Ignite Creation Date:
2024-05-06 @ 9:44 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03066128
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2017-02-22
Brief Title:
Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STREAM
Brief Summary:
Effective management of patients on antiretroviral therapy ART is essential to improve clinical outcomes and prevent HIV transmission but monitoring life-long ART for over 15 million HIV-infected people has become a challenge particularly in low- and middle-income countries LMICs As programs continue to focus on identifying HIV-infected people and starting ART at higher CD4 thresholds HIV providers have been overburdened which has resulted in falling retention rates As ART coverage scales up to include millions more people additional strain will be placed on HIV clinicians and laboratories to manage stable patients on chronic ART Implementing point-of-care HIV VL testing to enable task shifting to nurses for chronic HIV care may help mitigate these burdens Point-of-care Viral Load VL testing is intended to differentiate patients who are potentially failing on their ART so that they can be referred to the next level of care for possible ART regiment change from patients who are virally suppressed on ART and can be managed by nurses The investigators scientific objective is to test the clinical equivalence and reduced cost of implementing a model for chronic HIV care that uses a point-of-care HIV VL assay to enable streamlined care and task shifting among healthcare workers at an urban clinic in South Africa The central hypothesis is that rapid HIV VL testing implemented by nurses is an effective and cost-efficient strategy for management of chronic HIV infection in the majority of patients thereby allowing more resources to be directed at the minority of patients who need greater attention This work is innovative because it uses a randomized evaluation of an implementation model that combines a novel diagnostic point-of-care test with streamlined care and task shifting among healthcare workers compared to standard of care for chronic HIV care in a resource-limited setting This randomized trial will then form the basis of a larger multicountry proposal to demonstrate the clinical equivalence and cost-effectiveness of implementing an integrated point-of-care HIV VL testing and streamlined care model for chronic HIV care in LMICs If nurses using clinic-based HIV VL testing are cost-effective for achieving both viral suppression and retention in care among patients on ART then implementation of this chronic HIV care model would alleviate the strain on existing HIV providers and laboratories in LMICs
Detailed Description:
The study design will be an open-label randomized non-inferiority implementation trial with 2 study arms Patients will be enrolled when due their 6 month VL since initiating ART
Standard of Care Arm
Participants in the Standard-of-Care SOC control arm will receive the standard-of-care for the clinic consisting of visits with a professional clinician Physician or Professional Nurse and once stable community pharmacy ART collection through CCMDD Viral load monitoring will be lab-based Participants will be assessed for clinical symptomssigns of tuberculosis other opportunistic infections and ART side effects at each clinical encounter Participants who have a high lab-based HIV VL 1000 copiesmL will receive intensive adherence counseling and be asked to return to the clinic in 2 months for repeat HIV VL testing If the HIV VL remains high 1000 copiesmL after the 2 months of intensive adherence counseling then the patient will be switched to a second-line ART regimen by a physician
Intervention Arm
Participants in the Intervention Group will receive chronic ART management from a Professional Nurse andor Enrolled Nurse every 2 months and if stable after 6 months community pharmacy ART collection through CCMDD Viral load monitoring will be POC Enrolled Nurse visits will consist of a clinical symptom and ART side effect checklists and an ART adherence questionnaire which trigger up-referral to a Professional NurseMO where appropriate Point-of-care Xpert HIV-1 VL testing will be performed while the participant is in the clinic to ensure that participants receive the VL results on the same day Participants who have a high HIV VL 1000 copiesmL will be referred to a Professional Nurse As with the standard-of-care arm they will receive intensive adherence counseling and be asked to return to the clinic in 2 months for repeat point-of-care Xpert HIV-1 VL testing Participants who continue to have a high HIV VL 1000 copiesmL after 2 months of intensive adherence counseling will be switched to second-line ART by a physician
Participants will also be followed for a 12-month study period to assess the study outcome measures This study will follow all aspects of South Africas ART guidelines except stable patients randomized to the intervention arm will receive Nurse-based care and Xpert VL monitoring as a comparison to the standard of care
At the end of the 12-month study period all participants will have a repeat CD4 count and lab-based HIV VL testing by Roche Taqman v20 assay The lab-based HIV VL testing will be important to use the same HIV VL assay to compare the primary outcomes measures In addition the research team will evaluate the outcome of retention in care which will be defined as collecting ART refills at the study exit visit
Cost-Effectiveness Component
The investigators will use an activity-based micro-costing approach including time and motion studies to estimate the costs incurred and averted along with the primary study outcomes viral suppression and retention in care to estimate the cost per HIV-positive person virally suppressed and retained in care in the Intervention Group as compared to the Standard-of-Care Group
Time and motion studies will determine the nurse time necessary to conduct the point-of-care HIV VL testing and the clinical visit with a stable HIV-infected patient Time and motion studies will be conducted during study initiation and again when the intervention is running at full capacity An experienced research assistant will collect data on the time required to complete each step of the chronic care visit VL testing clinical assessment counseling for both study arms Initial results will be shared with the teams to implement strategies for improved efficiency Observing multiple visits will allow estimation of the average time taken for each step the time taken for research purposes eg data collection will be noted separately from the estimated time needed for monitoring Multiple staff will be observed to capture the range of time required for a successful real-time chronic HIV care Interviews with study staff will also quantify the effort required for each step of visit Through time and motion studies the number of participants who could be supported by a clinic will be estimated The staff time taken for the intervention captures the opportunity cost of the chronic care intervention ie staff time that could be spent on a different program The micro-costing data time and motion studies and clinical outcomes will be used to estimate the average cost per HIV-positive client achieving viral suppression and retained in care in the chronic care model compared to the standard of care
Standard of Care Arm
Participants in the Standard-of-Care SOC control arm will receive the standard-of-care for the clinic consisting of visits with a professional clinician Physician or Professional Nurse and once stable community pharmacy ART collection through CCMDD Viral load monitoring will be lab-based Participants will be assessed for clinical symptomssigns of tuberculosis other opportunistic infections and ART side effects at each clinical encounter Participants who have a high lab-based HIV VL 1000 copiesmL will receive intensive adherence counseling and be asked to return to the clinic in 2 months for repeat HIV VL testing If the HIV VL remains high 1000 copiesmL after the 2 months of intensive adherence counseling then the patient will be switched to a second-line ART regimen by a physician
Intervention Arm
Participants in the Intervention Group will receive chronic ART management from a Professional Nurse andor Enrolled Nurse every 2 months and if stable after 6 months community pharmacy ART collection through CCMDD Viral load monitoring will be POC Enrolled Nurse visits will consist of a clinical symptom and ART side effect checklists and an ART adherence questionnaire which trigger up-referral to a Professional NurseMO where appropriate Point-of-care Xpert HIV-1 VL testing will be performed while the participant is in the clinic to ensure that participants receive the VL results on the same day Participants who have a high HIV VL 1000 copiesmL will be referred to a Professional Nurse As with the standard-of-care arm they will receive intensive adherence counseling and be asked to return to the clinic in 2 months for repeat point-of-care Xpert HIV-1 VL testing Participants who continue to have a high HIV VL 1000 copiesmL after 2 months of intensive adherence counseling will be switched to second-line ART by a physician
Participants will also be followed for a 12-month study period to assess the study outcome measures This study will follow all aspects of South Africas ART guidelines except stable patients randomized to the intervention arm will receive Nurse-based care and Xpert VL monitoring as a comparison to the standard of care
At the end of the 12-month study period all participants will have a repeat CD4 count and lab-based HIV VL testing by Roche Taqman v20 assay The lab-based HIV VL testing will be important to use the same HIV VL assay to compare the primary outcomes measures In addition the research team will evaluate the outcome of retention in care which will be defined as collecting ART refills at the study exit visit
Cost-Effectiveness Component
The investigators will use an activity-based micro-costing approach including time and motion studies to estimate the costs incurred and averted along with the primary study outcomes viral suppression and retention in care to estimate the cost per HIV-positive person virally suppressed and retained in care in the Intervention Group as compared to the Standard-of-Care Group
Time and motion studies will determine the nurse time necessary to conduct the point-of-care HIV VL testing and the clinical visit with a stable HIV-infected patient Time and motion studies will be conducted during study initiation and again when the intervention is running at full capacity An experienced research assistant will collect data on the time required to complete each step of the chronic care visit VL testing clinical assessment counseling for both study arms Initial results will be shared with the teams to implement strategies for improved efficiency Observing multiple visits will allow estimation of the average time taken for each step the time taken for research purposes eg data collection will be noted separately from the estimated time needed for monitoring Multiple staff will be observed to capture the range of time required for a successful real-time chronic HIV care Interviews with study staff will also quantify the effort required for each step of visit Through time and motion studies the number of participants who could be supported by a clinic will be estimated The staff time taken for the intervention captures the opportunity cost of the chronic care intervention ie staff time that could be spent on a different program The micro-costing data time and motion studies and clinical outcomes will be used to estimate the average cost per HIV-positive client achieving viral suppression and retained in care in the chronic care model compared to the standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AI124719 | NIH | None | httpsreporternihgovquickSearchR21AI124719 |