Universal Test and Connect for HIV Service Delivery in South Africa

NCT06408142 | Recruiting DMC

• 2 other identifiers: IRB004431031R34MH138250
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

Human Immunodeficiency Virus; Pre-Exposure Prophylaxis; Emergency Department; South Africa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The number of potentially PrEP eligible patients with tuberculosis or acute HIV

  Baseline

• The number of potentially PrEP eligible patients with renal dysfunction

  Baseline

• The number of potentially PrEP eligible patients who report baseline difficulty to engage in follow up required to be on PrEP

  Baseline

• Acceptability of ED PrEP to ED Providers

  after implementation of UTC

Study Arms (2)

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

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

Interventions

HIV testing DIAGNOSTIC_TEST

Point of Care HIV testing universally regardless of risk factors

Emergency Department Patients in South Africa

In-depth interview OTHER

In-depth interviews of providers using Normalization Process Theory semi-structured interview guide to assess provider perspectives of PrEP delivery in the ED

Emergency Department Providers

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients attending the Emergency Department
• Ages \> or = 12 years old in South Africa

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Desmond Tutu HIV Foundation: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Gugulethu Community Health Centre

Cape Town, Western Cape, South Africa

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Emergencies

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bhakti Hansoti, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Rudolph, MD

CONTACT

3195419183; drudolp3@jhmi.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: January 19, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Throughout duration of study period (anticipated 2027) and up to 5 years after.
• Access Criteria: Researchers/analysts on the Institutional Review Board (IRB) submission at each of the IRB sites for this multi-center study

Locations

ZA (1)