Trial Outcomes & Findings for Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda (NCT NCT01579214)
NCT ID: NCT01579214
Last Updated: 2018-01-04
Results Overview
Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
183 participants
Primary outcome timeframe
28 days
Results posted on
2018-01-04
Participant Flow
Participant milestones
| Measure |
Pre-Intervention Control Group
Participants followed prior to SMS intervention as a negative control group.
|
Intervention Group
Received a text message stating laboratory results were abnormal and requesting return to clinic.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
138
|
|
Overall Study
COMPLETED
|
45
|
138
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda
Baseline characteristics by cohort
| Measure |
Pre-Intervention Control Group
n=45 Participants
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.
|
Intervention Period
n=138 Participants
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.
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=99 Participants
|
30 years
n=107 Participants
|
32 years
n=206 Participants
|
|
Sex/Gender, Customized
Female Gender
|
19 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male Gender
|
26 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Region of Enrollment
Uganda · Mbarara Resident
|
32 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Region of Enrollment
Uganda · Non-Mbarara Resident
|
13 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Number of Antiretroviral Therapy (ART) Naive Participants
|
26 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Educational Attainment
<Primary
|
3 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Educational Attainment
Any primary
|
16 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Educational Attainment
Any secondary
|
12 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Educational Attainment
>Secondary
|
7 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Educational Attainment
Missing Information
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
CD4 Count
|
185 cells/mm^3
n=99 Participants
|
225 cells/mm^3
n=107 Participants
|
215 cells/mm^3
n=206 Participants
|
|
Days from enrollment until laboratory result
|
11 Days
n=99 Participants
|
10 Days
n=107 Participants
|
10 Days
n=206 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: These are participants who were Antiretroviral Therapy naive, and so analysis of this measurement is using this subgroup only.
Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result
Outcome measures
| Measure |
Pre-Intervention Control Group
n=26 Participants
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.
|
Intervention Period
n=110 Participants
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.
|
|---|---|---|
|
Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result
|
8 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of participants who returned to clinic within 28 days of abnormal CD4 count result
Outcome measures
| Measure |
Pre-Intervention Control Group
n=45 Participants
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.
|
Intervention Period
n=138 Participants
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.
|
|---|---|---|
|
Clinic Return Within 28 Days of Abnormal CD4 Count Result
|
22 Participants
|
128 Participants
|
Adverse Events
Pre-Intervention Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place