Randomized Controlled Trial

. 2020 Apr;7(4):e229-e237.

doi: 10.1016/S2352-3018(19)30402-3. Epub 2020 Feb 24.

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

Affiliations

¹ Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA; Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA. Electronic address: pkdrain@uw.edu.
² Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
³ Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.
⁴ Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.
⁵ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
⁶ Prince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, South Africa.
⁷ School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa.
⁸ School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa; Department of Virology, Inkosi Albert Luthuli Central Hospital, Cato Manor, South Africa.
⁹ Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.
¹⁰ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; CAPRISA-MRC HIV-TB Pathogenesis and Treatment Research Unit, and Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.
¹¹ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; Department of Epidemiology, Columbia University, New York, NY, USA.
¹² Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.

PMID: 32105625
PMCID: PMC7183312
DOI: 10.1016/S2352-3018(19)30402-3

Randomized Controlled Trial

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

Paul K Drain et al. Lancet HIV. 2020 Apr.

. 2020 Apr;7(4):e229-e237.

doi: 10.1016/S2352-3018(19)30402-3. Epub 2020 Feb 24.

Authors

Affiliations

¹ Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA; Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA. Electronic address: pkdrain@uw.edu.
² Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
³ Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.
⁴ Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.
⁵ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
⁶ Prince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, South Africa.
⁷ School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa.
⁸ School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa; Department of Virology, Inkosi Albert Luthuli Central Hospital, Cato Manor, South Africa.
⁹ Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.
¹⁰ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; CAPRISA-MRC HIV-TB Pathogenesis and Treatment Research Unit, and Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.
¹¹ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; Department of Epidemiology, Columbia University, New York, NY, USA.
¹² Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.

PMID: 32105625
PMCID: PMC7183312
DOI: 10.1016/S2352-3018(19)30402-3

Abstract

Background: 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.

Methods: 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.

Findings: 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.

Interpretation: 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.

Funding: National Institute of Allergy and Infectious Diseases.

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Conflict of interest statement

Declaration of interests

All other authors declare no competing interests.

Figures

**Figure 2:**
Kaplan-Meier estimates of time from study enrolment to referral into a community-based ART delivery programme by intervention group and standard-of-care group ART=antiretroviral therapy.

See this image and copyright information in PMC

Comment in

Point-of-care HIV testing can help achieve UNAIDS targets.
Hellard M, Ryan KE, Stoové M. Hellard M, et al. Lancet HIV. 2020 Apr;7(4):e216-e217. doi: 10.1016/S2352-3018(20)30043-6. Epub 2020 Feb 24. Lancet HIV. 2020. PMID: 32105624 No abstract available.
Conceptualising implementation strategies in HIV research.
Mody A, Geng EH. Mody A, et al. Lancet HIV. 2020 Jun;7(6):e382. doi: 10.1016/S2352-3018(20)30142-9. Lancet HIV. 2020. PMID: 32504570 No abstract available.

References

1. Joint United Nations Programme on HIV/AIDS. Miles to go: closing gaps, breaking barriers, righting injustices. 2018. http://www.unaids.org/sites/default/files/media_asset/miles-to-go_en.pdf (accessed May 30, 2019).
1. Joint United Nations Programme on HIV/AIDS. 90–90–90. An ambitious treatment target to help end the AIDS epidemic. 2014. http://www.unaids.org/sites/default/files/media_asset/90–90–90_en.pdf (accessed May 30, 2019).
1. WHO. Interim technical update: technical and operational considerations for implementing HIV viral load testing. July 2014 https://www.who.int/hiv/pub/arv/viral-load-testing-technical-update/en/ (accessed Jan 29, 2020).
1. Grimsrud A, Barnabas RV, Ehrenkranz P, Ford N. Evidence for scale up: the differentiated care research agenda. J Int AIDS Soc 2017; 20: 22024. - PMC - PubMed
1. Habiyambere V, Dongmo Nguimfack B, Vojnov L, et al. Forecasting the global demand for HIV monitoring and diagnostic tests: a 2016–2021 analysis. PLoS One 2018; 13: e0201341. - PMC - PubMed

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

Comment in

References

Publication types

MeSH terms

Substances

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical