Engagement to Care South Africa
ICARE
Improving Engagement to HIV Prevention and Care in North West, South Africa
2 other identifiers
interventional
756
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv
Started Oct 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 12, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
August 20, 2018
CompletedAugust 20, 2018
November 1, 2017
1.7 years
December 12, 2014
June 27, 2017
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (3)
Standard of Care
NO INTERVENTIONParticipants 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 COMPARATORParticipants 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 + Peer Navigation
ACTIVE COMPARATORParticipants 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.
Interventions
bi-weekly behavioral messages and bi-weekly check-in messages
bi-weekly behavioral messages plus personalized peer navigation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- University of Washingtoncollaborator
Study Sites (2)
Moses Kotane Sub-district clinics
Mabeskraal, Northwest, South Africa
Rustenburg Sub-district clinics
Rustenburg, Northwest, South Africa
Related Publications (5)
Leslie HH, Mooney AC, Gilmore HJ, Agnew E, Grignon JS, deKadt J, Shade SB, Ratlhagana MJ, Sumitani J, Barnhart S, Steward WT, Lippman SA. Prevalence, motivation, and outcomes of clinic transfer in a clinical cohort of people living with HIV in North West Province, South Africa. BMC Health Serv Res. 2022 Dec 26;22(1):1584. doi: 10.1186/s12913-022-08962-8.
PMID: 36572869DERIVEDLippman SA, de Kadt J, Ratlhagana MJ, Agnew E, Gilmore H, Sumitani J, Grignon J, Gutin SA, Shade SB, Gilvydis JM, Tumbo J, Barnhart S, Steward WT. Impact of short message service and peer navigation on linkage to care and antiretroviral therapy initiation in South Africa. AIDS. 2023 Mar 15;37(4):647-657. doi: 10.1097/QAD.0000000000003453. Epub 2022 Dec 5.
PMID: 36468499DERIVEDSteward 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.
PMID: 34435440DERIVEDPalmer 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.
PMID: 32779730DERIVEDLippman 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.
PMID: 26852237DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sheri Lippman
- Organization
- University of California San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Sheri Lippman, PhD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2014
First Posted
April 15, 2015
Study Start
October 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 20, 2018
Results First Posted
August 20, 2018
Record last verified: 2017-11