Piloting a simplified bio-behavioural survey methodology, the BBS-Lite, among people who inject drugs in Georgia.

BACKGROUND: During 2021 and 2023 two simplified Biological and Behavioural Study (BBS-Lite) surveys, and in 2022 one Standard Integrated Biological and Behavioural Study (IBBS), were conducted among people who inject drugs in seven cities in Georgia. From these, an opportunity to compare the implementation of these survey methods and results was able to be gained. METHODS: The two survey types were compared to find points of similarity and difference in their methodologies. The methodologies of the IBBS and BBS-Lite studies shared many characteristics, including the cities where they were implemented, recruitment criteria, sample sizes, and common questionnaire items. All studies were multi-centre cross-sectional involving administration of a face-to-face behavioural questionnaire and collection of biological specimens for testing of HIV, syphilis, hepatitis B virus (HBV), and hepatitis C virus (HCV). The main differences were in the sampling methods. The IBBS utilised respondent-driven sampling (RDS) while participants of the BBS-Lite studies were enrolled through consecutive recruitment at the harm reduction (HR) programme sites and on outreach and through snowball sampling. We compared the results from each study as well as the implementation modalities such as time taken and budgetary requirements, and the complexity of implementation. RESULTS: Considerably less time was required for recruitment, as well as for interviewing, data entry (4 times less) and the analysis for the BSS-Lite studies compared to the IBBS. The BSS-Lite study budgets were at least 2.5 times less than of the IBBS study. The recruited samples were comparable for age distribution, median age at first injection, the last drug injected, sharing of drug injecting equipment or receiving opioid agonist maintenance treatment (OAMT) during the last 12 months. HIV and HCV prevalence were similar including for stratifications by age, client status and city of recruitment. CONCLUSION: Our findings have demonstrated that if implemented on a regular basis, the BBS-Lite can be a complementary solution for systematic data collection, filling surveillance gaps and addressing the challenges that persist in obtaining important data on people who inject drugs (PWID) between IBBS rounds in the country. The methodology is recommended for testing in other settings and in other key populations. In addition, the data collected on a routine base can help the harm reduction (HR) program to better understand the changes in the drug scene and observe new trends in HIV risks and drug injecting behaviours, possible barriers for access to harm reduction, drug treatment, and HIV and/or viral hepatitis testing and treatment services.

Usability and acceptability of oral-based HCV self-testing among key populations: a mixed-methods evaluation in Tbilisi, Georgia.

BACKGROUND: Hepatitis C virus self-testing (HCVST) is an additional approach that may expand access to HCV testing. We conducted a mixed-methods cross-sectional observational study to assess the usability and acceptability of HCVST among people who inject drugs (PWID), men who have sex with men (MSM) and transgender (TG) people in Tbilisi, Georgia. METHODS: The study was conducted from December 2019 to June 2020 among PWID at one harm reduction site and among MSM/TG at one community-based organization. We used a convergent parallel mixed-methods design. Usability was assessed by observing errors made and difficulties faced by participants. Acceptability was assessed using an interviewer-administered semi-structured questionnaire. A subset of participants participated in cognitive and in-depth interviews. RESULTS: A total of 90 PWID, 84 MSM and 6 TG were observed performing HCVST. PWID were older (median age 35 vs 24) and had a lower level of education compared to MSM/TG (27% vs 59%). The proportion of participants who completed all steps successfully without assistance was 60% among PWID and 80% among MSM/TG. The most common error was in sample collection and this was observed more often among PWID than MSM/TG (21% vs 6%; p = 0.002). More PWID requested assistance during HCVST compared to MSM/TG (22% vs 8%; p = 0.011). Acceptability was high in both groups (98% vs 96%; p = 0.407). Inter-reader agreement was 97% among PWID and 99% among MSM/TG. Qualitative data from cognitive (n = 20) and in-depth interviews (n = 20) was consistent with the quantitative data confirming a high usability and acceptability. CONCLUSIONS: HCVST was highly acceptable among key populations in Georgia of relatively high educational level, and most participants performed HCVST correctly. A significant difference in usability was observed among PWID compared to MSM/TG, indicating that PWID may benefit from improved messaging and education as well as options to receive direct assistance when self-testing for HCV.

Feasibility and effectiveness of HCV viraemia testing at harm reduction sites in Georgia: A prospective three-arm study.

BACKGROUND AND AIMS: In 2015, Georgia began a hepatitis C virus (HCV) elimination programme. Although screening programmes have been decentralized for high-risk groups, viraemic testing remains a bottleneck for people who inject drugs. Here, we describe two models of viraemic testing that aimed to address this gap. METHODS: We assigned eight harm reduction sites (HRS) to one of three arms (2,1:1): Xpert HCV viral load testing on-site, blood draw on-site with centralized HCV core antigen testing (HCVcAg), or standard-of-care (SOC) referral with viremia testing performed at treatment centres. RESULTS: 1671 HCV-seropositive participants were enrolled (Xpert, 37.1%; HCVcAg, 29.1%; referral, 33.8%). Participants were predominantly male (95.4%), mean age (IQR) 43 (37, 50) years and 1290 (77.2%) were currently injecting drugs. Significantly higher proportions of participants in the Xpert (100%) and HCVcAg (99.8%) arms received viraemia testing compared with the referral arm (91.3%) (Xpert vs referral, p < 0.0001; HCVcAg vs referral, p < 0.0001). Among viraemic participants, treatment uptake was similar (Xpert, 84.0%; HCVcAg, 79.5%; referral, 88.4%). The time between screening and sample collection for viraemia testing was significantly longer in the referral arm compared with both Xpert and HCVcAg arms (median 1 day compared with 0 days respectively), and the overall time between screening to treatment initiation was longer for the referral arm (median 67 days) compared with both Xpert and HCVcAg arms (median 57 and 50 days respectively). CONCLUSIONS: Point-of-care viraemia testing and blood drawn on-site for HCVcAg testing yielded more HCV-seropositive patients receiving viraemic testing within a shorter timeframe compared with referrals.

Home-based hepatitis C self-testing in people who inject drugs and men who have sex with men in Georgia: a protocol for a randomised controlled trial.

INTRODUCTION: Globally, it is estimated that more than three-quarters of people with chronic hepatitis C virus (HCV) are unaware of their HCV status. HCV self-testing (HCVST) may improve access and uptake of HCV testing particularly among key populations such as people who inject drugs (PWID) and men who have sex with men (MSM) where HCV prevalence and incidence are high and barriers to accessing health services due to stigma and discrimination are common. METHODS AND ANALYSIS: This randomised controlled trial compares an online programme offering oral fluid-based HCVST delivered to the home with referral to standard-of-care HCV testing at HCV testing sites. Eligible participants are adults self-identifying as either MSM or PWID who live in Tbilisi or Batumi, Georgia, and whose current HCV status is unknown. Participants will be recruited through an online platform and randomised to one of three arms for MSM (courier delivery, peer delivery and standard-of-care HCV testing (control)) and two for PWID (peer delivery and standard-of-care HCV testing (control)). Participants in the postal delivery group will receive an HCVST kit delivered by an anonymised courier. Participants in the peer delivery groups will schedule delivery of the HCVST by a peer. Control groups will receive information on how to access standard-of-care testing at a testing site. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who (a) receive a positive result and are made aware of their status, (b) are referred to and complete HCV RNA confirmatory testing, and (c) start treatment. Acceptability, feasibility, and attitudes around HCV testing and cost will also be evaluated. The target sample size is 1250 participants (250 per arm). ETHICS AND DISSEMINATION: Ethical approval has been obtained from the National Centers for Disease Control and Public Health Georgia Institutional Review Board (IRB) (IRB# 2021-049). Study results will be disseminated by presentations at conferences and via peer-reviewed journals. Protocol version 1.1; 14 July 2021. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04961723).

Hepatitis C treatment uptake among patients who have received methadone substitution treatment in the Republic of Georgia.

OBJECTIVES: There is a dearth of research on hepatitis C virus (HCV) treatment uptake among people who inject drugs (PWIDs) and receive methadone substitution treatment (MST) in Eastern Europe and Central Asia countries. This study contributed to addressing that gap. We examined and identified factors that may affect HCV treatment uptake among PWID who received MST in the Republic of Georgia. STUDY DESIGN: The design of the study is retrospective cohort study. METHODS: We conducted HCV care cascade analysis by matching the data from the web-based national hepatitis C program registry (ELIM C) and the MST treatment database between January 1, 2015, and December 31, 2018. Using the World Health Organization's (WHO) Consensus HCV cascade of care (CoC) global instrument, we assessed the progress made toward the country's 2020 and WHO's 2030 hepatitis C elimination targets for the subpopulation of MST patients. RESULTS: Overall, 10,498 individuals have been dispensed methadone during the study period. A total of 6828 MST beneficiaries had HCV screening, of whom 5843 (85.6%) tested positive; 5476 (93.7%) were tested for HCV viremia, and 5275 (96.3%) were confirmed with chronic HCV infection. More than 75% (n = 4000) of HCV-infected MST patients initiated HCV treatment, and 3772 (94.3%) completed the treatment. Of those eligible for sustained virologic response assessment, 71.0% (2641/3715) were evaluated, and the reported cure rate was 96.1% (2537). The study found the odds of patients starting HCV treatment differed by the type of facility they were screened at and whether they were registered as PWID at the screening sites. The patients screened at centers with integrated HCV treatment services had higher treatment uptake rates than those screened at other centers. CONCLUSIONS: As the cumulative HCV treatment uptake and cure rates among MST patients with HCV infection are high (75.8% and 96.1%, respectively), the MST patients might become the first microelimination target population in which hepatitis C elimination will be achieved in Georgia. The study found the type of screening facility and whether MST patients registered themselves as PWID or not had significant effects on MST patients starting HCV treatment. At the same time, the study did not find gender and age to be significant predictors of MST patients starting HCV treatment. MST patients used different types of health facilities to get screened for HIV. Many of them did not register themselves as PWID when screened for HIV. The existence of only a few harm reduction sites with integrated HCV treatment services, a high level of stigma, and the criminalization of drug use might have incentivized MST patients to self-navigate across the HCV care continuum with the rest of the population. The implementation of focused, harm reduction, integrated HCV treatment with good peer and professional adherence support at treatment sites could help reach the hepatitis C elimination goals among MST patients.

Interim effect evaluation of the hepatitis C elimination programme in Georgia: a modelling study.

BACKGROUND: Georgia has a high prevalence of hepatitis C, with 5·4% of adults chronically infected. On April 28, 2015, Georgia launched a national programme to eliminate hepatitis C by 2020 (90% reduction in prevalence) through scaled-up treatment and prevention interventions. We evaluated the interim effect of the programme and feasibility of achieving the elimination goal. METHODS: We developed a transmission model to capture the hepatitis C epidemic in Georgia, calibrated to data from biobehavioural surveys of people who inject drugs (PWID; 1998-2015) and a national survey (2015). We projected the effect of the administration of direct-acting antiviral treatments until Feb 28, 2019, and the effect of continuing current treatment rates until the end of 2020. Effect was estimated in terms of the relative decrease in hepatitis C incidence, prevalence, and mortality relative to 2015 and of the deaths and infections averted compared with a counterfactual of no treatment over the study period. We also estimated treatment rates needed to reach Georgia's elimination target. FINDINGS: From May 1, 2015, to Feb 28, 2019, 54 313 patients were treated, with approximately 1000 patients treated per month since mid 2017. Compared with 2015, our model projects that these treatments have reduced the prevalence of adult chronic hepatitis C by a median 37% (95% credible interval 30-44), the incidence of chronic hepatitis C by 37% (29-44), and chronic hepatitis C mortality by 14% (3-30) and have prevented 3516 (1842-6250) new infections and averted 252 (134-389) deaths related to chronic hepatitis C. Continuing treatment of 1000 patients per month is predicted to reduce prevalence by 51% (42-61) and incidence by 51% (40-62), by the end of 2020. To reach a 90% reduction by 2020, treatment rates must increase to 4144 (2963-5322) patients initiating treatment per month. INTERPRETATION: Georgia's hepatitis C elimination programme has achieved substantial treatment scale-up, which has reduced the burden of chronic hepatitis C. However, the country is unlikely to meet its 2020 elimination target unless treatment scales up considerably. FUNDING: CDC Foundation, National Institute for Health Research, National Institutes of Health.

Progress in Testing for and Treatment of Hepatitis C Virus Infection Among Persons Who Inject Drugs - Georgia, 2018.

In April 2015, the country of Georgia, with a high prevalence of hepatitis C virus (HCV) infection (5.4% of the adult population, approximately 150,000 persons), embarked on the world's first national elimination program (1,2). Nearly 40% of these infections are attributed to injection drug use, and an estimated 2% of the adult population currently inject drugs, among the highest prevalence of injection drug use in the world (3,4). Since 2006, needle and syringe programs (NSPs) have been offering HCV antibody testing to persons who inject drugs and, since 2015, referring clients with positive test results to the national treatment program. This report summarizes the results of these efforts. Following implementation of the elimination program, the number of HCV antibody tests conducted at NSPs increased from an average of 3,638 per year during 2006-2014 to an average of 21,551 during 2015-2018. In 2017, to enable tracking of clinical outcomes among persons who inject drugs, NSPs began encouraging clients to voluntarily provide their national identification number (NIN), which all citizens must use to access health care treatment services. During 2017-2018, a total of 2,780 NSP clients with positive test results for HCV antibody were identified in the treatment database by their NIN. Of 494 who completed treatment and were tested for HCV RNA ≥12 weeks after completing treatment, 482 (97.6%) were cured of HCV infection. Following the launch of the elimination program, Georgia has made much progress in hepatitis C screening among persons who inject drugs; recent data demonstrate high cure rates achieved in this population. Testing at NSPs is an effective strategy for identifying persons with HCV infection. Tracking clients referred from NSPs through treatment completion allows for monitoring the effectiveness of linkage to care and treatment outcomes in this population at high risk, a key to achieving hepatitis C elimination in Georgia. The program in Georgia might serve as a model for other countries.

Prevalence of hepatitis C, HIV, and risk behaviors for blood-borne infections: a population-based survey of the adult population of T'bilisi, Republic of Georgia.

Injection drug use and associated hepatitis C virus (HCV) and HIV infections are on the rise in Russia and the republics of the former Soviet Union. While small targeted studies have found widespread drug use and disease among at-risk populations, there have been few attempts to comprehensively evaluate the extent of these epidemics in general post-Soviet societies. We conducted a two-stage cluster randomized survey of the entire adult population of T'bilisi, Republic of Georgia and assessed the burden of HCV, HIV, and risk behaviors for blood-borne infections in 2,000 study participants. Of the 2,000 surveyed individuals, 162 (8.1%) had injected illicit drugs during their lifetimes. Of the individuals who had injected illicit drugs, 138 (85.2%) reported sharing needles with injection partners. HCV was found in 134 (6.7%) of the total surveyed population, but in 114 (70.4%) of those who had injected illicit drugs. We found HIV in only three (0.2%) individuals, all of whom had injected illicit drugs. Injection drug use and high-risk injection practices are very common in Georgia and may be harbingers of a large burden of HCV-associated liver diseases and a potentially serious HIV epidemic in the years to come.