Low daily oral PrEP adherence and low validity of self-report in a randomized trial among PWID in Ukraine.

BACKGROUND: The efficacy of daily oral pre-exposure prophylaxis (PrEP) in preventing HIV transmission among people who inject drugs (PWID) was demonstrated over a decade ago. However, only a few studies among PWID have since measured PrEP adherence using laboratory markers. METHODS: In this trial, we randomized recently injecting PWID in Kyiv, Ukraine, to receive daily oral TDF/FTC with or without SMS reminders. Enrollment and PrEP initiation took place at an HIV clinic. Subsequent visits at months 1, 3, and 6 were conducted at a community harm reduction center and included a structured interview, adherence counseling, PrEP dispensing, and dried blood spot collection. PrEP adherence was assessed using standard self-reported measures and TDF/FTC biomarkers. RESULTS: A total of 199 PWID (99 SMS, 100 No-SMS) were enrolled, of whom 24 % were women, with a median age of 37. At month 6, 79.4 % (158/199) of participants were retained, with 84 % (133/158) reporting opioid injection and 20 % (31/158) reporting stimulant injection in the past 30 days. 77 % (122/158) reported taking >95 % of PrEP doses in the past month, and 87 % reported taking the last dose within 2 days. Tenofovir diphosphate was detected in 17 % (28/158) of participants, and emtricitabine triphosphate was detected in 25 % (40/158). Only 3 % (5/158) had metabolite levels indicative of consistent PrEP uptake at 4+ doses per week. There was no association between the SMS intervention and TDF/FTC metabolite detection. CONCLUSION: Adherence to daily oral PrEP among actively injecting PWID, without daily supervision or incentives, was extremely low, despite supportive counseling and SMS reminders. We also observed a high rate of discordance between self-report and classification by a validated biomarker of adherence. Given the scarcity of evidence and emerging data suggesting low oral PrEP adherence among PWID, additional implementation studies with TDF/FTC biomarkers are needed to study whether a sufficient level of adherence to daily PrEP is attainable among PWID, especially as long-acting injectable PrEP offers a promising alternative.

Community-based HIV prevention services for transgender people in Ukraine: current situation and potential for improvement.

BACKGROUND: Community-based HIV-prevention services are a key approach to prevent HIV transmission among key population representatives. Transgender people have multiple specific needs and it is crucial to use prevention approaches that effectively respond to those needs and facilitate barriers on the way to use HIV prevention and related services. This study is aimed to explore the current state of community-based HIV prevention services among transgender people in Ukraine, its limitations and potential for improvement based on the experience and perceptions of transgender people, physicians, and community social workers providing services to transgender people. METHODS: Semi-structured in-depth interviews were conducted among physicians providing services to transgender people (N = 10), community social workers (N = 6), and transgender people (N = 30). The objectives of the interviews were to explore: the relevance of the community-based HIV prevention services to the needs of transgender people; the key components of the most preferred ("ideal") HIV-prevention package for transgender people; ways to optimize the existing HIV prevention package for transgender people including enrollment and retention. Systematically collected data were analyzed and coded into the main domains, thematic categories and subcategories using thematic analysis. RESULTS: The current HIV prevention programs were well-evaluated by the majority of respondents. Gender-affirming care was found to be the key need of transgender people. Integration of HIV prevention services and gender-affirming care was perceived as the main way to address the needs of transgender people. Internet-based and peer word-of-mouth recruitment may improve enrollment in services. Optimization of existing HIV prevention package may include: psychological counseling, referral and navigation to medical services, legal services, pre- and post-exposure prevention, dissemination of tube lubricants, femidoms and latex wipes, use of oral fluid test systems for HIV self-testing. CONCLUSIONS: The findings of this study suggest potential solutions to improve community-based HIV prevention services for transgender people by introducing a transgender people -oriented package, which integrates gender transition, HIV prevention and other services. Provision of prevention services based on assessed risk and referral/navigation to related services are the key options for optimization of the existing HIV prevention package. TRIAL REGISTRATION: Not applicable.

Modelling the impact and cost-effectiveness of non-governmental organizations on HIV and HCV transmission among people who inject drugs in Ukraine.

INTRODUCTION: People who inject drugs (PWID) in Ukraine have high prevalences of HIV and hepatitis C virus (HCV). Non-governmental organizations (NGOs) provide PWID with needles/syringes, condoms, HIV/HCV testing and linkage to opioid agonist treatment (OAT) and antiretroviral therapy (ART). We estimated their impact and cost-effectiveness among PWID. METHODS: A dynamic HIV and HCV transmission model among PWID was calibrated using data from four national PWID surveys (2011-2017). The model assumed 37-49% coverage of NGOs among community PWID, with NGO contact reducing injecting risk and increasing condom use and recruitment onto OAT and ART. We estimated the historic (1997-2021) and future (2022-2030, compared to no NGO activities from 2022) impact of NGOs in terms of the proportion of HIV/HCV infections averted and changes in HIV/HCV incidence. We estimated the future impact of scaling-up NGOs to 80% coverage with/without scale-up in OAT (5-20%) and ART (64-81%). We estimated the cost per disability-adjusted life-year (DALY) averted of current NGO provision over 2022-2041 compared to NGO activities stopping over 2022-2026, but restarting after that till 2041. We assumed average unit costs of US$80-90 per person-year of NGO contact for PWID. RESULTS: With existing coverage levels of NGOs, the model projects that NGOs have averted 20.0% (95% credibility interval: 13.3-26.1) and 9.6% (5.1-14.1) of new HIV and HCV infections among PWID over 1997-2021, respectively, and will avert 31.8% (19.6-39.9) and 13.7% (7.5-18.1) of HIV and HCV infections over 2022-2030. With NGO scale-up, HIV and HCV incidence will decrease by 54.2% (43.3-63.8) and 30.2% (20.5-36.2) over 2022-2030, or 86.7% (82.9-89.3) and 39.8% (31.4-44.8) if OAT and ART are also scaled-up. Without NGOs, HIV and HCV incidence will increase by 51.6% (23.6-76.3) and 13.4% (4.8-21.9) over 2022-2030. Current NGO provision over 2022-2026 will avert 102,736 (77,611-137,512) DALYs when tracked until 2041 (discounted 3% annually), and cost US$912 (702-1222) per DALY averted; cost-effective at a willingness-to-pay threshold of US$1548/DALY averted (0.5xGDP). CONCLUSIONS: NGO activities have a crucial preventative impact among PWID in Ukraine which should be scaled-up to help achieve HIV and HCV elimination. Disruptions could have a substantial detrimental impact.

Impact and cost-effectiveness of non-governmental organizations on the HIV epidemic in Ukraine among MSM.

OBJECTIVE: Non-governmental organizations (NGOs) in Ukraine have provided HIV testing, treatment, and condom distribution for MSM. HIV prevalence among MSM in Ukraine is 5.6%. We estimated the impact and cost-effectiveness of MSM-targeted NGO activities in Ukraine. DESIGN: A mathematical model of HIV transmission among MSM was calibrated to data from Ukraine (2011-2018). METHODS: The model, designed before the 2022 Russian invasion of Ukraine, evaluated the impact of 2018 status quo coverage levels of 28% of MSM being NGO clients over 2016-2020 and 2021-2030 compared with no NGO activities over these time periods. Impact was measured in HIV incidence and infections averted. We compared the costs and disability adjusted life years (DALYs) for the status quo and a counterfactual scenario (no NGOs 2016-2020, but with NGOs thereafter) until 2030 to estimate the mean incremental cost-effectiveness ratio (cost per DALY averted). RESULTS: Without NGO activity over 2016-2020, the HIV incidence in 2021 would have been 44% (95% credibility interval: 36-59%) higher than with status quo levels of NGO activity, with 25% (21-30%) more incident infections occurring over 2016-2020. Continuing with status quo NGO coverage levels will decrease HIV incidence by 41% over 2021-2030, whereas it will increase by 79% (60-120%) with no NGOs over this period and 37% (30-51%) more HIV infections will occur. Compared with if NGO activities had ceased over 2016-2020 (but continued thereafter), the status quo scenario averts 14 918 DALYs over 2016-2030 with a mean incremental cost-effectiveness ratio of US$600.15 per DALY averted. CONCLUSION: MSM-targeted NGOs in Ukraine have prevented considerable HIV infections and are highly cost-effective compared with a willingness-to-pay threshold of 50% of Ukraine's 2018 GDP (US$1548).

Has resourcing of non-governmental harm-reduction organizations in Ukraine improved HIV prevention and treatment outcomes for people who inject drugs? Findings from multiple bio-behavioural surveys.

INTRODUCTION: People who inject drugs (PWID) in Ukraine have high prevalences of HIV and hepatitis C (HCV). Since the turn of the century, various organizations have funded non-governmental organizations (NGOs) in Ukraine to provide PWID with needles and syringes, condoms, HIV and HCV testing, and improve linkage to opioid agonist therapy (OAT) and HIV treatment. We investigated whether contact with these NGOs was associated with improved HIV prevention and treatment outcomes among PWID. METHODS: Five rounds of respondent-driven sampled integrated bio-behavioural survey data (2009 [N = 3962], 2011 [N = 9069], 2013 [N = 9502], 2015 [N = 9405], and 2017 [N = 10076]) among PWID in Ukraine (including HIV/HCV testing and questionnaires) were analysed using mixed-effect logistic regression models (mixed-effects: city, year). These regression models assessed associations between being an NGO client and various behavioural, OAT, HIV testing and HIV treatment outcomes, adjusting for demographic characteristics (age, gender, lifetime imprisonment, registration in a drug abuse clinic, education level). We also assessed associations between being an NGO client and being HIV positive or HCV positive, likewise adjusting for demographic characteristics (as above). RESULTS: NGO clients were more likely to have received HIV testing ever (adjusted odds ratio [aOR] 5.37, 95% confidence interval [95% CI]: 4.97 to 5.80) or in the last year (aOR 3.37, 95% CI: 3.20 to 3.54), to have used condoms at last sexual intercourse (aOR 1.37, 95% CI: 1.30 to 1.44) and sterile needles at last injection (aOR 1.37, 95% CI: 1.20 to 1.56), to be currently (aOR 4.19, 95% CI: 3.48 to 5.05) or ever (aOR 2.52, 95% CI: 2.32 to 2.74) on OAT, and to have received syringes (aOR 109.89, 95% CI: 99.26 to 121.66) or condoms (aOR 54.39, 95% CI: 50.17 to 58.96) in the last year. PWID who were HIV positive (aOR 1.40, 95% CI: 1.33 to 1.48) or HCV positive (aOR 1.57, 95% CI: 1.49 to 1.65) were more likely to have contact with NGOs, with HIV positive PWID in contact with NGOs being more likely to be registered at AIDS centres (aOR 2.34, 95% CI: 1.88 to 2.92) and to be on antiretroviral therapy (aOR 1.60, 95% CI: 1.40 to 1.83). CONCLUSIONS: Contact with PWID targeted NGOs in Ukraine is associated with consistently better preventive, HIV testing and HIV treatment outcomes, suggesting a beneficial impact of harm reduction NGO programming.

Operationalizing the HIV prevention cascade for PWID using the integrated bio-behavioural survey data from Ukraine.

INTRODUCTION: People who inject drugs (PWID) remain at high risk of HIV in many countries. The HIV prevention cascades have been proposed to replicate the success of the treatment cascades and reinvigorate the prevention programmes through improved monitoring, planning and delivery. We adapted the cascade framework to the PWID context in Ukraine, assessed gaps and analysed factors associated with achieving "access" and "effective use" outcomes. METHODS: Self-reported data on the use of prevention services and risk behaviours from the 2017 integrated bio-behavioural survey among PWID in Ukraine were used to construct cascades for needle/syringe and condom programmes (NSP and CP). Socio-demographic and behavioural variables were evaluated as potential correlates of cascade outcomes. RESULTS: The NSP cascade analysis included 7815 HIV-negative PWID. Motivation to use clean syringes was not assessed and assumed at 100%. Access to clean syringes through NSP in the past 12 months was reported by 2789 participants (35.7%). Effective use of syringes (no sharing in the past 30 days) was reported by 7405 participants (94.8%). NSP access was higher among women, individuals older than 44, and mixed drug users; while effective use was reported more frequently by men and opioid users, with no difference by age. The CP cascade analysis included 6606 (85%) of the HIV-negative PWID who had sex in the past three months. Of those, 2282 (34.5%) received condoms, and 1708 (25.9%) reported consistent use with all partners in the past three months. Older PWID and mixed-drug users accessed condoms more frequently; whereas younger subgroups and opioid users used them more consistently. CONCLUSIONS: Overall, the cascade framework was useful to describe the status of HIV prevention among PWID in Ukraine and to identify areas for improvement in the programming and evaluation of HIV prevention. Access to needle/syringe and condom programmes was substantially below the recommended levels. Effective use of clean syringes was reported by a vast majority of PWID, although likely affected by self-report bias; whereas consistent condom use was infrequent. Socio-demographic and behavioural variables showed significant associations in NSP and CP cascade analyses, with little consistency between the access and effective use outcomes.

Trends in HIV prevalence among people injecting drugs, men having sex with men, and female sex workers in Ukraine.

Once recognized as the most severe in Europe, the HIV epidemic in Ukraine is concentrated among people who inject drugs, men who have sex with men, and female sex workers. Integrated biobehavioral surveys, as a part of the second generation surveillance, are used to monitor HIV infection trends in key populations since 2002. The present paper is focused on the analysis of HIV prevalence trends in four nationally representative rounds of integrated biobehavioral surveys from 2008/9, 2011, 2013, and 2015 in people who inject drugs, men who have sex with men, and female sex workers. Between 2008/9 and 2015, the HIV prevalence has decreased significantly in people who inject drugs (24.2 to 22.0%) and female sex workers (13.6 to 6.3%), while the change in men who have sex with men was not significant (8.5 to 7.8%). There was a significant increase in people who inject drugs and men who have sex with men between 2013 and 2015. In subgroups younger than 25 years, prevalence increased more than twofold in men who have sex with men (1.9 to 4.3%), with no changes in people who inject drugs and female sex workers. The observed decline in prevalence, especially in young subgroups, may result from the effect of extensive prevention efforts on drug injection-related transmission. Recent increase in young men who have sex with men may be a sign of a new wave of the epidemic in this group.

Developing and implementing national health identifiers in resource limited countries: why, what, who, when and how?

Many resource-limited countries are scaling up health services and health-information systems (HISs). The HIV Cascade framework aims to link treatment services and programs to improve outcomes and impact. It has been adapted to HIV prevention services, other infectious and non-communicable diseases, and programs for specific populations. Where successful, it links the use of health services by individuals across different disease categories, time and space. This allows for the development of longitudinal health records for individuals and de-identified individual level information is used to monitor and evaluate the use, cost, outcome and impact of health services. Contemporary digital technology enables countries to develop and implement integrated HIS to support person centred services, a major aim of the Sustainable Development Goals. The key to link the diverse sources of information together is a national health identifier (NHID). In a country with robust civil protections, this should be given at birth, be unique to the individual, linked to vital registration services and recorded every time that an individual uses health services anywhere in the country: it is more than just a number as it is part of a wider system. Many countries would benefit from practical guidance on developing and implementing NHIDs. Organizations such as ASTM and ISO, describe the technical requirements for the NHID system, but few countries have received little practical guidance. A WHO/UNAIDS stake-holders workshop was held in Geneva, Switzerland in July 2016, to provide a 'road map' for countries and included policy-makers, information and healthcare professionals, and members of civil society. As part of any NHID system, countries need to strengthen and secure the protection of personal health information. While often the technology is available, the solution is not just technical. It requires political will and collaboration among all stakeholders to be successful.

Patterns of harm reduction service utilization and HIV incidence among people who inject drugs in Ukraine: A two-part latent profile analysis.

BACKGROUND: Program utilization patterns are described within a large network of harm reduction service providers in Ukraine. The relationship between utilization patterns and HIV incidence is determined among people who inject drugs (PWID) controlling for oblast-level HIV incidence and treatment/syringe coverage. METHODS: Data were extracted from the network's monitoring and evaluation database (January 2011-September 2014, n=327,758 clients). Latent profile analysis was used to determine harm reduction utilization patterns using the number of HIV tests received annually and the number of condoms, syringes, and services (i.e., information and counseling sessions) received monthly over a year. Cox proportional hazards regression determined the relations between HIV seroconversion and utilization class membership. RESULTS: In the final 4-class model, class 1 (34.0% of clients) received 0.1 HIV tests, 1.3 syringes, 0.6 condom and minimal counseling and information sessions per month; class 2 (33.6%) received 8.6 syringes, 3.2 condoms, and 0.5 HIV tests and counseling and information sessions; class 3 (19.1%) received 1 HIV test, 11.9 syringes, 4.3 condoms, and 0.7 information and counseling sessions; class 4 (13.3%) received 1 HIV test, 26.1 syringes, 10.3 condoms, and 1.8 information and 1.9 counseling sessions. Class 4 clients had significantly decreased risk for HIV seroconversion as compared to those in class 1 after controlling for oblast-level characteristics. CONCLUSION: Injection drug use continues to be a major mode of HIV transmission in Ukraine, making evaluation of harm reduction efforts in reducing HIV incidence among PWID critical. These analyses suggest that receiving more syringes and condoms decreased risk of HIV. Scaling up HIV testing and harm reduction services is warranted.

Evolution of Monitoring and Evaluation of AIDS Response in Ukraine: Laying the Groundwork for Evidence-Based Health Care.

Once facing the most severe HIV epidemic in Eastern Europe, Ukraine has built an elaborate Monitoring and Evaluation (M&E) system to track the response to AIDS. This system was developed using recommendations and input from multiple international expert organizations and donors and, at the current stage, serves as a best practice model in many areas. The present paper aims to provide a comprehensive overview of the evolution of the M&E system in Ukraine since its inception. Notable achievements and challenges are described and illustrated by epidemiological data and the recommendations for future development are discussed. Unique experiences and advances in M&E in Ukraine may be useful to other countries facing similar epidemiological, structural or methodological issues.