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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI147752 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Centre for the AIDS Programme of Research in South Africa | NETWORK |
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This study seeks to determine the clinical efficacy and cost effectiveness of implementing an integrated model for HIV monitoring using point of care (POC) tenofovir (TFV) adherence testing and POC viral load (VL) monitoring in improving ART adherence, maintaining durable VL suppression, and improving retention in care among HIV-positive individuals initiating first-line tenofovir disoproxil fumarate (TDF)-based ART in South Africa.
This study will be a two-arm, open-label, randomized controlled superiority trial at an HIV clinic in Durban. HIV-positive individuals aged 16 years and above, who are initiating a tenofovir-based, first-line ART will be randomized to receive POC VL testing and POC TFV adherence testing, versus standard-of-care (SoC) viral load testing. The schedule for VL testing and management of VL test results will follow South African guidelines for HIV VL testing after ART initiation. 540 participants will be randomized (1:1) at ART initiation into the intervention arm (routine POC TFV adherence testing with POC VL monitoring) or the standard-of-care (SoC) arm (no objective TFV adherence testing and SoC VL monitoring).
Participants will be followed to compare concentrations between study arms at 24 weeks after ART initiation and a composite outcome of VL suppression and retention in care between the study arms at 72 weeks after ART initiation. The study will use process evaluation data, interviews and focus groups with patients and staff to assess implementation of the POC assays. Micro-costing will be conducted to estimate intervention costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Point-of-care urine adherence testing and Point-of-care viral load testing. Detailed: Monthly urine TFV testing with adherence counselling for the first 5 months; POC VL testing at Month 6 and 12 with reflex urine TFV testing for VL >200 copies/mL and HIV drug resistance testing if TFV test indicated adherence. |
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| Standard-of-care arm | No Intervention | Without POC urine adherence testing and POC viral load testing. Detailed: routine adherence counseling and lab-based viral load testing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-care viral load testing and tenofovir adherence testing | Combination Product | Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks | We will measure viral load by a laboratory-based reference assay, performed by the South African National Health Laboratory Services. Viral suppression will be defined as a viral load <200 copies/mL. This outcome will also include retention in care. | 72 weeks after ART initiation |
| Tenofovir Diphosphate Concentration Level >=700 Fmol/Punch in Dried Blood Spots | We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry. | 72 weeks after ART initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Point-of-care Tenofovir and Viral Load Testing | We will assess acceptability of point-of-care tenofovir and viral load testing by conducting semi-structured in-depth interviews and focus group discussions with study participants. | 24 and 72 weeks after ART initiation |
| Cost-effectiveness of Providing Routine Point-of-care Tenofovir and Viral Load Testing as Compared to Standard-of-care Viral Load Monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Drain, MD, MPH | University of Washington | Principal Investigator |
| Nigel Garett, MBBS, PHD | Centre for the AIDS Programme of Research in South Africa (CAPRISA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal | Durban | KwaZulu-Natal | 4013 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40660747 | Derived | Wang M, Moodley P, Khanyile M, Bulo E, Zondi M, Naidoo K, Sookrajh Y, Dorward J, Gandhi M, Garrett N, Drain PK, Sharma M. Cost and clinical flow of point-of-care urine tenofovir testing for treatment monitoring among people living with HIV initiating ART in South Africa. J Int AIDS Soc. 2025 Jul;28(7):e70004. doi: 10.1002/jia2.70004. | |
| 34610939 | Derived | Bardon AR, Dorward J, Sookrajh Y, Sayed F, Quame-Amaglo J, Pillay C, Feutz E, Ngobese H, Simoni JM, Sharma M, Cressey TR, Gandhi M, Lessells R, Moodley P, Naicker N, Naidoo K, Thomas K, Celum C, Abdool Karim S, Garrett N, Drain PK. Simplifying TREAtment and Monitoring for HIV (STREAM HIV): protocol for a randomised controlled trial of point-of-care urine tenofovir and viral load testing to improve HIV outcomes. BMJ Open. 2021 Oct 5;11(10):e050116. doi: 10.1136/bmjopen-2021-050116. |
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De-identified data from the study will be made available
Beginning 9 months and ending 36 months following publication of primary results.
De-identified data generated under this project will be administered in accordance with University of Washington, CAPRISA, and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance of March 5, 2003.
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The initial enrollment was planned for 540. However, one person was considered ineligible after enrollment. Therefore, this person was not enrolled per-protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | Point-of-care urine adherence testing and Point-of-care viral load testing. Detailed: Monthly urine TFV testing with adherence counselling for the first 5 months; POC VL testing at Month 6 and 12 with reflex urine TFV testing for VL >200 copies/mL and HIV drug resistance testing if TFV test indicated adherence. Point-of-care test results were provided to participants on the same day as specimen collection, if/when possible. |
| FG001 | Standard-of-care Arm | Without POC urine adherence testing and POC viral load testing. Detailed: routine adherence counseling and lab-based viral load testing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Arm | Point-of-care urine adherence testing and Point-of-care viral load testing. Detailed: Monthly urine TFV testing with adherence counselling for the first 5 months; POC VL testing at Month 6 and 12 with reflex urine TFV testing for VL >200 copies/mL and HIV drug resistance testing if TFV test indicated adherence. Point-of-care viral load testing and tenofovir adherence testing: Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Viral Load Suppression (<200 Copies/ml) and Retained in Care at 72 Weeks | We will measure viral load by a laboratory-based reference assay, performed by the South African National Health Laboratory Services. Viral suppression will be defined as a viral load <200 copies/mL. This outcome will also include retention in care. | Number of study participants who have data for the comparison of viral load suppression (<200 copies/ml) and retention in care at 72 weeks after ART initiation. | Posted | Count of Participants | Participants | 72 weeks after ART initiation |
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Each participant was evaluated for AEs from study enrollment through the exit visit after an approximate 18-month follow-up period.
All adverse event were collected using the NIH standardized definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Arm | Point-of-care urine adherence testing and Point-of-care viral load testing. Detailed: Monthly urine TFV testing with adherence counselling for the first 5 months; POC VL testing at Month 6 and 12 with reflex urine TFV testing for VL >200 copies/mL and HIV drug resistance testing if TFV test indicated adherence. Point-of-care test results were provided to participants on the same day as specimen collection, if/when possible. |
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There was a high rate of loss-to-follow-up in this study, which limited the number of participants who provided blood specimens for HIV viral load and tenofovir drug concentration testing at the end of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Morton, Project Manager | University of Washington | 206-520-3820 | jfmorton@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2020 | Nov 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2023 | Nov 4, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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We will conduct a micro-costing of the costs associated with point-of-care tenofovir and viral load testing and will estimate the cost-effectiveness of the intervention using an existing individual-based, stochastic HIV model for KwaZulu-Natal for simulating health and economic outcomes. |
| 24 and 72 weeks after ART initiation |
| BG001 | Standard-of-care Arm | Without POC urine adherence testing and POC viral load testing. Detailed: routine adherence counseling and lab-based viral load testing. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Standard-of-care Arm | Without POC urine adherence testing and POC viral load testing. Detailed: routine adherence counseling and lab-based viral load testing. |
|
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| Primary | Tenofovir Diphosphate Concentration Level >=700 Fmol/Punch in Dried Blood Spots | We will measure tenofovir-diphosphate concentrations in 3mm dried blood spots using liquid chromatography/tandem mass spectrometry. | Note: We were not able to collect a dried blood spot (DBS) specimen on people who were not retained in care or refused to provide a sample. Therefore, the denominator reflects testing on those people where were retained in the study and able to provide a fingerprick blood sample. | Posted | Count of Participants | Participants | 72 weeks after ART initiation |
|
|
|
| Secondary | Acceptability of Point-of-care Tenofovir and Viral Load Testing | We will assess acceptability of point-of-care tenofovir and viral load testing by conducting semi-structured in-depth interviews and focus group discussions with study participants. | Not Posted | 24 and 72 weeks after ART initiation | Participants |
| Secondary | Cost-effectiveness of Providing Routine Point-of-care Tenofovir and Viral Load Testing as Compared to Standard-of-care Viral Load Monitoring | We will conduct a micro-costing of the costs associated with point-of-care tenofovir and viral load testing and will estimate the cost-effectiveness of the intervention using an existing individual-based, stochastic HIV model for KwaZulu-Natal for simulating health and economic outcomes. | Not Posted | 24 and 72 weeks after ART initiation | Participants |
| 5 |
| 270 |
| 0 |
| 270 |
| 0 |
| 270 |
| EG001 | Standard-of-care Arm | Without POC urine adherence testing and POC viral load testing. Detailed: routine adherence counseling and lab-based viral load testing. | 5 | 269 | 0 | 269 | 0 | 269 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |