Universal Test and Connect for HIV Service Delivery in South Africa

Human Immunodeficiency Virus Clinical Trial

— UTC-SA  

Official title:

Universal Test and Connect for HIV Service Delivery in South Africa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408142
• Other study ID #: IRB00443103
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: David Rudolph, MD
• Phone: 3195419183
• Email: drudolp3[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 investigator's goal is to use UTC across two busy 24-hr EDs in Cape Town, SA.

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 (i.e., HIV testing, ART initiation, pre-exposure prophylaxis (PrEP)/post-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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1573
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Patients attending the Emergency Department

• Ages > or = 12 years old

Exclusion Criteria:

• Patients unable to provide written informed consent - i.e., have a depressed level of consciousness (head trauma or concurrent alcohol/substance abuse), determined as critically ill (triage score of "emergent"), or

• do not speak a language spoken by the study team (English, Afrikaans, and Xhosa).

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Emergencies
• Emergency Department
• HIV Infections
• Human Immunodeficiency Virus
• Pre-Exposure Prophylaxis

Intervention

Diagnostic Test:
• HIV testing
Point of Care HIV testing universally regardless of risk factors

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Desmond Tutu HIV Foundation, National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of potentially PrEP eligible patients in the ED	Baseline survey, chart abstraction, and use of South Africa National Department of Health PrEP Eligibility Guidelines	Baseline
Secondary	The number of potentially PrEP eligible patients with tuberculosis or acute HIV	Lab testing obtained through medical record	Baseline
Secondary	The number of potentially PrEP eligible patients with renal dysfunction	Lab testing obtained through medical record	Baseline
Secondary	The number of potentially PrEP eligible patients who report baseline difficulty to engage in follow up required to be on PrEP	Social Determinants of Health Survey including financial insecurity (1-5), food insecurity (two questions, one 1-4 and the other 1-5), transportation needs (yes vs no as need for transportation within past 12 months), physical activity level (days per week of exercise and average exercise time per exercise session), stress (1-5), social connections (1-5), substance use (number of drinks or use off illicit substances used per week), intimate partner violence (Number of instances in past 12 months). Scored on subscales, parentheses indicating Likert scores with lower scores indicating worse outcome	Baseline