Universal Test and Connect for HIV Service Delivery in South Africa and Baltimore
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The proportion of potentially PrEP eligible patients in the ED
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Emergency Department Patients in South Africa
Universal Test and Connect: universal screening with HIV testing followed by demographic/clinical information to determine number of patients who would be eligible for HIV PrEP
干预措施: HIV testing (Diagnostic Test)
Emergency Department Providers
Nurses, physicians, or advanced practice providers who deliver care in the Emergency Department at one of the clinical sites
干预措施: In-depth interview (Other)
结局指标
主要结局
The proportion of potentially PrEP eligible patients in the ED
时间窗: 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
次要结局
- The number of potentially PrEP eligible patients with tuberculosis or acute HIV(Baseline)
- The number of potentially PrEP eligible patients with renal dysfunction(Baseline)
- The number of potentially PrEP eligible patients who report baseline difficulty to engage in follow up required to be on PrEP(Baseline)
- Acceptability of ED PrEP to ED Providers(after implementation of UTC)