Engagement to Care South Africa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Engagement to HIV Prevention and Care in North West, South Africa

Conditions
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HIV

Intervention / Treatment
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* Behavioral: SMS text message
* Behavioral: SMS text message + Peer Navigation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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. | |
| Active Comparator: SMS text message<br>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. | Behavioral: SMS text message<br>* bi-weekly behavioral messages and bi-weekly check-in messages<br>|
| Active Comparator: SMS text message + Peer Navigation<br>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. | Behavioral: SMS text message + Peer Navigation<br>* bi-weekly behavioral messages plus personalized peer navigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 months | 
| 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 | 3 months | 
| 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. | 12 months | 
| 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 | 12 months | 
| 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) | 12 months | 
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-positive, adherence, engagement to care, mobile Health (mHealth), SMS, peer navigation, retention