HIV, Tuberculosis
Conditions
Keywords
HIV, Africa south of the sahara, Knowledge of results, Communication barriers, Cellular Phones
Brief summary
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.
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 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.
Interventions
OTHERCellular Phone Text Messages
Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.
Sponsors
Mbarara University of Science and Technology
Fogarty International Center of the National Institute of Health
Harvard University
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result | 28 days | Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinic Return Within 28 Days of Abnormal CD4 Count Result | 28 days | Number of participants who returned to clinic within 28 days of abnormal CD4 count result |
Countries
Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 138 |
| Total | 183 |
Baseline characteristics
| Characteristic | Intervention Period | Total | Pre-Intervention Control Group |
|---|---|---|---|
| Age, Continuous | 30 years | 32 years | 38 years |
| CD4 Count | 225 cells/mm^3 | 215 cells/mm^3 | 185 cells/mm^3 |
| Days from enrollment until laboratory result | 10 Days | 10 Days | 11 Days |
| Educational Attainment Any primary | 71 Participants | 87 Participants | 16 Participants |
| Educational Attainment Any secondary | 37 Participants | 49 Participants | 12 Participants |
| Educational Attainment Missing Information | 0 Participants | 7 Participants | 7 Participants |
| Educational Attainment <Primary | 12 Participants | 15 Participants | 3 Participants |
| Educational Attainment >Secondary | 18 Participants | 25 Participants | 7 Participants |
| Number of Antiretroviral Therapy (ART) Naive Participants | 110 Participants | 136 Participants | 26 Participants |
| Region of Enrollment Uganda Mbarara Resident | 83 Participants | 115 Participants | 32 Participants |
| Region of Enrollment Uganda Non-Mbarara Resident | 55 Participants | 68 Participants | 13 Participants |
| Sex/Gender, Customized Female Gender | 75 Participants | 94 Participants | 19 Participants |
| Sex/Gender, Customized Male Gender | 63 Participants | 89 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 138 |
| other Total, other adverse events | 0 / 45 | 0 / 138 |
| serious Total, serious adverse events | 0 / 45 | 0 / 138 |
Outcome results
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
Time frame: 28 days
Population: These are participants who were Antiretroviral Therapy naive, and so analysis of this measurement is using this subgroup only.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Intervention Control Group | Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result | 8 Participants |
| Intervention Period | Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result | 89 Participants |
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
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-Intervention Control Group | Clinic Return Within 28 Days of Abnormal CD4 Count Result | 22 Participants |
| Intervention Period | Clinic Return Within 28 Days of Abnormal CD4 Count Result | 128 Participants |