HIVHEATED-SAIANCT06747221
Implementation Science to Enhance HIV Testing Services During Emergency Care in Kenya
A study testing Systems Analysis and Improvement Approach (SAIA) in people with HIV, run by Rhode Island Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Systems Analysis and Improvement Approach (SAIA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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
Show all 10Show fewer
- Able and willing to provide informed consent
- 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
Who cannot join
- 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 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
Show all 10Show fewer
- Not able and willing to provide informed consent
- Participant Level (Qualitative Data) ED-HTS Clients
- Age less than 18 years
- Not able and willing to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HIV Enhanced Access Testing in Emergency Department Program Using a Systems Analysis and Improvement Approach (HEATED-SAIA) Cluster Randomized Trial
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.
Read the 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 persons also often have higher-risk profiles for HIV making them priority 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), 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 status-neutral care settings, ED-HTS may have fewer stigmatization barriers than conventional service delivery points (SDPs) to support 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 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 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 improve delivery of evidence-based HTS for 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 target 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.
- Conditions
- HIV
- Being tested
- Systems Analysis and Improvement Approach (SAIA)
- Keywords
- HIV, SAIA, Emergency Care, Africa, Kenya, Emergency Services, HIV Testing Services, Systems Analysis and Improvement Approach, Implementation Science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Systems Analysis and Improvement Approach (SAIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach: Staff Engagement
- Proportion of personnel taking part in SAIA cycles (intervention sites)
- Representativeness of staff taking part in SAIA cycles planning (intervention sites)
Measured: Quarterly (3-42 months)
Reach: Patient Participation
- Proportion of ED patients accepting referral for HTS among those screened \& eligible (intervention versus control sites)
- Proportion of ED patients accepting referral for HTS for target populations of men and AYA among those screened \& eligible (intervention versus control sites)
Measured: Quarterly (3-42 months)
Effectiveness: HIV Testing Delivery
- Proportion of ED patients completing testing among patients appropriate for testing (intervention versus control sites)
- Proportion of ED patients completing testing among target populations men and AYA appropriate for testing (intervention versus control sites)
- Proportion of ED persons from KPs completing testing (intervention versus control sites)
Measured: Quarterly (3-42 months)
Effectiveness: Linkage to Care for People Living with HIV
- Proportion of ED patients tested identified as PLH linked to HIV care (intervention versus control sites)
- Proportion of ED patients tested identified as PLH linked to HIV care among target populations of men and AYA (intervention versus control sites)
- Proportion of ED persons from KPs tested identified as PLH linked to HIV care (intervention versus control sites)
Measured: Quarterly (3-42 months)
Effectiveness: PrEP Screening & Referral
- Proportion of ED patients testing negative screened and referred for PrEP (intervention versus control sites)
- Proportion of ED patients testing negative among target populations of men and AYA screened and referred for PrEP (intervention versus control sites)
- Proportion of ED persons from KPs testing negative screened and referred for PrEP (intervention site versus controls)
Measured: 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)
Measured: Months: 1, 3 & 15
Adoption: Staff Intentions
Organizational climate and professional behaviors for ED and HTS personnel on HEATED-SAIA program (intervention sites)
Measured: Months: 1, 6, 9 & 15
Implementation: Feasibility
- Proportion of micro-strategies/cycle delivered subsequent cycle (intervention sites)
- Proportion of micro-strategies identified and adopted from all HEATED-SAIA cycles delivered in the facility for >6 months (intervention sites)
- Integrated IRLM-CFIR qualitative data \& coincidence analysis of micro-strategies (intervention sites)
Measured: 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)
Measured: 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)
Measured: Months: 3, 15, 24 & 40
Maintenance: Sustainability
- Continuation of HEATED-SAIA cycles with >3 per 6 months (intervention site)
- 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)
Measured: 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)
Measured: 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
Measured: months 3, 15 & 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Feb 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster parallel trial with a baseline measurement period.
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Brown University
- Responsible party
- Principal investigator, Adam Aluisio, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747221
- Sponsor's protocol ID
- 2232153
- Acronym
- HEATED-SAIA
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aluisio AR, Loevinsohn G, Chondo E, Nderitu A, Bruba M, Adam A, Baird J, Galarraga O, Wilson-Barthes M, Sarker M, Mandaliya K, Kinuthia J, Bosire R, Wachira B, Gross Z, Cherutich P, Wanje G, McClelland RS, Eastment MC. Study protocol for the: HIV enhanced access testing in emergency department program using a systems analysis and improvement approach (HEATED-SAIA) cluster randomized trial. Implement Sci Commun. 2026 May 19;7(1):104. doi: 10.1186/s43058-026-00964-5.
PubMed 42157232
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Enhanced Access Testing in Emergency Department Program Using a Systems Analysis and Improvement Approach (HEATED-SAIA) Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06747221
- Acronym / sponsor ID
- HEATED-SAIA / 2232153
- Conditions
- HIV
- Keywords
- HIV, SAIA, Emergency Care, Africa, Kenya, Emergency Services, HIV Testing Services, Systems Analysis and Improvement Approach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Washington, Brown University
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 persons also often have higher-risk profiles for HIV making them priority 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), 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 status-neutral care settings, ED-HTS may have fewer stigmatization barriers than conventional service delivery points (SDPs) to support 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 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 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 improve delivery of evidence-based HTS for 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 target 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cluster parallel trial with a baseline measurement period.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Systems Analysis and Improvement Approach (SAIA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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
Key exclusion criteria (10 listed)
- 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 not working at a Kenya public health facilities randomized to the control or intervention arm in Kwale, Mombassa and Kilifi Counties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systems Analysis and Improvement Approach (SAIA)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). | Other | Standard care |
Primary outcome
Reach: Staff Engagement
Time frame: Quarterly (3-42 months)
1. Proportion of personnel taking part in SAIA cycles (intervention sites) 2. Representativeness of staff taking part in SAIA cycles planning (intervention sites)
Reach: Patient Participation
Time frame: Quarterly (3-42 months)
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)
Effectiveness: HIV Testing Delivery
Time frame: Quarterly (3-42 months)
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)
Effectiveness: Linkage to Care for People Living with HIV
Time frame: Quarterly (3-42 months)
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)
Effectiveness: PrEP Screening & Referral
Time frame: Quarterly (3-42 months)
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)
Adoption: Uptake Determinants
Time frame: Months: 1, 3 & 15
IRLM-CFIR qualitative data to understand HEATED-SAIA determinants of uptake (Primary SAIA Facilitators, Primary SAIA Implementers, DOH Personnel)
Adoption: Staff Intentions
Time frame: Months: 1, 6, 9 & 15
Organizational climate and professional behaviors for ED and HTS personnel on HEATED-SAIA program (intervention sites)
Implementation: Feasibility
Time frame: Monthly (3-42 months)
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)
Implementation: Fidelity
Time frame: Months: 3, 15, & 40
Qualitative data using IRLM-CFIR to understand HEATED-SAIA cycle fidelity (Primary SAIA Implementers at intervention site) (intervention sites)
Implementation: Facilitators & Barriers
Time frame: Months: 3, 15, 24 & 40
IRLM-CFIR qualitative data on facilitators and barriers of HEATED-SAIA cycle completion (Primary SAIA Facilitators, Primary SAIA Implementers, DOH Personnel, ED-HTS clients)
Maintenance: Sustainability
Time frame: Months: 24, 30, 36 & 42
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)
Maintenance: Penetration
Time frame: Months: 24 & 40
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)
Economic evaluation: ED-HTS and implementation of the HEATED-SAIA program
Time frame: months 3, 15 & 21
Micro-costing and time-and-motion costing for ED-HTS programing (baseline) and HEATED-SAIA programming
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 42157232Aluisio AR, Loevinsohn G, Chondo E, Nderitu A, Bruba M, Adam A, Baird J, Galarraga O, Wilson-Barthes M, Sarker M, Mandaliya K, Kinuthia J, Bosire R, Wachira B, Gross Z, Cherutich P, Wanje G, McClelland RS, Eastment MC. Study protocol for the: HIV enhanced access testing in emergency department program using a systems analysis and improvement approach (HEATED-SAIA) cluster randomized trial. Implement Sci Commun. 2026 May 19;7(1):104. doi: 10.1186/s43058-026-00964-5.
- Individual participant dataSharing planned: Undecided
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Systems Analysis and Improvement Approach (SAIA) in people with HIV, run by Rhode Island Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Aluisio, MD, MSc, DTM&H (1-401-444-9891, adam_aluisio@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach: Staff Engagement (time frame: Quarterly (3-42 months)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.