HIV
Conditions
Keywords
HIV-positive, adherence, engagement to care, mobile Health (mHealth), SMS, peer navigation, retention
Brief summary
This study will evaluate the efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care, and adherence to medication for HIV positive individuals in South Africa: short message service (SMS) text messaging and peer navigation services.
Detailed description
Treatment-as-prevention represents a game changing potential to stem further HIV transmission by ensuring that infected individuals are tested, linked to care, retained in care, and adherent to their regimens. Little is known, however, about the most feasible and cost-effective means to promote overall engagement in care coupled with behavioral risk reduction for HIV positive individuals in South Africa. For this reason, the study proposes to first assess what engagement in care activities are underway in select clinics in the Bojanala Platinum District, North West Province, South Africa, and will then implement and evaluate the feasibility, acceptability, and potential efficacy of two strategies for enhancing overall preventive behaviors, retention in HIV care and adherence to medication. The first strategy will employ automated text message reminders to encourage patients to return for needed care, adhere to their antiretroviral therapy (ART) regimens, and practice safer sex and other risk reduction behaviors. This approach also includes designation of a retention, adherence, and prevention monitor to supervise the system. A second strategy builds on the first model, including the automated text message system, but also utilizes peer navigator-provider teams to serve as point people for care engagement. Peer navigators will work with providers to introduce patients to care and help them establish a care and prevention plan. They will also check in with patients to discuss and support resolution of challenges to engaging in care, adhering to drug regimens, and reducing transmission risk behavior.
Interventions
BEHAVIORALSMS text message
bi-weekly behavioral messages and bi-weekly check-in messages
BEHAVIORALSMS text message + Peer Navigation
bi-weekly behavioral messages plus personalized peer navigation
Sponsors
University of Washington
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV positive (diagnosed within the last 12 months prior to study/patient contact) * Has access to a mobile phone * Willing to receive and respond to text messages and calls from clinic and study staff (all arms) * Willing to communicate and meet with PN (PN arm) * Willing to meet with study staff for survey at study start, 6 months, and 12 months (all arms) * regard study clinic area as the regular clinic for accessing healthcare
Exclusion criteria
* First tested positive over 12 months prior to recruitment * Under the age of 18 * Unable to give informed consent * Unable to read basic English and with no one to read study sms to participant * Principally accesses care through a clinic not in the study * Planning to permanently move away from the area served by the clinic within next 6 months (following enrollment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) | 3 months | Participants who received CD4 count test result within 3 months of testing HIV-positive (binary) |
| Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) | 3 months | Participants eligible for ART who initiate treatment within 3 months of diagnosis |
| Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) | 12 months | Participants eligible for ART who initiated ART and who remain on treatment 12 months from enrollment. Retention in care at 12 months is defined as at least 4 clinical care visits with less than 4 months between each visit. |
| Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) | 12 months | Participants who return for repeat CD4 testing within 12 months of diagnosis |
| Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) | 12 months | Viral load test results \<400 copies/mL (consistent with current and correct adherence to ART) |
| Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) | 12 months | Self-reported ability to take ART as prescribed in last month, assessed at 12 months from enrollment. Considered compliant if reported very good or excellent adherence. |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime) only. This group will not receive any additional engagement to care intervention. | 167 |
| SMS Text Message Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also automated bi-weekly check-in text messages that will trigger a phone call from clinic staff if the participant reports not being well.
SMS text message: bi-weekly behavioral messages and bi-weekly check-in messages | 289 |
| SMS Text Message + Peer Navigation Participants are administered baseline, 6 month, and 12 month questionnaires and provided with the study incentive (mobile phone airtime). In addition, they receive automated bi-weekly behavioral text messages aimed at improving health and reducing transmission risk and also bi-weekly contact from an HIV-positive peer who provides personalized support and with health or other service systems navigation assistance.
SMS text message + Peer Navigation: bi-weekly behavioral messages plus personalized peer navigation | 296 |
| Total | 752 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 4 | 10 | 14 |
| Overall Study | Lost to Follow-up | 27 | 39 | 34 |
| Overall Study | Mentally unstable | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 0 | 2 |
| Overall Study | Relocation out of study area | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 8 |
Baseline characteristics
| Characteristic | Standard of Care | SMS Text Message | SMS Text Message + Peer Navigation | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 167 Participants | 289 Participants | 294 Participants | 750 Participants |
| Race/Ethnicity, Customized Black | 166 Participants | 288 Participants | 295 Participants | 749 Participants |
| Race/Ethnicity, Customized Colored | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 70 Participants | 116 Participants | 106 Participants | 292 Participants |
| Sex: Female, Male Male | 97 Participants | 173 Participants | 190 Participants | 460 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 169 | 10 / 289 | 14 / 298 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)
Viral load test results \<400 copies/mL (consistent with current and correct adherence to ART)
Time frame: 12 months
Population: Analysis population is all enrolled participants who were prescribed ART and had received viral load testing by 12 months of study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) | 67 Participants |
| Short Message Service (SMS) Text Message | Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) | 141 Participants |
| SMS Text Message + Peer Navigation | Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) | 132 Participants |
p-value: 0.09395% CI: [0.9, 4.21]Regression, Logistic
p-value: 0.15295% CI: [0.81, 3.83]Regression, Logistic
Primary
Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)
Self-reported ability to take ART as prescribed in last month, assessed at 12 months from enrollment. Considered compliant if reported very good or excellent adherence.
Time frame: 12 months
Population: Analysis population is all enrolled participants prescribed ART who returned to answer the 12 month survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) | 92 Participants |
| Short Message Service (SMS) Text Message | Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) | 130 Participants |
| SMS Text Message + Peer Navigation | Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) | 162 Participants |
Primary
Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary)
Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)
Time frame: 3 months
Population: Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) | 80 Participants |
| Short Message Service (SMS) Text Message | Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) | 121 Participants |
| SMS Text Message + Peer Navigation | Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) | 119 Participants |
p-value: 0.84895% CI: [0.62, 1.49]Regression, Logistic
p-value: 0.12595% CI: [0.9, 2.49]Regression, Logistic
Primary
Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)
Participants eligible for ART who initiated ART and who remain on treatment 12 months from enrollment. Retention in care at 12 months is defined as at least 4 clinical care visits with less than 4 months between each visit.
Time frame: 12 months
Population: Analysis population is all enrolled participants who were prescribed ART.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) | 77 Participants |
| Short Message Service (SMS) Text Message | Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) | 153 Participants |
| SMS Text Message + Peer Navigation | Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) | 178 Participants |
p-value: 0.1695% CI: [0.86, 2.55]Regression, Logistic
p-value: 0.0395% CI: [1.06, 3.14]Regression, Logistic
Primary
Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)
Participants who return for repeat CD4 testing within 12 months of diagnosis
Time frame: 12 months
Population: Analysis population is all enrolled participants who were not prescribed ART
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) | 3 Participants |
| Short Message Service (SMS) Text Message | Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) | 2 Participants |
| SMS Text Message + Peer Navigation | Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) | 11 Participants |
p-value: 0.2495% CI: [0.03, 2.45]Regression, Logistic
p-value: 0.295% CI: [0.59, 12.16]Regression, Logistic
Primary
Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)
Participants eligible for ART who initiate treatment within 3 months of diagnosis
Time frame: 3 months
Population: Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) | 55 Participants |
| Short Message Service (SMS) Text Message | Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) | 79 Participants |
| SMS Text Message + Peer Navigation | Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) | 94 Participants |
p-value: 0.63696% CI: [0.48, 1.57]Regression, Logistic
p-value: 0.16595% CI: [0.87, 2.26]Regression, Logistic