Trial Outcomes & Findings for Cell Phone Messaging to Improve Communication of Critical Laboratory Results to Patients in Rural Uganda (NCT 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

Target enrollment

183 participants

Primary outcome timeframe

28 days

Results posted on

2018-01-04

Participant Flow

Participant milestones

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

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=5 Participants	30 years n=7 Participants	32 years n=5 Participants
Sex/Gender, Customized Female Gender	19 Participants n=5 Participants	75 Participants n=7 Participants	94 Participants n=5 Participants
Sex/Gender, Customized Male Gender	26 Participants n=5 Participants	63 Participants n=7 Participants	89 Participants n=5 Participants
Region of Enrollment Uganda · Mbarara Resident	32 Participants n=5 Participants	83 Participants n=7 Participants	115 Participants n=5 Participants
Region of Enrollment Uganda · Non-Mbarara Resident	13 Participants n=5 Participants	55 Participants n=7 Participants	68 Participants n=5 Participants
Number of Antiretroviral Therapy (ART) Naive Participants	26 Participants n=5 Participants	110 Participants n=7 Participants	136 Participants n=5 Participants
Educational Attainment <Primary	3 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants
Educational Attainment Any primary	16 Participants n=5 Participants	71 Participants n=7 Participants	87 Participants n=5 Participants
Educational Attainment Any secondary	12 Participants n=5 Participants	37 Participants n=7 Participants	49 Participants n=5 Participants
Educational Attainment >Secondary	7 Participants n=5 Participants	18 Participants n=7 Participants	25 Participants n=5 Participants
Educational Attainment Missing Information	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
CD4 Count	185 cells/mm^3 n=5 Participants	225 cells/mm^3 n=7 Participants	215 cells/mm^3 n=5 Participants
Days from enrollment until laboratory result	11 Days n=5 Participants	10 Days n=7 Participants	10 Days n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: 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

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 days

Number of participants who returned to clinic within 28 days of abnormal CD4 count result

Outcome measures

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

Dr. Mark Siedner

Massachusetts General Hospital

Phone: 617-726-4686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place