Chronic HIV InfectionSTREAMNCT03066128
Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care
A study testing Point-of-care viral load testing and Lab-based viral load testing in people with Chronic HIV Infection, run by University of Washington at 1 site in South Africa.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic HIV Infection
- What is being tested?
- Point-of-care viral load testing and Lab-based viral load testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteSouth Africa
- Study dates
- 24 Feb 2017to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal
Durban, KwaZulu-Natal, 4013
About this study
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.
Read the 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.
- Conditions
- Chronic HIV Infection
- Being tested
- Point-of-care viral load testing, Lab-based viral load testing
- Keywords
- Task shifting, HIV care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care viral load testingDiagnostic test
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
Lab-based viral load testingOther
Viral load testing will be lab based and follow standard of care procedures
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Diagnostic Test: Point-of-care viral load testing |
| Standard of Care | Experimental | 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 Receives: Other: Lab-based viral load testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of virological suppression and retention in care
HIV VL <200 copies/mL at 12-month study visit
Measured: 12 months post enrollment
Secondary outcomes (8)
Proportion retained in care
Proportion of patients collecting ART at the 12-month study visit
Measured: 12 months post enrollment
Time to detection
Time to detection of virological failure, subsequent intensive adherence counselling, and initiation of second line regimen
Measured: Every 2 months within the 12-month follow up period
Entry into CCMDD
Proportion of patients entered appropriately into CCMDD, and time to appropriate entry into CCMDD
Measured: Every 2 months between 6 and 12 months post enrollment
Average cost per HIV-positive client
Average cost per HIV-positive client achieving viral suppression and retained in care
Measured: 12 months post enrollment
Number of clinical visits
Mean number of clinical visits per patient
Measured: 12 months post enrollment
Loss to follow up or mortality
Proportion lost to follow up or deceased
Measured: 12 months post enrollment
Change in CD4 count
Mean change in CD4 count from enrolment to 12-month study exit visit
Measured: 12 months post enrollment
Proportion on same ART regimen
Proportion of patients collecting ART at the 12-month study visit
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start24 Feb 2017
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Drain, University of Washington
- Investigators
- Paul Drain, MD, MPH, Principal investigator, University of WashingtonNigel Garrett, MBBS, MSc, Principal investigator, Centre for the AIDS Programme of Research in South Africa (CAPRISA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066128
- Sponsor's protocol ID
- STUDY00001466
- Other IDs
- R21AI124719
- Acronym
- STREAM
- Status last verified
- Feb 2020
- First submitted
- 22 Feb 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all outcome measures will be made available after study completion
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.
PubMed 28963304Wang M, Violette LR, Dorward J, Ngobese H, Sookrajh Y, Bulo E, Quame-Amaglo J, Thomas KK, Garrett N, Drain PK. Delivery of Community-based Antiretroviral Therapy to Maintain Viral Suppression and Retention in Care in South Africa. J Acquir Immune Defic Syndr. 2023 Jun 1;93(2):126-133. doi: 10.1097/QAI.0000000000003176.
PubMed 36796353Msimango 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.
PubMed 33239012Dorward 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.
PubMed 32414827Drain 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.
PubMed 32105625Dorward 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.
PubMed 31663368Dorward 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.
PubMed 29271830
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care
- ClinicalTrials.gov ID
- NCT03066128
- Acronym / sponsor ID
- STREAM / STUDY00001466
- Conditions
- Chronic HIV Infection
- Keywords
- Task shifting, HIV care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 28 Feb 2017 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Point-of-care viral load testingParticipants 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. |
| Standard of Care | Experimental | Other: Lab-based viral load testingParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Point-of-care viral load testingPoint-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 | Diagnostic test | Intervention |
| Lab-based viral load testingViral load testing will be lab based and follow standard of care procedures | Other | Standard of Care |
Primary outcome
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
8 secondary outcomes
Proportion retained in care
Time frame: 12 months post enrollment
Time to detection
Time frame: Every 2 months within the 12-month follow up period
Entry into CCMDD
Time frame: Every 2 months between 6 and 12 months post enrollment
Average cost per HIV-positive client
Time frame: 12 months post enrollment
Number of clinical visits
Time frame: 12 months post enrollment
Loss to follow up or mortality
Time frame: 12 months post enrollment
Change in CD4 count
Time frame: 12 months post enrollment
Proportion on same ART regimen
Time frame: 12 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 28963304Dorward 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.
- Derived from this study: PubMed 36796353Wang M, Violette LR, Dorward J, Ngobese H, Sookrajh Y, Bulo E, Quame-Amaglo J, Thomas KK, Garrett N, Drain PK. Delivery of Community-based Antiretroviral Therapy to Maintain Viral Suppression and Retention in Care in South Africa. J Acquir Immune Defic Syndr. 2023 Jun 1;93(2):126-133. doi: 10.1097/QAI.0000000000003176.
- Derived from this study: PubMed 33239012Msimango 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.
- Derived from this study: PubMed 32414827Dorward 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.
- Derived from this study: PubMed 32105625Drain 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.
- Derived from this study: PubMed 31663368Dorward 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.
- Derived from this study: PubMed 29271830Dorward 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all outcome measures will be made available after study completion
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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. This study is not recruiting at the moment.
Paul Drain, MD, MPH principal investigator
University of Washington
Nigel Garrett, MBBS, MSc principal investigator
Centre for the AIDS Programme of Research in South Africa (CAPRISA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care viral load testing and Lab-based viral load testing in people with Chronic HIV Infection, run by University of Washington at 1 site in South Africa.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measure of virological suppression and retention in care (time frame: 12 months post enrollment). 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 NCT03066128, which also lists 7 linked publications.
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 7 Feb 2020.