Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408142
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-06
Brief Title:
Universal Test and Connect for HIV Service Delivery in South Africa
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Universal Test and Connect for HIV Service Delivery in South Africa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
UTC-SA
Brief Summary:
The goal of this study is to determine how many patients with HIV or at high risk of getting HIV attend the Emergency Department ED in South Africa SA the investigators will integrate HIV assessment in the ED and see how many people who would be a candidate for a drug that prevents HIV PrEP Universal test and connect UTC is a strategy that universally tests all patients and connects patients to long-term care whether HIV positive or negative including referrals for PrEP The investigators goal is to use UTC across two busy 24-hr EDs in Cape Town SA
Detailed Description:
The overarching goal of this proposal is to deliver comprehensive HIV services for patients with HIV or at high risk of HIV acquisition attending the Emergency Department ED in South Africa SA The investigators seek to integrate HIV assessment in the ED and define the opportunity for delivering biomedical HIV prevention interventions in this setting In SA a high proportion of people living with HIV PLHIV receive care in the ED 25 of ED patients are living with HIV and of these only 45 are on ART compared to 75 nationally 7 of ED patients with HIV have not previously been diagnosed The EDs provide care to high volumes of adults who may not otherwise interact with the health system and thus are an important testing and linkage to care venue Access to both preventative pre- and post-exposure prophylaxis and therapeutic ART antiretroviral initiation HIV services from the ED can expand care to otherwise missed populations and aligns directly with a differentiated service delivery model that is integrated within existing sustainable service delivery models
Universal test and connect UTC is a holistic strategy that endeavors to accelerate the race to reduce new HIV infections and deaths from AIDS-related illnesses Trials in Africa have shown that within three years of implementing a community-wide UTC program HIV incidence decreased by 20-30 and AIDS-related mortality decreased by 20 This strategy resulted in increased diagnosis among men and provided preventative resources to young women Given ED patients vulnerabilities and lack of access to routine services UTC is a new and needed tool to provide comprehensive ED-based HIV services Currently testing is haphazard and while occupational exposure may be addressed preventative strategies for other high-risk exposures are not
The investigators seek to demonstrate that the ED has a high volume of patients that could potentially benefit from HIV services ie HIV testing ART initiation pre-exposure prophylaxis PrEPpost-exposure prophylaxis PEP initiation and linkage to care and that HIV service delivery in this venue is necessary and feasible to integrate Furthermore the investigators seek to explore the missed opportunity to deliver PrEP in the ED thus expanding PrEP access to all segments of the population The investigators propose to demonstrate that PrEP initiation in the ED is an important investment to providing holistic care for ED patients and that providers will be accepting of ED-based PrEP delivery if HIV testing and PrEP initiation can be effectively integrated into clinical workflow
Universal test and connect UTC is a holistic strategy that endeavors to accelerate the race to reduce new HIV infections and deaths from AIDS-related illnesses Trials in Africa have shown that within three years of implementing a community-wide UTC program HIV incidence decreased by 20-30 and AIDS-related mortality decreased by 20 This strategy resulted in increased diagnosis among men and provided preventative resources to young women Given ED patients vulnerabilities and lack of access to routine services UTC is a new and needed tool to provide comprehensive ED-based HIV services Currently testing is haphazard and while occupational exposure may be addressed preventative strategies for other high-risk exposures are not
The investigators seek to demonstrate that the ED has a high volume of patients that could potentially benefit from HIV services ie HIV testing ART initiation pre-exposure prophylaxis PrEPpost-exposure prophylaxis PEP initiation and linkage to care and that HIV service delivery in this venue is necessary and feasible to integrate Furthermore the investigators seek to explore the missed opportunity to deliver PrEP in the ED thus expanding PrEP access to all segments of the population The investigators propose to demonstrate that PrEP initiation in the ED is an important investment to providing holistic care for ED patients and that providers will be accepting of ED-based PrEP delivery if HIV testing and PrEP initiation can be effectively integrated into clinical workflow
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None