Implementing a large multisite experimental study in Ukraine
O. Zeziulin1, K. Dumchev1, O. Denisyuk2, S. Dvoriak1, T. Kiryazova1, Y. Sereda1, P. Smyrnov2. 1Ukrainian Institute on Public Health Policy, Ukraine; 2Alliance for Public Health, Ukraine
Background. The research project “Improving Treatment Engagement and Adherence for People Who Inject Drugs in Ukraine” funded by PEPFAR is being implemented since June 2015. The study goal is to evaluate the cascade of HIV care and treatment outcomes among PWID who receive standard HIV prevention services and two strategies designed to improve these outcomes.
Methods. Researchers use prospective quasi-experimental factorial design to test the effectiveness of two strategies, Community Initiated Treatment Intervention (CITI) and Medication Assisted Treatment (MAT) on enrollment in HIV care and in ART. The study will observe the subjects in four study groups receiving standard of care, where one group receives standard of care only, two groups receive either of two study interventions, and one group receives both interventions. The study will detect time of registration at the AIDS Centers, time of prescription and receipt of ART, as well as adherence to ART as study outcomes. Clinical information on ART outcomes (viral load, CD4 count) and MAT outcomes, and sociodemographic statistics along with the data on injection and sexual risk behaviors will be collected as well.
Results. 25 research sites have been established in 16 country regions. Participants’ accrual starting in mid-January 2016 aims to involve 2400 HIV+ PWID, 30% of which are current MAT clients and 50% will receive CITI as an experimental arm in eight regions. Each study site will accrue and retain 150 participants during 1.5-year follow-up period with subsequent assessments on 6, 12 and 18 months.
Conclusion. The study will be completed in 2018 with data analysis and results dissemination.