- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03066128
Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care (STREAM)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KwaZulu-Natal
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Durban, KwaZulu-Natal, South Africa, 4013
- Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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.
|
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
|
Experimental: Standard of Care
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
|
Viral load testing will be lab based and follow standard of care procedures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite measure of virological suppression and retention in care
Time Frame: 12 months post enrollment
|
HIV VL <200 copies/mL at 12-month study visit
|
12 months post enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion retained in care
Time Frame: 12 months post enrollment
|
Proportion of patients collecting ART at the 12-month study visit
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12 months post enrollment
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Time to detection
Time Frame: Every 2 months within the 12-month follow up period
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Time to detection of virological failure, subsequent intensive adherence counselling, and initiation of second line regimen
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Every 2 months within the 12-month follow up period
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Entry into CCMDD
Time Frame: Every 2 months between 6 and 12 months post enrollment
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Proportion of patients entered appropriately into CCMDD, and time to appropriate entry into CCMDD
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Every 2 months between 6 and 12 months post enrollment
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Average cost per HIV-positive client
Time Frame: 12 months post enrollment
|
Average cost per HIV-positive client achieving viral suppression and retained in care
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12 months post enrollment
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Number of clinical visits
Time Frame: 12 months post enrollment
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Mean number of clinical visits per patient
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12 months post enrollment
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Loss to follow up or mortality
Time Frame: 12 months post enrollment
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Proportion lost to follow up or deceased
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12 months post enrollment
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Change in CD4 count
Time Frame: 12 months post enrollment
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Mean change in CD4 count from enrolment to 12-month study exit visit
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12 months post enrollment
|
Proportion on same ART regimen
Time Frame: 12 months post enrollment
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Proportion of patients collecting ART at the 12-month study visit
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12 months post enrollment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nigel Garrett, MBBS, MSc, Centre for the AIDS Programme of Research in South Africa (CAPRISA)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001466
- R21AI124719 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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