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
<p><strong>Background:</strong> Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings. The aim of our study was to determine whether point-of-care HIV viral load testing with task shifting changed treatment an...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Elsevier
2020
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| _version_ | 1797106163309871104 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Drain, PK |
| collection | OXFORD |
| description | <p><strong>Background:</strong> Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings. The aim of our study was to determine whether point-of-care HIV viral load testing with task shifting changed treatment and care outcomes for adults on antiretroviral therapy (ART) when compared with standard laboratory viral load testing.</p>
<p><strong>Methods:</strong> We did an open-label, non-inferiority, randomised controlled trial in a public clinic in Durban, South Africa. We enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation. Individuals were randomly assigned by a random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group). The primary outcome was combined viral suppression (<200 copies per mL) and retention at 12 months after enrolment. A non-inferiority margin of 10% was used. Analysis was done by intention to treat. This study was registered with ClinicalTrials.gov, NCT03066128.</p>
<p><strong>Findings:</strong> Between Feb 24, 2017, and Aug 23, 2017, we screened 657 participants, and 390 were enrolled and randomly assigned to either the intervention group (n=195) or standard-of-care group (n=195). 175 (90%) individuals in the intervention group and 148 (76%) individuals in the standard-of-care group had the primary outcome of retention with viral suppression, a difference of 13·9% (95% CI 6·4–21·2; p<0·00040). 182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9–16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3–14·2; p=0·026). There were no adverse events related to point-of-care HIV viral load testing or task shifting.</p>
<p><strong>Interpretation:</strong> Point-of-care viral load testing combined with task shifting significantly improved viral suppression and retention in HIV care. Point-of-care testing can simplify treatment and improve outcomes for HIV-positive adults receiving ART in resource-limited settings.</p>
<p><strong>Funding:</strong> National Institute of Allergy and Infectious Diseases.</p> |
| first_indexed | 2024-03-07T06:57:49Z |
| format | Journal article |
| id | oxford-uuid:febbefa8-21a7-4b67-97e7-a4f4ccec9307 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T06:57:49Z |
| publishDate | 2020 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | oxford-uuid:febbefa8-21a7-4b67-97e7-a4f4ccec93072022-03-27T13:38:57ZPoint-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:febbefa8-21a7-4b67-97e7-a4f4ccec9307EnglishSymplectic ElementsElsevier2020Drain, PKDorward, JViolette, LRQuame-Amaglo, JThomas, KKSamsunder, NNgobese, HMlisana, KMoodley, PDonnell, DBarnabas, RVNaidoo, KAbdool-Karim, SSCelum, CGarrett, N<p><strong>Background:</strong> Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings. The aim of our study was to determine whether point-of-care HIV viral load testing with task shifting changed treatment and care outcomes for adults on antiretroviral therapy (ART) when compared with standard laboratory viral load testing.</p> <p><strong>Methods:</strong> We did an open-label, non-inferiority, randomised controlled trial in a public clinic in Durban, South Africa. We enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation. Individuals were randomly assigned by a random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group). The primary outcome was combined viral suppression (<200 copies per mL) and retention at 12 months after enrolment. A non-inferiority margin of 10% was used. Analysis was done by intention to treat. This study was registered with ClinicalTrials.gov, NCT03066128.</p> <p><strong>Findings:</strong> Between Feb 24, 2017, and Aug 23, 2017, we screened 657 participants, and 390 were enrolled and randomly assigned to either the intervention group (n=195) or standard-of-care group (n=195). 175 (90%) individuals in the intervention group and 148 (76%) individuals in the standard-of-care group had the primary outcome of retention with viral suppression, a difference of 13·9% (95% CI 6·4–21·2; p<0·00040). 182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9–16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3–14·2; p=0·026). There were no adverse events related to point-of-care HIV viral load testing or task shifting.</p> <p><strong>Interpretation:</strong> Point-of-care viral load testing combined with task shifting significantly improved viral suppression and retention in HIV care. Point-of-care testing can simplify treatment and improve outcomes for HIV-positive adults receiving ART in resource-limited settings.</p> <p><strong>Funding:</strong> National Institute of Allergy and Infectious Diseases.</p> |
| spellingShingle | 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
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