Implementation Science to Enhance HIV Testing Services During Emergency Care in Kenya

NCT06747221 | Not Yet Recruiting DMC

• 1 other identifier: 2232153
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

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 harder to reach persons frequently also have higher-risk profiles for HIV, making them essential target populations to receive HIV Testing Services (HTS). Among target 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 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 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 target 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 proposal 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 K23 pilot data and leveraging SAIA, the HEATED-SAIA program has substantial potential to improve HTS delivery by strategically and pragmatically engaging difficult to reach populations already interfacing with emergency health systems, while being acceptable and cost-effective.

Conditions

HIV

Keywords

HIV; SAIA; Emergency Care; Africa; Kenya; Emergency Services; HIV Testing Services; Systems Analysis and Improvement Approach; Implementation Science

Outcome Measures

Primary Outcomes (13)

• Reach: Staff Engagement

  1. Proportion of personnel taking part in SAIA cycles (intervention sites) 2. Representativeness of staff taking part in SAIA cycles planning (intervention sites)

  Quarterly (3-42 months)

• Reach: Patient Participation

  1. Proportion of ED patients accepting referral for HTS among those screened \& eligible (intervention versus control sites) 2. Proportion of ED patients accepting referral for HTS for target populations of men and AYA among those screened \& eligible (intervention versus control sites)

  Quarterly (3-42 months)

• Effectiveness: HIV Testing Delivery

  1. Proportion of ED patients completing testing among patients appropriate for testing (intervention versus control sites) 2. Proportion of ED patients completing testing among target populations men and AYA appropriate for testing (intervention versus control sites) 3. Proportion of ED persons from KPs completing testing (intervention versus control sites)

  Quarterly (3-42 months)

• Effectiveness: Linkage to Care for People Living with HIV

  1. Proportion of ED patients tested identified as PLH linked to HIV care (intervention versus control sites) 2. Proportion of ED patients tested identified as PLH linked to HIV care among target populations of men and AYA (intervention versus control sites) 3. Proportion of ED persons from KPs tested identified as PLH linked to HIV care (intervention versus control sites)

  Quarterly (3-42 months)

• Effectiveness: PrEP Screening & Referral

  1. Proportion of ED patients testing negative screened and referred for PrEP (intervention versus control sites) 2. Proportion of ED patients testing negative among target populations of men and AYA screened and referred for PrEP (intervention versus control sites) 3. Proportion of ED persons from KPs testing negative screened and referred for PrEP (intervention site versus controls)

  Quarterly (3-42 months)

• Adoption: Uptake Determinants

  IRLM-CFIR qualitative data to understand HEATED-SAIA determinants of uptake (Primary SAIA Facilitators, Primary SAIA Implementers, DOH Personnel)

  Months: 1, 3 & 15

• Adoption: Staff Intentions

  Organizational climate and professional behaviors for ED and HTS personnel on HEATED-SAIA program (intervention sites)

  Months: 1, 6, 9 & 15

• Implementation: Feasibility

  1. Proportion of micro-strategies/cycle delivered subsequent cycle (intervention sites) 2. Proportion of micro-strategies identified and adopted from all HEATED-SAIA cycles delivered in the facility for \>6 months (intervention sites) 3. Integrated IRLM-CFIR qualitative data \& coincidence analysis of micro-strategies (intervention sites)

  Monthly (3-42 months)

• Implementation: Fidelity

  Qualitative data using IRLM-CFIR to understand HEATED-SAIA cycle fidelity (Primary SAIA Implementers at intervention site) (intervention sites)

  Months: 3, 15, & 40

• Implementation: Facilitators & Barriers

  IRLM-CFIR qualitative data on facilitators and barriers of HEATED-SAIA cycle completion (Primary SAIA Facilitators, Primary SAIA Implementers, DOH Personnel, ED-HTS clients)

  Months: 3, 15, 24 & 40

• Maintenance: Sustainability

  1. Continuation of HEATED-SAIA cycles with \>3 per 6 months (intervention site) 2. IRLM-CFIR qualitative data to understand determinates of HEATED-SAIA continuation in the absences of research staff (Primary SAIA Facilitators, Primary SAIA Implementers, DOH Personnel, ED-HTS clients)

  Months: 24, 30, 36 & 42

• Maintenance: Penetration

  Quantitative and qualitative data (IRLM-CFIR) to understand integration of HEATED-SAIA into institutional policy and procedures and related determinates for integration (Primary SAIA Facilitators, Primary SAIA Implementers, DOH Personnel)

  Months: 24 & 40

• Economic evaluation: ED-HTS and implementation of the HEATED-SAIA program

  Micro-costing and time-and-motion costing for ED-HTS programing (baseline) and HEATED-SAIA programming

  months 3, 15 & 21

Study Arms (1)

Standard care

ACTIVE COMPARATOR

Facilities in the control arm will receive regular standard program oversight by county department of health personnel but no further interventions related to the SAIA implementation stratgey.

Other: Systems Analysis and Improvement Approach (SAIA)

Interventions

Systems Analysis and Improvement Approach (SAIA) OTHER

SAIA is a 5-step implementation strategy that is repeated every 4-6 weeks for continuous quality improvement. It will be implemented by Kenyan public health workforce and frontline clinical care personnel to systematically identify and address bottlenecks to develop and implement solutions to delivery of HIV Testing Services during emergency department (ED) interactions. Step 1: Understanding the cascade of ED patient flow from triage through care conclusion with focus on HTS opportunities. This will support identification of bottlenecks where patients are missed and provides data on potential increases in efficiency if misses are addressed. Step 2: Use process mapping to identify modifiable bottlenecks. Step 3: Define and implement workflow adaptations to mitigate modifiable bottlenecks. Step 4: Monitor changes in performance. Step 5: Repeat the analysis and improvement cycle (steps 1-4).

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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
• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead
• University of Washington: collaborator
• Brown University: collaborator

Central Study Contacts

Adam Aluisio, MD, MSc, DTM&H

CONTACT

1-401-444-9891; adam_aluisio@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cluster parallel trial with a baseline measurement period.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 27, 2026

Record last verified: 2025-12