Universal Test and Connect for HIV Service Delivery in South Africa (UTC: SA)

Universal Test and Connect for HIV Service Delivery in South Africa and Baltimore

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.

Study Overview

• Status: Recruiting
• Conditions: Human Immunodeficiency Virus; Emergency Department; Pre-Exposure Prophylaxis; South Africa
• Intervention / Treatment: Diagnostic test: HIV testing; Other: In-depth interview

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. 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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: David Rudolph, MD; Phone Number: 3195419183; Email: drudolp3@jhmi.edu

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa
      • Recruiting
      • Gugulethu Community Health Centre
      • Contact: Yashna Singh; Phone Number: +27 (0) 21 301 2020; Email: info@hiv-research.org.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Cross-sectional population attending the Emergency Departments, which are both publicly available 24-hour Emergency Departments that serve the surrounding neighborhood/catchment area.

Description

Inclusion Criteria for universal testing and connecting:

• Patients attending the Emergency Department
• Ages > or = 12 years old in South Africa
• For subset that participate in PrEP choice trial, inclusion criteria will be to ensure that they meet PrEP eligibility criteria and do not have any contraindications to PrEP (kidney disease, acute HIV signs or symptoms, already taking PrEP).

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).

In-depth interviews and surveys to providers:

Inclusion Criteria:

• Nurses, physicians, or advanced practice providers (APPs) who work regularly in the Emergency Department at one of the clinical sites.
• Consent to a recorded in-depth interview and/or Normalizing Process Theory (NPT) survey

Exclusion Criteria:

• Providers who have already been interviewed (if working at both clinical sites)
• Providers who do not consent to an interview or a survey.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Emergency Department Patients in South Africa; Universal Test and Connect: universal screening with HIV testing followed by demographic/clinical information to determine number of patients who would be eligible for HIV PrEP	Diagnostic test: HIV testing; Point of Care HIV testing universally regardless of risk factors
Emergency Department Providers; Nurses, physicians, or advanced practice providers who deliver care in the Emergency Department at one of the clinical sites	Other: In-depth interview; In-depth interviews of providers using Normalization Process Theory semi-structured interview guide to assess provider perspectives of PrEP delivery in the ED

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of potentially PrEP eligible patients in the ED	Baseline survey, chart abstraction, and use of South Africa National Department of Health and Centers for Disease Control and Prevention (CDC) pre-exposure prophylaxis (PrEP) Eligibility Guidelines	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of potentially PrEP eligible patients with tuberculosis or acute HIV	Lab testing obtained through medical record	Baseline
The number of potentially PrEP eligible patients with renal dysfunction	Lab testing obtained through medical record	Baseline
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
Acceptability of ED PrEP to ED Providers		after implementation of UTC

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Mental Health (NIMH); Desmond Tutu HIV Foundation
• Investigators: Principal Investigator: Bhakti Hansoti, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Pathological Conditions, Signs and Symptoms; Emergencies; Acquired Immunodeficiency Syndrome; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Microbiological Techniques; HIV Testing
• Other Study ID Numbers: IRB00443103; 1R34MH138250 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available to other researchers that are explicitly on the IRB (Institutional Review Board) both at Johns Hopkins or on local IRBs at University of Cape Town and Stellenbosch University. All information will be de-identified while not on an encrypted password-protected database to ensure participant confidentiality
• IPD Sharing Time Frame: Throughout duration of study period (anticipated 2027) and up to 5 years after.
• IPD Sharing Access Criteria: Researchers/analysts on the Institutional Review Board (IRB) submission at each of the IRB sites for this multi-center study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No