Universal Test and Connect for HIV Service Delivery in South Africa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HIV testing, In-depth interview.
- Who it may be relevant to
- Registry conditions: Human Immunodeficiency Virus, Pre-Exposure Prophylaxis, Emergency Department, South Africa. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Africa
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Universal Test and Connect for HIV Service Delivery in South Africa and Baltimore
Overview
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.
Interventions
- Diagnostic test HIV testing
Point of Care HIV testing universally regardless of risk factors - Other 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
Primary outcome measures
- The proportion of potentially PrEP eligible patients in the ED [Time frame: Baseline]
Secondary outcome measures (4)
- The number of potentially PrEP eligible patients with tuberculosis or acute HIV [Time frame: Baseline]
- The number of potentially PrEP eligible patients with renal dysfunction [Time frame: Baseline]
- The number of potentially PrEP eligible patients who report baseline difficulty to engage in follow up required to be on PrEP [Time frame: Baseline]
- Acceptability of ED PrEP to ED Providers [Time frame: after implementation of UTC]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
South Africa · 1 center
- Gugulethu Community Health Centre — Cape Town
Identifiers
NCT: NCT06408142 · IRB00443103 · 1R34MH138250