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Engagement to Care South Africa (ICARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02417233
Recruitment Status : Completed
First Posted : April 15, 2015
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: SMS text message Behavioral: SMS text message + Peer Navigation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Engagement to HIV Prevention and Care in North West, South Africa
Study Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
No Intervention: 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.
Active Comparator: 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.
 Behavioral: SMS text message
bi-weekly behavioral messages and bi-weekly check-in messages
Active Comparator: 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.
 Behavioral: SMS text message + Peer Navigation
bi-weekly behavioral messages plus personalized peer navigation


Outcome Measures
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Primary Outcome Measures :
  1. Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary) [ Time Frame: 3 months ]
    Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)

  2. Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis) [ Time Frame: 3 months ]
    Participants eligible for ART who initiate treatment within 3 months of diagnosis

  3. Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment) [ Time Frame: 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.

  4. Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis) [ Time Frame: 12 months ]
    Participants who return for repeat CD4 testing within 12 months of diagnosis

  5. Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL) [ Time Frame: 12 months ]
    Viral load test results <400 copies/mL (consistent with current and correct adherence to ART)

  6. Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417233


Locations
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South Africa
Moses Kotane Sub-district clinics
Mabeskraal, Northwest, South Africa
Rustenburg Sub-district clinics
Rustenburg, Northwest, South Africa
Sponsors and Collaborators
University of California, San Francisco
University of Washington
Investigators
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Principal Investigator: Sheri Lippman, PhD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02417233    
Other Study ID Numbers: 12-10482
P0054377 ( Other Grant/Funding Number: PHS Health Resources & Services Admin. )
First Posted: April 15, 2015    Key Record Dates
Results First Posted: August 20, 2018
Last Update Posted: August 20, 2018
Last Verified: November 2017
Keywords provided by University of California, San Francisco:
HIV-positive
adherence
engagement to care
mobile Health (mHealth)
 SMS
peer navigation
retention