Unitaid – Global Health Campus
This study aims to generate evidence on best practice approaches for implementing LDSS/N distribution programs that enhance acceptability and sustain high levels of LDSS/N uptake (effectiveness) among people who inject drugs. Data generated will also be used in mathematical modelling to estimate the impact and cost-effectiveness of scaling up LDSS/N for people who inject drugs at a country-level. This evidence will inform national and WHO guidance and recommendations on LDSS/N distribution in Ukraine.
1. Explore community values and preferences for LDSS/N in the context of other harm reduction supplies available to PWID.
2. Identify barriers and facilitators to access and uptake of LDSS/N among PWID.
3. Design and implement an LDSS/N distribution program informed by community values and preferences.
4. Evaluate the feasibility and effectiveness of this LDSS/N distribution program on increasing LDSS uptake (primary outcome) by:
a. Measuring patterns of LDSS/N uptake;
b. Identifying the enablers and challenges affecting the supply chain for LDSS/N;
c. Documenting the legal, social and regulatory enablers and challenges affecting the successful introduction and maintenance of LDSS/N distribution;
d. Evaluating demand creation approaches.
5. Estimate the effectiveness of this LDSS/N distribution program by measuring the difference in BBV (HCV/HIV) incidence between those who exclusively use LDSS/N and those who do not (secondary outcome).
6. Model the potential public health impact (HIV and HCV infections averted) and cost-effectiveness of LDSS/N distribution for PWID within harm reduction settings.
National Institute of Health
The goal of this study is to create the foundation for: 1) a follow-up cohort study of PLWH, and 2) inform patient management practices to reduce NCD-associated morbidity and mortality among Ukrainian PLWH.
1. Characterize the pilot study sample using simple demographic variables (age, sex at birth, gender, etc.) as well as HIV and other infectious disease (ID) variables including history of AIDS, HIV viral load, current and nadir CD4+ counts and history of tuberculosis and HCV.
2. Assess physical performance, daily functioning and physical activity using the WHO International Classification of Functioning, Disability and Health; components of the Short Physical Performance Battery (4m walk, grip strength, and repeated chair stands); and WHO Global Physical Activity Questionnaire.
3. Measure NCDs including overweight, obesity, hypertension, T2D, and CVD; and mental health NCDs including depression, PTSD alcohol use disorder (AUD), and substance use disorder (SUD)..
4. Calculate cross-sectional associations of physical function, performance and activity with aging-related NCD outcomes, individually and in combination, and with consideration for HIV/ID factors, self-reported sociodemographic factors and medical history.
Fogarty International Center
To develop implementation strategies that address gaps in the HIV cascade and substance use treatment system in Ukraine in the context of humanitarian crisis, through US-based individual research training and research training capacity building at the School of Public Health at NaUKMA.
- Provide HIV Research Fellowships to 6 students.
- Ensure 2 semesters in person training (epi, biostats, research skills) and semester internship at New York State Department of Health AIDS Institute.
- Provide advanced degree training (MS) in epidemiology for three early career investigators.
- Provide three scientific writing workshops to 85 participants.
- Build research training capacity at SPH NaUKMA; ensure further development of HIV research certificate course and mentor in-country research training projects.
National Institute of Health
The aim of this project is to create Peer-Navigation Intervention and pilot test it to (re-)engage PWID in SUD care and HIV care.
1) pilot a peer education, social network intervention for MAT uptake and retention and enhancing HIV medical care and ART adherence among those social network members living with HIV who use drugs;
2) quantitatively and qualitatively assess barriers to MAT and ART uptake and adherence from the perspectives of peer educators and their network members and identify effective strategies and approaches used by peer educators to promote MAT and ART among their network members;
3) determine the potential effect size, effectiveness, and feasibility of this intervention for HIV prevention (based on seroconversions and reduction in HIV risk behaviors) as well as improvement in HIV-related health outcomes among PLWH PWID for implementing an RCT of a peer education and social network-based intervention to increase MAT uptake and retention among PWID.
NIDA/Johns Hopkins University
The aim of the study is to adapt and evaluate a data-to-care case management intervention for people who inject drugs and live with HIV.
1. To adapt a D2C implementation strategy for Ukraine.
2. To study preliminary effectiveness of a D2C strategy versus standard of care.
3. 3a: To assess the feasibility, acceptability, and implementation-related processes and outcomes of the D2C strategy.
3b: Determine the cost of the D2C strategy.
The Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB
Evaluate feasibility and effectiveness of a simplified HCV care and treatment model integrated into OAT programs in Ukraine.
- To develop SHIM and demonstrate its feasibility.
- Using a multi-level implementation science framework, to examine the client, clinician and organizational factors that contribute to SHIM adoption and clinical outcomes.
- To evaluate the effectiveness of SHIM in improving the HCV treatment cascade outcomes using a cluster-randomized three-arm trial design in 480 HCV-infected patients at 12 OAT clinics (4 clinics per arm) randomized to standard of care (N=160) versus SHIM with (N=160) or without (N=160) ECHO facilitation.
National Institute on Drug Abuse (NIDA)
The aim of this project is to study the effectiveness of the modified SBIRT, where instead of offsite psychiatric referral, depression is treated onsite using SSRIs. Also, we will use ECHO (Extension for Community Healthcare Outcomes), a collaborative learning process, to facilitate mSBIRT activities and reinforce integration of COD services in OAT clinics.To enhance ECHO implementation, evidence-based pay-forperformance (P4P) intervention, aligned with Ukraine’s health reform, will be added to determine if incremental benefits are derived from this EBP, in an effort to strengthen and support ongoing healthcare reform efforts in Ukraine.
1. To compare both service-level (screening and brief intervention adoption and penetration) and patient-level (SSRI initiation, OAT drop-out and psychiatric quality of life) outcomes in 1,350 patients with opioid use disorders receiving OAT from 4 regions (clusters) and 12 clinical settings using a randomized, cluster-controlled design over 24 months. Before site randomization, all OAT clients at each participating site will have baseline assessments followed by site randomization to receive standard of care (N=450) versus integrated care using ECHO-COD facilitation with (N=450) or without (N=450) P4P incentives;
2. Using a multi-level implementation science framework, to examine the contribution of client, clinician and organizational factors that contribute to the primary and secondary outcomes;
3. To conduct a cost-effectiveness analysis (CEA) of integrating COD services into OAT clinics, with or without P4P, compared to a control group of OAT sites.
Machavariani E., Bromberg D., Dumchev K., Dvoriak S., Zeziulin O., Morozova O., Esserman D., Pykalo I., Saichuk N., Ivasiy R., Haddad M., Altice F. Design, implementation and preliminary results of a type-2 hybrid cluster-randomized trial of integrating screening and treatment for major depressive disorder into specialty clinics providing opioid agonist therapies in Ukraine. Contemporary Clinical Trials, 2023 May 30 (EN)