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Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care (STREAM)

Primary Purpose

Chronic HIV Infection

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Point-of-care viral load testing
Lab-based viral load testing
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic HIV Infection focused on measuring Task shifting, HIV care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-infected and receiving antiretroviral therapy (ART)
  • Receiving care at Prince Cyril Zulu Clinic in Durban
  • Stable on Current ART Regimen and due the 6 month follow-up visit post ART initiation
  • Willing/able to provide written informed consent to participate in the stud

Exclusion Criteria:

  • Have significant signs/symptoms of illness that requires active medical care by a clinic doctor.
  • Does not plan to receive HIV care at the Prince Cyril Zulu Communicable Diseases Clinic for the following 12 months.
  • Currently pregnant

Sites / Locations

  • Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Standard of Care

Arm Description

Participants in the Intervention Group will receive chronic ART management from a Professional Nurse and/or Enrolled Nurse every 2 months, and if stable after 6 months, community pharmacy ART collection through CCMDD. Viral load monitoring will be by a point-of-care viral load testing.

Participants in the Standard-of-Care 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 by lab-based viral load testing

Outcomes

Primary Outcome Measures

Composite measure of virological suppression and retention in care
HIV VL <200 copies/mL at 12-month study visit

Secondary Outcome Measures

Proportion retained in care
Proportion of patients collecting ART at the 12-month study visit
Time to detection
Time to detection of virological failure, subsequent intensive adherence counselling, and initiation of second line regimen
Entry into CCMDD
Proportion of patients entered appropriately into CCMDD, and time to appropriate entry into CCMDD
Average cost per HIV-positive client
Average cost per HIV-positive client achieving viral suppression and retained in care
Number of clinical visits
Mean number of clinical visits per patient
Loss to follow up or mortality
Proportion lost to follow up or deceased
Change in CD4 count
Mean change in CD4 count from enrolment to 12-month study exit visit
Proportion on same ART regimen
Proportion of patients collecting ART at the 12-month study visit

Full Information

First Posted
February 22, 2017
Last Updated
February 5, 2020
Sponsor
University of Washington
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03066128
Brief Title
Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care
Acronym
STREAM
Official Title
Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 investigator's 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 symptoms/signs of tuberculosis, other opportunistic infections, and ART side effects at each clinical encounter. Participants who have a high lab-based HIV VL (≥1,000 copies/mL) 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 (≥1,000 copies/mL) 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 and/or 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 Nurse/MO 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 (≥1,000 copies/mL) 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 (≥1,000 copies/mL) 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 Africa's 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 v.2.0 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 (e.g. 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, i.e. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic HIV Infection
Keywords
Task shifting, HIV care

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in the Intervention Group will receive chronic ART management from a Professional Nurse and/or Enrolled Nurse every 2 months, and if stable after 6 months, community pharmacy ART collection through CCMDD. Viral load monitoring will be by a point-of-care viral load testing.
Arm Title
Standard of Care
Arm Type
Experimental
Arm Description
Participants in the Standard-of-Care 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 by lab-based viral load testing
Intervention Type
Diagnostic Test
Intervention Name(s)
Point-of-care viral load testing
Intervention Description
Point-of-care viral load testing will be performed while the participant is in the clinic to ensure that participants receive the viral load results on the same day
Intervention Type
Other
Intervention Name(s)
Lab-based viral load testing
Intervention Description
Viral load testing will be lab based and follow standard of care procedures
Primary Outcome Measure Information:
Title
Composite measure of virological suppression and retention in care
Description
HIV VL <200 copies/mL at 12-month study visit
Time Frame
12 months post enrollment
Secondary Outcome Measure Information:
Title
Proportion retained in care
Description
Proportion of patients collecting ART at the 12-month study visit
Time Frame
12 months post enrollment
Title
Time to detection
Description
Time to detection of virological failure, subsequent intensive adherence counselling, and initiation of second line regimen
Time Frame
Every 2 months within the 12-month follow up period
Title
Entry into CCMDD
Description
Proportion of patients entered appropriately into CCMDD, and time to appropriate entry into CCMDD
Time Frame
Every 2 months between 6 and 12 months post enrollment
Title
Average cost per HIV-positive client
Description
Average cost per HIV-positive client achieving viral suppression and retained in care
Time Frame
12 months post enrollment
Title
Number of clinical visits
Description
Mean number of clinical visits per patient
Time Frame
12 months post enrollment
Title
Loss to follow up or mortality
Description
Proportion lost to follow up or deceased
Time Frame
12 months post enrollment
Title
Change in CD4 count
Description
Mean change in CD4 count from enrolment to 12-month study exit visit
Time Frame
12 months post enrollment
Title
Proportion on same ART regimen
Description
Proportion of patients collecting ART at the 12-month study visit
Time Frame
12 months post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV-infected and receiving antiretroviral therapy (ART) Receiving care at Prince Cyril Zulu Clinic in Durban Stable on Current ART Regimen and due the 6 month follow-up visit post ART initiation Willing/able to provide written informed consent to participate in the stud Exclusion Criteria: Have significant signs/symptoms of illness that requires active medical care by a clinic doctor. Does not plan to receive HIV care at the Prince Cyril Zulu Communicable Diseases Clinic for the following 12 months. Currently pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Drain, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nigel Garrett, MBBS, MSc
Organizational Affiliation
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4013
Country
South Africa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all outcome measures will be made available after study completion
Citations:
PubMed Identifier
28963304
Citation
Dorward J, Garrett N, Quame-Amaglo J, Samsunder N, Ngobese H, Ngomane N, Moodley P, Mlisana K, Schaafsma T, Donnell D, Barnabas R, Naidoo K, Abdool Karim S, Celum C, Drain PK. Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study. BMJ Open. 2017 Sep 27;7(9):e017507. doi: 10.1136/bmjopen-2017-017507.
Results Reference
background
PubMed Identifier
33239012
Citation
Msimango L, Gibbs A, Shozi H, Ngobese H, Humphries H, Drain PK, Garrett N, Dorward J. Acceptability of point-of-care viral load testing to facilitate differentiated care: a qualitative assessment of people living with HIV and nurses in South Africa. BMC Health Serv Res. 2020 Nov 25;20(1):1081. doi: 10.1186/s12913-020-05940-w.
Results Reference
derived
PubMed Identifier
32414827
Citation
Dorward J, Msimango L, Gibbs A, Shozi H, Tonkin-Crine S, Hayward G, Butler CC, Ngobese H, Drain PK, Garrett N. Understanding how community antiretroviral delivery influences engagement in HIV care: a qualitative assessment of the Centralised Chronic Medication Dispensing and Distribution programme in South Africa. BMJ Open. 2020 May 15;10(5):e035412. doi: 10.1136/bmjopen-2019-035412.
Results Reference
derived
PubMed Identifier
32105625
Citation
Drain PK, Dorward J, Violette LR, Quame-Amaglo J, Thomas KK, Samsunder N, Ngobese H, Mlisana K, Moodley P, Donnell D, Barnabas RV, Naidoo K, Abdool Karim SS, Celum C, Garrett N. Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial. Lancet HIV. 2020 Apr;7(4):e229-e237. doi: 10.1016/S2352-3018(19)30402-3. Epub 2020 Feb 24.
Results Reference
derived
PubMed Identifier
31663368
Citation
Dorward J, Drain PK, Osman F, Sookrajh Y, Pillay M, Moodley P, Garrett N. Short Communication: Early Antiretroviral Therapy Is Associated with Better Viral Suppression and Less HIV Drug Resistance After Implementation of Universal Treatment in South Africa. AIDS Res Hum Retroviruses. 2020 Apr;36(4):297-299. doi: 10.1089/AID.2019.0206. Epub 2019 Dec 4.
Results Reference
derived
PubMed Identifier
29271830
Citation
Dorward J, Yende-Zuma N, Samsunder N, Karim QA, Drain PK, Garrett N. Clinic-Based Evaluation of a Point-of-Care Creatinine Assay to Screen for Renal Impairment Among HIV-Positive Patients Receiving Tenofovir Disoproxil Fumarate. J Acquir Immune Defic Syndr. 2018 Apr 1;77(4):e36-e39. doi: 10.1097/QAI.0000000000001613. No abstract available.
Results Reference
derived

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Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care

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