Universal Test and Connect for HIV Service Delivery in South Africa

NCT ID: NCT06408142

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-19
• Study Completion Date: 2027-12-01

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

HIV testing

Intervention Type: DIAGNOSTIC_TEST

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

In-depth interview

Intervention Type: OTHER

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

Interventions

HIV testing

Point of Care HIV testing universally regardless of risk factors

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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:

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Desmond Tutu HIV Foundation

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bhakti Hansoti, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Gugulethu Community Health Centre

Cape Town, Western Cape, South Africa

Site Status: RECRUITING

Countries

South Africa

Central Contacts

David Rudolph, MD

Role: CONTACT

drudolp3@jhmi.edu

3195419183

Facility Contacts

Yashna Singh

Role: primary

info@hiv-research.org.za

+27 (0) 21 301 2020

Other Identifiers

1R34MH138250

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00443103

Identifier Type: -

Identifier Source: org_study_id