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HIV/AIDS
Protocol
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
  1. Jienchi Dorward1,
  2. Nigel Garrett1,2,
  3. Justice Quame-Amaglo3,
  4. Natasha Samsunder1,
  5. Hope Ngobese4,
  6. Noluthando Ngomane4,
  7. Pravikrishnen Moodley5,
  8. Koleka Mlisana6,7,
  9. Torin Schaafsma3,
  10. Deborah Donnell3,
  11. Ruanne Barnabas3,8,9,
  12. Kogieleum Naidoo1,10,
  13. Salim Abdool Karim1,10,11,
  14. Connie Celum3,8,
  15. Paul K Drain3,8,9
  1. 1 Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu–Natal, Durban, KwaZulu–Natal, South Africa
  2. 2 Discipline of Public Health Medicine, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa
  3. 3 Department of Global Health, Schools of Medicine and Public Health, University of Washington, Seattle, Washington, USA
  4. 4 Prince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, KwaZulu-Natal, South Africa
  5. 5 Department of Virology, Inkosi Albert Luthuli Central Hospital, Durban, KwaZulu-Natal, South Africa
  6. 6 School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa
  7. 7 National Health Laboratory Service, Durban, KwaZulu-Natal, South Africa
  8. 8 Department of Medicine, School of Medicine, University of Washington, Seattle, Washington, USA
  9. 9 Department of Epidemiology, School of Public Health, University of Washington, Seattle, USA
  10. 10 MRC-CAPRISA HIV-TB Pathogenesis and Treatment Research Unit, Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa
  11. 11 Department of Epidemiology, Columbia University, New York City, USA
  1. Correspondence to Dr Paul K Drain; pkdrain{at}uw.edu

Abstract

Introduction Achieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shifting to enrolled nurses is non-inferior and cost-effective compared with laboratory-based VL monitoring and standard HIV care.

Methods and analysis The STREAM (Simplifying HIV TREAtment and Monitoring) study is an open-label, non-inferiority, randomised controlled implementation trial. HIV-positive adults, clinically stable at 6 months after ART initiation, will be recruited in a large urban clinic in South Africa. Approximately 396 participants will be randomised 1:1 to receive POC HIV VL monitoring and potential task shifting to enrolled nurses, versus laboratory VL monitoring and standard South African HIV care. Initial clinic follow-up will be 2-monthly in both arms, with VL testing at enrolment, 6 months and 12 months. At 6 months (1 year after ART initiation), stable participants in both arms will qualify for a differentiated care model involving decentralised ART pickup at community-based pharmacies. The primary outcome is retention in care and virological suppression at 12 months from enrolment. Secondary outcomes include time to appropriate entry into the decentralised ART delivery programme, costs per virologically suppressed patient and cost-effectiveness of the intervention compared with standard care. Findings will inform the scale up of VL testing and differentiated care in HIV-endemic resource-limited settings.

Ethics and dissemination Ethical approval has been granted by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC296/16) and University of Washington Institutional Review Board (STUDY00001466). Results will be presented at international conferences and published in academic peer-reviewed journals.

Trial registration NCT03066128; Pre-results.

  • virology
  • international health services

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-017507

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    Footnotes

    • Contributors PD and NG conceived the trial and are the co-principal investigators. PD, NG, JD, JQA, NS, HN, NN, PM, KM, TS, KN, SAK and CC designed the study. PD, NG and JD wrote the study protocol. DD performed sample size calculations and the statistical analysis strategy. RB devised the secondary costing analysis. All authors contributed to the manuscript and consented to final publication.

    • Funding STREAM is funded by the US National Institute for Health (NIH) (AI124719-01) and the University of Washington’s Center for AIDS Research. Cepheid Inc. loaned the GeneXpert instruments for this study at no cost. NIH and Cepheid have no role in study design, manuscript submission or collection, management, analysis or interpretation of study data.

    • Competing interests None declared.

    • Ethics approval University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC296/16) and the University of Washington Institutional Review Board (STUDY00001466).

    • Provenance and peer review Not commissioned; externally peer reviewed.