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
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: SMS text message Behavioral: SMS text message + Peer Navigation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||756 participants|
|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|
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
- 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)
- 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
- 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.
- 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
- 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)
- 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.
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
|Moses Kotane Sub-district clinics|
|Mabeskraal, Northwest, South Africa|
|Rustenburg Sub-district clinics|
|Rustenburg, Northwest, South Africa|
|Principal Investigator:||Sheri Lippman, PhD||University of California, San Francisco|