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NCT Number: NCT06408142

Universal Test and Connect for HIV Service Delivery in South Africa

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIV testing

Diagnostic Test

Point of Care HIV testing universally regardless of risk factors

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

Primary outcomes

  1. The proportion of potentially PrEP eligible patients in the ED

    Time frame: Baseline

    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

Secondary outcomes

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

    Time frame: Baseline

    Lab testing obtained through medical record

  2. The number of potentially PrEP eligible patients with renal dysfunction

    Time frame: Baseline

    Lab testing obtained through medical record

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

    Time frame: Baseline

    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

  4. Acceptability of ED PrEP to ED Providers

    Time frame: after implementation of UTC

Study contacts

Contact information is provided by the study sponsor or research team.

David Rudolph, MD

CONTACT

[email protected]

3195419183

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Desmond Tutu HIV Foundation
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: UTC: SA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 9, 2024
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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