Universal Test and Connect for HIV Service Delivery in South Africa
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
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
Trial population
Cross-sectional population attending the Emergency Departments, which are both publicly available 24-hour Emergency Departments that serve the surrounding neighborhood/catchment area.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
HIV testing
Diagnostic testPoint of Care HIV testing universally regardless of risk factors
In-depth interview
Other interventionIn-depth interviews of providers using Normalization Process Theory semi-structured interview guide to assess provider perspectives of PrEP delivery in the ED
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Emergency Department Patients in South Africa1 intervention
Group B: Emergency Department Providers1 intervention
Trial outcomes
Primary outcomes
1
The proportion of potentially PrEP eligible patients in the ED
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
Time frame
BaselineSecondary outcomes
1
The number of potentially PrEP eligible patients with tuberculosis or acute HIV
Lab testing obtained through medical record
Time frame
Baseline2
The number of potentially PrEP eligible patients with renal dysfunction
Lab testing obtained through medical record
Time frame
Baseline3
The number of potentially PrEP eligible patients who report baseline difficulty to engage in follow up required to be on PrEP
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
Time frame
Baseline4
Acceptability of ED PrEP to ED Providers
Time frame
after implementation of UTCSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Desmond Tutu HIV Foundation
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov