Fact CheckerSign in

NCT06747221Not yet recruiting

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

HIV Enhanced Access Testing in Emergency Department Program Using a Systems Analysis and Improvement Approach (HEATED-SAIA) Cluster Randomized Trial

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
184 (estimated)
First submitted
18 Dec 2024
Start date
1 Feb 2027
Primary completion date
30 Jun 2028
Lead sponsor
Rhode Island Hospital
Diseases
HIV
NCT number
NCT06747221

What you commit to

  • Study type: Interventional
  • Planned participants: 184
  • From 1 Feb 2027 to the primary completion date, 30 Jun 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Kenya public health facilities in Kwale, Mombassa and Kilifi Counties without existing HIV testing services
    • Participant Level (Qualitative Data) Healthcare Personnel

Age

  • Age less than 18 years
  • Age less than 18 years

Other

  • Private health facilities
  • Kenya public health facilities in Kwale, Mombassa and Kilifi Counties without an active emergency department
  • Personnel not working at a Kenya public health facilities randomized to the control or intervention arm in Kwale, Mombassa and Kilifi Counties
  • Not able and willing to provide informed consent
    • Participant Level (Qualitative Data) ED-HTS Clients
  • Not able and willing to provide informed consent

Who the study is looking for

  • 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
  • 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

Criteria the registry did not label

  • Facility Level (Quantitative De-identified Systems Data)

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.