Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02417233
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Engagement to Care South Africa
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Improving Engagement to HIV Prevention and Care in North West, South Africa
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICARE
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P0054377 | OTHER_GRANT | PHS Health Resources & Services Admin. | View |