 45 | 138 |
| Not completed | 0 | 0 |
Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result
| Participants | Pre-Intervention Control Group | Intervention Period |
|---|---|---|
| Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result | 8 | 89 |
Number of participants who returned to clinic within 28 days of abnormal CD4 count result
| Participants | Pre-Intervention Control Group | Intervention Period |
|---|---|---|
| Clinic Return Within 28 Days of Abnormal CD4 Count Result | 22 | 128 |
Collected over Study participants were monitored until the time of clinic return which extended to a maximum of approximately 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-Intervention Control Group | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Intervention Period | 0/138 (0%) | 0/138 (0%) | 0/138 (0%) |
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.
| Age, Continuous(years) | Pre-Intervention Control Group | Intervention Period | Total |
|---|---|---|---|
| Median | 38 (31 to 44) | 30 (25 to 38) | 32 (26 to 39) |
| Sex/Gender, Customized(Participants) | Pre-Intervention Control Group | Intervention Period | Total |
|---|---|---|---|
| Female Gender | 19 | 75 | 94 |
| Male Gender | 26 | 63 | 89 |
| Region of Enrollment(Participants) | Pre-Intervention Control Group | Intervention Period | Total |
|---|---|---|---|
| Uganda — Mbarara Resident | 32 | 83 | 115 |
| Uganda — Non-Mbarara Resident | 13 | 55 | 68 |
| Number of Antiretroviral Therapy (ART) Naive Participants(Participants) | Pre-Intervention Control Group | Intervention Period | Total |
|---|---|---|---|
| Count of participants | 26 | 110 | 136 |
| Educational Attainment(Participants) | Pre-Intervention Control Group | Intervention Period | Total |
|---|---|---|---|
| <Primary | 3 | 12 | 15 |
| Any primary | 16 | 71 | 87 |
| Any secondary | 12 | 37 | 49 |
| >Secondary | 7 | 18 | 25 |
| Missing Information | 7 | 0 | 7 |
| CD4 Count(cells/mm^3) | Pre-Intervention Control Group | Intervention Period | Total |
|---|---|---|---|
| Median | 185 (106 to 262) | 225 (110 to 293) | 215 (106 to 285) |
| Days from enrollment until laboratory result(Days) | Pre-Intervention Control Group | Intervention Period | Total |
|---|---|---|---|
| Median | 11 (8 to 19) | 10 (8 to 15) | 10 (8 to 16) |
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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