- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417233
Engagement to Care South Africa (ICARE)
November 17, 2017 updated by: University of California, San Francisco
Improving Engagement to HIV Prevention and Care in North West, South Africa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
756
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Northwest
-
Mabeskraal, Northwest, South Africa
- Moses Kotane Sub-district clinics
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Rustenburg, Northwest, South Africa
- Rustenburg Sub-district clinics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
bi-weekly behavioral messages plus personalized peer navigation
|
What is the study measuring?
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)
Time Frame: 3 months
|
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)
Time Frame: 3 months
|
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)
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.
|
12 months
|
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
|
12 months
|
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)
|
12 months
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
- Steward WT, Agnew E, de Kadt J, Ratlhagana MJ, Sumitani J, Gilmore HJ, Grignon J, Shade SB, Tumbo J, Barnhart S, Lippman SA. Impact of SMS and peer navigation on retention in HIV care among adults in South Africa: results of a three-arm cluster randomized controlled trial. J Int AIDS Soc. 2021 Aug;24(8):e25774. doi: 10.1002/jia2.25774.
- Lippman SA, Shade SB, Sumitani J, DeKadt J, Gilvydis JM, Ratlhagana MJ, Grignon J, Tumbo J, Gilmore H, Agnew E, Saberi P, Barnhart S, Steward WT. Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial. Trials. 2016 Feb 6;17:68. doi: 10.1186/s13063-016-1190-y.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
December 12, 2014
First Submitted That Met QC Criteria
April 14, 2015
First Posted (Estimate)
April 15, 2015
Study Record Updates
Last Update Posted (Actual)
August 20, 2018
Last Update Submitted That Met QC Criteria
November 17, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12-10482
- P0054377 (Other Grant/Funding Number: PHS Health Resources & Services Admin.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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