The geography of emergency department-based HIV testing in South Africa: Can patients link to care?

BACKGROUND: Emergency Departments (EDs) can serve as clinical sites for identification of new HIV infections and their entry into care. We examined if HIV-positive patients who present to EDs in South Africa are able to successfully link to care. METHODS: We conducted a one-year longitudinal prospective cohort study in four hospitals across the Eastern Cape, South Africa, with participants followed between July 2016 and July 2018. All adult, non-critical patients presenting to the ED were systematically approached, asked about their HIV status, and, if unknown, offered a point-of-care (POC) HIV test. All HIV-positive patients were further consented to participate in a follow-up study to assess subsequent linkage to care and distance from "home" to ED. Linkage to care was defined as self-reported linkage (telephonic) or evidence of repeated CD4/viral load testing in the National Health Laboratory System (NHLS) at either the 6- or 12-months post index ED visit. FINDINGS: A total of 983 HIV-positive patients consented to participate in the study. In the 12 months following their ED visit, 34·1% of patients demonstrated linkage to care (335/983), 23·8% did not link to care (234/983), and 42·1% (414/983) were lost to follow-up. Though not statistically significant, a high percentage of young men (27/50, 54%) and those presenting with a trauma-related complaints (100/205, 48.8%) did not link to care. A considerable proportion of patients (105/454, 23·2%,) resided 50 or more kilometers from their index ED sites, though there was not a significant difference in linkage to care rate between those who lived closer or further from the ED. INTERPRETATION: We have shown that strategies to improve linkage to care from the ED should consider the high rates of poor linkage among young men and those presenting to the ED with trauma. Furthermore, innovative linkage to care solutions will need to account for the unique geographical consideration of this population, given that many ED patients will need to continue care at a site distant from the diagnosis site. FUNDING: This research was supported by the South African Medical Research Council, the Division of Intramural Research, the National Institute of Allergy and Infectious Diseases, National Institutes of Health, and the Johns Hopkins Center for Global Health.

Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults.

BACKGROUND: A safe, effective vaccine is essential to eradicating human immunodeficiency virus (HIV) infection. A canarypox-protein HIV vaccine regimen (ALVAC-HIV plus AIDSVAX B/E) showed modest efficacy in reducing infection in Thailand. An analogous regimen using HIV-1 subtype C virus showed potent humoral and cellular responses in a phase 1-2a trial in South Africa. Efficacy data and additional safety data were needed for this regimen in a larger population in South Africa. METHODS: In this phase 2b-3 trial, we randomly assigned 5404 adults without HIV-1 infection to receive the vaccine (2704 participants) or placebo (2700 participants). The vaccine regimen consisted of injections of ALVAC-HIV at months 0 and 1, followed by four booster injections of ALVAC-HIV plus bivalent subtype C gp120-MF59 adjuvant at months 3, 6, 12, and 18. The primary efficacy outcome was the occurrence of HIV-1 infection from randomization to 24 months. RESULTS: In January 2020, prespecified criteria for nonefficacy were met at an interim analysis; further vaccinations were subsequently halted. The median age of the trial participants was 24 years; 70% of the participants were women. The incidence of adverse events was similar in the vaccine and placebo groups. During the 24-month follow-up, HIV-1 infection was diagnosed in 138 participants in the vaccine group and in 133 in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.81 to 1.30; P = 0.84). CONCLUSIONS: The ALVAC-gp120 regimen did not prevent HIV-1 infection among participants in South Africa despite previous evidence of immunogenicity. (HVTN 702 ClinicalTrials.gov number, NCT02968849.).

Patient acceptance of HIV testing services in rural emergency departments in South Africa.

BACKGROUND: South Africa faces the highest burden of HIV infection globally. The National Strategic Plan on HIV recommends provider-initiated HIV counselling and testing (HCT) in all healthcare facilities. However, HIV continues to overwhelm the healthcare system. Emergency department (ED)-based HCT could address unmet testing needs. OBJECTIVES: This study examines the reasons for accepting or declining HCT in South African EDs to inform the development of HCT implementation strategies. METHOD: We conducted a prospective observational study in two rural EDs, from June to September 2017. Patients presenting to the ED were systematically approached and offered a point-of-care test in accordance with national guidelines. Patients demographics, presenting compaint, medical history and reasons for accepting/declining testing, were recorded. A pooled analysis is presented. RESULTS: Across sites, 2074 adult, non-critical patients in the ED were approached; 1880 were enrolled in the study. Of those enrolled, 19.7% had a previously known positive diagnosis, and 80.3% were unaware of their HIV status. Of those unaware, 90% patients accepted and 10% declined testing. The primary reasons for declining testing were 'does not want to know status' (37.6%), 'in too much pain' (34%) and 'does not believe they are at risk' (19.9%). CONCLUSIONS: Despite national guidelines, a high proportion of individuals remain undiagnosed, of which a majority are young men. Our study demonstrated high patient acceptance of ED-based HCT. There is a need for investment and innovation regarding effective pain management and confidential service delivery to address patient barriers. Findings support a routine, non-targeted HCT strategy in EDs.

Targeting the HIV Epidemic in South Africa: The Need for Testing and Linkage to Care in Emergency Departments.

BACKGROUND: The Eastern Cape province of South Africa has one of the highest burdens of HIV in the world. Emergency Departments (EDs) can serve as optimal clinical sites for the identification of new HIV infections and entry into care. We sought to determine the current burden of HIV disease among ED patients in the Eastern Cape. METHODS: We conducted a prospective cross-sectional observational study in the EDs of three Hospitals in the Eastern Cape province of South Africa from June 2017 to July 2018. All adult, non-critical patients presenting to the ED were systematically approached and offered a Point-Of-Care (POC) HIV test in accordance with South African guidelines. All HIV-positive individuals had their blood tested for the presence of antiretroviral therapy (ART) and the presence of viral suppression (≤ 1000 copies/ml). HIV incidence was estimated using a multi-assay algorithm, validated for a subtype C epidemic. FINDINGS: Of the 2901 patients for whom HIV status was determined (either known HIV-positive or underwent POC HIV testing), 811 (28.0%) were HIV positive, of which 234 (28.9%) were newly diagnosed. HIV prevalence was higher in Mthatha [34% (388/1134) at Mthatha Regional Hospital and 28% (142/512) at Nelson Mandela Academic Hospital], compared to Port Elizabeth [22% (281/1255) at Livingstone Hospital]. HIV incidence was estimated at 4.5/100 person-years (95% CI: 2.4, 6.50) for women and 1.5 (CI 0.5, 2.5) for men. Of all HIV positive individuals tested for ART (585), 54% (316/585) tested positive for the presence of ARTs, and for all HIV positive participants with viral load data (609), 49% (299/609) were found to be virally suppressed. INTERPRETATION: Our study not only observed a high prevalence and incidence of HIV among ED patients but also highlights significant attrition along the HIV care cascade for HIV positive individuals. Furthermore, despite developing an optimal testing environment, we were only able to enrol a small sub-set of the ED population. Given the high HIV prevalence and high attrition in the ED population, HIV services in the ED should also develop strategies that can accommodate large testing volumes and ART initiation.

Implementing emergency department-based HIV testing in a low-resource setting: The value of a structured feasibility assessment tool.

INTRODUCTION: HIV is a worldwide health problem with continuing high rates of new infections in many parts of the world. This lack of progress in decreasing overall incidence rates has sparked innovative HIV testing strategies, including expansion of testing into the emergency department (ED) setting. Emergency departments have been shown to be high-yield testing venues in the United States and other developed world settings. The feasibility of expanding public health HIV services in the ED in limited-resource countries is unclear. METHODS: We performed a cross-sectional feasibility assessment of a convenience sample of four hospitals in the Eastern Cape, South Africa. We administered three adapted interview tools from a previously field-tested survey instrument at each facility (total of 10 interviews) to gather an overview of the health facility, their HIV counselling and testing services, and their laboratory services. RESULTS: All of the health facilities had access to basic commodities such as water and electricity. Many had severe human resource limitations and provided care to wide population catchment areas. In addition, there was little integration of HIV testing into current daily ED operations. Hospital staff identified numerous barriers to future ED testing efforts. CONCLUSIONS: Although control of the HIV epidemic requires innovative testing strategies and treatment, specific assessments are warranted on how to incorporate routine HIV testing into an acute care facility like the ED, which typically has many competing priorities. The use of a prospective structured tool incorporating both barriers and benefits can provide valuable field-tested guidance for increased programme planning for HIV testing.