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Modified Antiretroviral Treatment Access Study (MARTAS): A Randomized Controlled Trial of the Efficacy of a Linkage‐to‐Care Intervention Among HIV-Positive Patients in Ukraine

Abstract

Between October 2015 and March 2018, we conducted the Modified Antiretroviral Treatment Access Study (MARTAS), a nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive. Adult participants from nine urban clinics in three regions of Ukraine were randomized to either MARTAS or standard of care (SOC) using individual, parallel, two-arm design. The main study outcome was linkage-to-care (defined as registration at an HIV clinic) within a 3-month period from enrollment in the study. Intention-to-treat analysis of MARTAS (n = 135) versus SOC (n = 139) showed intervention efficacy in linkage to HIV care (84.4% vs. 33.8%; adjusted RR 2.45; 95% CI 1.72, 3.47; p < 0.001). MARTAS is recommended for implementation in Ukraine and may be helpful in other countries with similar gaps in linkage-to-care. Clinicaltrials.gov registration number: NCT02338024.

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Acknowledgements

We would like to thank Dr. Sherri L. Pals (CDC, Division of Global HIV and Tuberculosis) for advice and comments on statistical aspects. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the funding agencies.

Funding

This project has been supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. CDC under the terms of Grant 3U01GH000752-02S1.

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Correspondence to Oleksandr Neduzhko.

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The authors declare that they have no conflicts of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study protocol and instruments were approved by the institutional human subjects review board at the UIPHP under FWA00015634. The protocol was also reviewed in accordance with the U.S. Centers for Disease Control and Prevention (CDC) human research protection procedures and determined to be research, but CDC investigators did not interact with human subjects or have access to identifiable data or specimens for research purposes. The study was registered in clinicaltrials.gov NCT02338024.

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Written informed consent was obtained from all individual participants included in the study.

Research Involving Human Participants and/or Animals

This article does not contain any studies with animals performed by any of the authors.

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Neduzhko, O., Postnov, O., Sereda, Y. et al. Modified Antiretroviral Treatment Access Study (MARTAS): A Randomized Controlled Trial of the Efficacy of a Linkage‐to‐Care Intervention Among HIV-Positive Patients in Ukraine. AIDS Behav 24, 3142–3154 (2020). https://doi.org/10.1007/s10461-020-02873-7

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Keywords

  • HIV care
  • Nurse case management
  • Linkage-to-care
  • Randomized controlled trial