Abstract
In 2017, the government of Ukraine initiated its ART Optimization Initiative, revising its national antiretroviral therapy (ART) guidelines and embracing Dolutegravir (DTG) as a backbone of first-line ART regimens. A cross-sectional survey of 464 ART patients from 22 large ART clinics was carried out in mid-2019. The survey assessed patient-reported outcomes (PROS) including treatment satisfaction, physical health, mental health, depression, side effects of ART, and adherence. The associations between ART regimen and PROs were assessed using bivariable and multivariable generalized estimating equations (GEE) models. More than half (55.6%) of the patients were satisfied with their current ART regimen. Less than a half (45.3%) considered their physical health as good while only 36.9% rated their mental health as good, 21.3% reported moderate or severe depression, 82.3% reported no side effect in the past 4 weeks, and 44.4% reported not missing ART medication in the past month. In adjusted analysis, patients starting ART with DTG had higher treatment satisfaction compared to people continuing LPV-based regimens (aOR = 0.49, 95% confidence interval: 0.22–0.90). Also in adjusted analyses, unemployment, low income, and history of injection drug use were associated with unfavorable PROs. While the results indicate modestly favorable effects of ART Optimization, there is clearly a need for complementary interventions to improve PROs among disadvantaged ART patients in Ukraine.
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Acknowledgements
The authors thank for all the colleagues at the ART clinics and health facilities in Ukraine for their support. We also thank all the participants for time and sharing their important life stories.
Funding
This publication was made possible by a grant from the Global Fund for AIDS, Tuberculosis and Malaria to the Public Health Center (PHC) of the Ministry of Health of Ukraine, and by grant number U91HA06801 from the U. S. Department of Health and Human Services, Health Resources and Services Administration (HRSA), Office of Global Health to the International Training and Education Center for Health (I-TECH) at the University of Washington. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Ukrainian or US governments.
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NP was responsible for overseeing all aspects of the study. CH and NP were responsible for literature research, data analysis, and manuscript writing. KD was responsible for data management and clinical operations. All other authors provided feedback on data analysis, results interpretation, and manuscript revisions. All authors provided intellectual content to the paper and reviewed and approved the final manuscript.
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The study protocol was approved by the UIPHP Institutional Review Board #1 and the University of Washington Human Subject Division, as an evaluation study with a primary purpose of program improvement.
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Appendix 1
See Table 7.
Appendix 2. Sample size calculation
The sample size was based upon an assumption that the proportion of patients reporting excellent quality of life based on the SF-12 would be higher in the DTG group than in the comparison regimen groups (55% vs. 37% reporting good quality of life). We assumed a two-sided alpha of 0.01 (a conservative level, addressing the fact that we planned to make multiple statistical comparisons) and Zalpha of 2.58, an intraclass correlation coefficient (rho) of 0.05, and 24 clusters (health facilities). This yielded a desired sample size of 168 patients per DTG, EFV, and LPV/r-based regimen comparison groups, or an average of 7 per site per regimen group. This sample yielded a Z-power score of 0.87 representing more than 80% power to detect this difference between each comparison group (e.g. Group 1 vs. Group 2, or Group 1 vs. Group 3). The total sample size for the survey was thus 504 ART patients in total (21 per site × 24 sites). Our sample size was calculated for a primary analysis which did not stratify patients by newly initiating vs. continuing ART patients.
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Hong, C., Puttkammer, N., Riabokon, S. et al. Patient-Reported Treatment Satisfaction and Quality of Life Among People Living with HIV Following the Introduction of Dolutegravir-Based ART Regimens in Ukraine. AIDS Behav 26, 1056–1073 (2022). https://doi.org/10.1007/s10461-021-03461-z
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DOI: https://doi.org/10.1007/s10461-021-03461-z