Clinical trial NCT06747221: Implementation Science to Enhance HIV Testing Services During Emergency Care in Kenya
Official title: HIV Enhanced Access Testing in Emergency Department Program Using a Systems Analysis and Improvement Approach (HEATED-SAIA) Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV
Keywords: HIV
SAIA
Emergency Care
Africa
Kenya
Emergency Services
HIV Testing Services
Systems Analysis and Improvement Approach
Implementation Science
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Brown University
First posted: 2024-12-24
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster parallel trial with a baseline measurement period.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There are \~38 million people living with HIV (PLH), with the majority in low-and middle-income countries (LMICs), where the UNAIDS 95-95-95 HIV targets are at risk of not being achieved. Data show that incident infections are concentrated in sub-Saharan Africa and focused in difficult to reach populations. These underserved persons frequently also have higher-risk profiles for HIV, making them essential target populations to receive HIV Testing Services (HTS). Among underserved populations, men, adolescents and young adults (AYAs) aged 15-24 years, and persons from key populations (KPs) represent crucial groups to be reached. In Africa, Emergency Departments (ED) provide care to large numbers of persons that often do not otherwise access health services. Data from Africa show that those seeking emergency care have high burdens of HIV, and desire ED-HTS. As in higher-income countries, EDs in LMICs provide a strategic opportunity to deliver evidence-based HTS interventions to higher-risk and underserved persons. In Kenya one in five PLH are unaware of their status, less than half of men are reached for HIV testing at appropriate frequencies, AYAs account for 42% of new infections and KPs contribute to hyper-endemic transmission. To address this, Kenya's national strategy calls for utilizing facilities-based care to deliver HTS for difficult to reach populations. However, while the guidelines include EDs as service delivery points, HTS during emergency care in Kenya is still evolving and the evidence-base on best practices is in early development. The HIV Enhanced Access Testing in Emergency Department (HEATED) program in Kenya was developed by a collaborative team led by PI Aluisio (K23AI145411). The HEATED program was derived using the Capability-Opportunity-Motivation Behavioral model to enhance delivery of HTS, through locally appropriate and pragmatic systems initiatives. HEATED program implementation significantly improved HIV testing for the overall ED population by 31%, while also significantly increasing testing for men, AYA and KP and was found to be acceptable by stakeholders. Although pilot evaluation of the HEATED program demonstrated improved HTS for underserved populations, more robust understanding of optimal implementation strategies in ED settings, impacts on linkage to HIV care outcomes, costing and maintenance data are needed to inform development of ED-HTS programming in Kenya. To address this, the current study will build upon the HEATED program by evaluating use of the Systems Analysis and Improvement Approach (SAIA) implementation strategy (HEATED-SAIA) to improve HTS in a cluster randomized trial in all Ministry of Health EDs in Kilifi, Mombasa and Kwale Counties of the Coast Region of Kenya. The Reach, Effectiveness, Adoption, Implementation and Maintenance framework with quantitative and qualitative data will be used in trial assessment. Building on the pilot data and leveraging SAIA, the HEATED-SAIA program has substantial potential to equitably improve HTS delivery by strategically and pragmatically engaging underserved populations already interfacing with emergency health systems, while being acceptable and cost-effective.

Detailed description: Globally, there are \~38 million people living with HIV (PLH), with the majority in low-and middle-income countries (LMICs), where the UNAIDS 95-95-95 HIV targets are at risk of not being achieved. Data show that incident infections are concentrated in sub-Saharan Africa (SSA) and focused in difficult to reach populations for HIV services. These underserved persons also often have higher-risk profiles for HIV making them priority populations to receive HIV Testing Services (HTS). Among underserved populations, men, adolescents and young adults (AYAs) aged 15-24 years, and persons from key populations (KPs), are crucial groups which must be regularly reached for HTS to achieve global control targets.

In LMICs, emergency departments (ED) provide care to large numbers of persons that often do not otherwise access health services. Injuries among men, AYA and KPs are frequent reasons for ED care. Data from Africa show that persons seeking emergency care have high HIV burdens, and desire ED-HTS. Furthermore, as EDs are gender and status-neutral care settings, ED-HTS may have fewer stigmatization barriers than conventional service delivery points (SDPs) to support equitable testing provision. However, data from multiple SSA studies show that ED HIV testing is infrequent, with \<25% of patients engaged for HTS during emergency care. EDs in LMICs represent a waiting strategic and pragmatic opportunity to deliver evidence-based HTS to higher-risk underserved persons already frequently in contact with health facilities.

While Kenya has reduced its HIV prevalence to \~4.0%, incidence reduction targets have not been met, and in 2021 there was an 7.8% increase in new infections. In Kenya, one in five people with HIV disease are undiagnosed, less than half of men are reached for HIV testing at appropriate frequencies, AYAs account for 42% of new infections and KPs contribute to hyper-endemic transmission. Kenya's national guidelines call for utilizing facilities-based care to deliver HTS for difficult to reach populations where the HIV epidemic is concentrated. While the guidelines include EDs as SDPs, emergency care HTS is still evolving in Kenya and best practice evidence is in early development. The HIV Enhanced Access Testing in Emergency Departments (HEATED) program in Nairobi, Kenya was developed by a collaborative team led by Principal Investigator (PI) Dr. Aluisio (K23AI145411). The program was a gender and status neutral systems intervention, using the Capability-Opportunity-Motivation Behavioral model to enhance ED-HTS, through data-driven, setting-specific, feasible systems adaptations designed to address modifiable barriers (micro-strategies). The HEATED program significantly improved likelihood of ED-HTS for the overall population by 31%, and significantly increased testing for men, AYA and KP. In addition, stakeholders affirmed that the program was acceptable.

Although evaluation of the HEATED program demonstrated improved HTS more robust understanding of optimal implementation strategies, impacts on linkage to HIV care and costing data are needed to inform ED-HTS advancement in Kenya. To address this, the current proposal builds upon the HEATED program by utilizing and evaluating the Systems Analysis and Improvement Approach (SAIA) implementation strategy (HEATED-SAIA) to enhance HTS delivery in a cluster randomized trial of all public facilities with EDs in Kilifi, Mombasa and Kwale Counties of the Coast region of Kenya. SAIA is a multi-component implementation strategy that utilizes cascade analysis, process flow mapping and micro-strategy development and testing in plan-do-study-act cycles to improve care delivery.46 SAIA implementation has been shown to improve HTS integration in family planning (FP) clinics in Mombasa County by the study team previously. Application of SAIA to ED settings in the Coast region has substantial potential to impactfully and equitably improve delivery of evidence-based HTS for underserved higher-risk persons already in contact with care, while also expanding the evidence-base for SAIA via application in a novel clinical space. This will be studied through the following aims:

Aim 1: Evaluate impacts of the HEATED-SAIA program as compared to standard care (control) in a cluster randomized trial of all ten public ED facilities in three counties in the Coast region of Kenya, to improve HIV screening, testing, and linkage to treatment and prevention, among persons receiving emergency care with a focus on underserved populations of men, AYA and KPs.

Approach: This cluster parallel trial, with a baseline measurement period, will randomize all ten public EDs in Kilifi, Mombasa and Kwale Counties (1:1) to control (usual care) or intervention (SAIA implementation strategy) and use the Reach, Effectiveness, Adoption, Implementation and Maintenance (REAIM) framework in trial assessment. Quantitative systems level data and qualitative participant level data, based on the Consolidated Framework for Implementation Research and the Implementation Research Logic Model will be used to inform appropriate use of the results in the study setting and larger public health context of Kenya.

Aim 2: Assess the cost of ED-HTS and implementation of the HEATED-SAIA program using micro-costing and time-and-motion costing methods to inform public health programming and future scale-up

Eligibility criteria: Facility Level (Quantitative De-identified Systems Data)

Inclusion Criteria:

* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties
* Have an active emergency department
* Have HIV testing services either embedded in the emergency department or the facility.

Exclusion Criteria:

* Private health facilities
* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties without an active emergency department
* Kenya public health facilities in Kwale, Mombassa and Kilifi Counties without existing HIV testing services

Participant Level (Qualitative Data) Healthcare Personnel

Inclusion Criteria:

* Personnel working at the departments of health in Kwale, Mombassa and Kilifi Counties
* Personnel working at a Kenya public health facilities randomized to the control or intervention arm in Kwale, Mombassa and Kilifi Counties
* Age 18 years or greater
* Able and willing to provide informed consent

Exclusion Criteria:

* Personnel not working at a Kenya public health facilities randomized to the control or intervention arm in Kwale, Mombassa and Kilifi Counties
* Age less than 18 years
* Not able and willing to provide informed consent

Participant Level (Qualitative Data) ED-HTS Clients

Inclusion Criteria:

* Patients receiving emergency care and engaged for ED-HTS at a Kenya public health facilities randomized to the intervention arm of the trial in Kwale, Mombassa and Kilifi Counties
* Age 18 years or greater
* Able and willing to provide informed consent

Exclusion Criteria:

* Age less than 18 years
* Not able and willing to provide informed consent

Primary outcomes:
measure: Reach: Staff Engagement
timeFrame: Quarterly (3-42 months)
measure: Reach: Patient Participation
timeFrame: Quarterly (3-42 months)
measure: Effectiveness: HIV Testing Delivery
timeFrame: Quarterly (3-42 months)
measure: Effectiveness: Linkage to Care for People Living with HIV
timeFrame: Quarterly (3-42 months)
measure: Effectiveness: PrEP Screening & Referral
timeFrame: Quarterly (3-42 months)
measure: Adoption: Uptake Determinants
timeFrame: Months: 1, 3 & 15
measure: Adoption: Staff Intentions
timeFrame: Months: 1, 6, 9 & 15
measure: Implementation: Feasibility
timeFrame: Monthly (3-42 months)
measure: Implementation: Fidelity
timeFrame: Months: 3, 15, & 40
measure: Implementation: Facilitators & Barriers
timeFrame: Months: 3, 15, 24 & 40
measure: Maintenance: Sustainability
timeFrame: Months: 24, 30, 36 & 42
measure: Maintenance: Penetration
timeFrame: Months: 24 & 40
measure: Economic evaluation: ED-HTS and implementation of the HEATED-SAIA program
timeFrame: months 3, 15 & 21
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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