Clinical trial Recruiting at 1 site Observational Ages 12 and up

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

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

Run by Johns Hopkins University · NCT06408142 · Data updated 2026-11-12

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.

More Human Immunodeficiency Virus trials

Quick facts

Study typeObservational
Ages12 Years and up
SexAll
Enrollment2000 (estimated)
SponsorJohns Hopkins University
Academic / other
Locations1 site (Cape Town, Western Cape)
StatusRecruiting
StartedJanuary 19, 2026
Main results expectedDecember 1, 2027
Study endsDecember 1, 2027
Registry record updatedJanuary 30, 2026
Trial IDNCT06408142 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: drudolp3@jhmi.edu
  • Phone: 3195419183

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.