Universal Test and Connect for HIV services in Cape Town emergency departments

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

This project tests whether offering universal HIV testing and connection-to-care in two Cape Town emergency departments can find people with HIV or at high risk and link them to treatment or PrEP.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Locations: 1 site (Cape Town, Western Cape)
• Trial ID: NCT06408142 on ClinicalTrials.gov

What this trial studies

This observational project integrates universal HIV testing and linkage-to-care into two busy 24-hour emergency departments in Cape Town, South Africa. All patients aged 12 and older who attend the EDs will be offered HIV testing, with positive cases linked to antiretroviral therapy and eligible HIV-negative patients referred for pre-exposure prophylaxis (PrEP). Investigators will document how many patients are HIV-positive or meet PrEP eligibility and will conduct provider interviews to understand implementation barriers and workflows. The approach aims to use existing ED workflows to expand diagnosis, prevention, and linkage within a sustainable service-delivery model.

Who should consider this trial

Good fit: Ideal participants are ED patients aged 12 or older who can give written consent, speak English, Afrikaans, or Xhosa, and are either living with HIV or at risk for HIV acquisition.

Not a fit: Patients who are critically ill, unable to give consent, do not speak the study languages, are already on PrEP, have contraindications to PrEP, or are outside the participating EDs are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the program could find more people with HIV or at high risk and get them started on treatment or PrEP, potentially reducing new infections and AIDS-related deaths.

How similar studies have performed: Community-wide UTC programs in Africa have previously reduced HIV incidence by 20–30% and AIDS-related mortality by about 20%, though using UTC specifically in ED settings is less well studied.

Eligibility criteria

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.

Where this trial is running

Cape Town, Western Cape

• Gugulethu Community Health Centre — Cape Town, Western Cape, South Africa (Recruiting)

Study contacts

• Principal investigator: Bhakti Hansoti, MD — Johns Hopkins University
• Study coordinator: David Rudolph, MD

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