Engagement to Care South Africa (ICARE)

University of California San Francisco (UCSF)

Status: Completed

Conditions: HIV

Treatments: Behavioral: SMS text message; Behavioral: SMS text message + Peer Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02417233

P0054377 (Other Grant/Funding Number)

12-10482

Details and patient eligibility

About

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.

Full 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.

Enrollment: 756 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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756 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

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.

SMS text message

Active Comparator group

Description:

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.

Treatment:

Behavioral: SMS text message

SMS text message + Peer Navigation

Active Comparator group

Description:

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.

Treatment:

Behavioral: SMS text message + Peer Navigation