Despite the availability of curative treatments, hepatitis C diagnosis and treatment coverage is suboptimal globally with few countries on track to achieve the WHO’s 2030 elimination targets. In 2022, an estimated 50 million people were living with hepatitis C, with 1 million new infections annually. Most people living with hepatitis C reside in low- and middle-income countries, and people who inject drugs are disproportionately affected by hepatitis C.

Continuing simplification of diagnostic pathways and treatment care models is required to improve linkage to care and reduce costs associated with hepatitis C treatment and cure.

This study is a multi-country non-randomised, quasi-experimental, prospective comparative two-arm trial. It aims to assess the feasibility of implementation, retention in hepatitis C care and achievement of cure and cost-effectiveness outcomes, comparing two simplified hepatitis C testing and treatment pathways.

Arm 1 is a standard simplified test and treat model of care following global guidance, and arm 2 is an innovative rapid, same-day treatment initiation model of care using a presumptive treatment approach based on shortened read-time of the point-of-care OraQuick hepatitis C antibody test result. Secondary outcomes include assessing the accuracy of the OraQuick hepatitis C antibody test in predicting viraemia and the acceptability of each pathway.

This study will be implemented in Armenia, Georgia and Tanzania. Treatment-naïve people who inject drugs aged over 18 years in each country will be eligible for enrolment.

Recruitment commenced in October 2024 in Armenia, June 2025 in Georgia and August 2025 in Tanzania and is anticipated to close by December 2026.

This trial has been reviewed by WHO Ethics Review Committee (ERC), Alfred Hospital Ethics Committee (Australia) and local country ERCs. Alongside journal publications and conferences, the results from this study will be disseminated through summary reports and workshops with key stakeholders and with communities of people affected by HCV through relevant organisations/networks, including the global Community Advisory Board (CAB). The study results will inform national scale-up of simplified care models and inform potential pathways for further simplification of care models, including the potential for one-step diagnostic pathways and same-day treatment in particular scenarios for the three study countries, and other low- and middle-income countries globally.

NCT06159504.

To assess whether transgender women who have sex with men (TGWSM) sampled in men who have sex with men (MSM) biobehavioural surveys in Ukraine experience different levels of sexual risk, stigma, HIV prevalence and engagement in the HIV care than cisgender MSM (CMSM).

Analysis of secondary data from three population-level cross-sectional surveys.

The analysis was conducted on data from three rounds of integrated biobehavioural surveys of MSM in 27 cities of Ukraine from 2013 to 2018.

Data from n=18 621 MSM with n=18 102 CMSM and n=503 TGWSM.

The primary outcomes were differences in sexual risk behaviours, HIV testing and treatment uptake, and the secondary outcomes were differences in lifetime experiences of stigma, coercive sex and physical assault (in the 2018 survey only) between CMSM and TGWSM.

Compared with CMSM, TGWSM were more likely to be clients of non-governmental organisations (adjusted OR, aOR: 1.39, 95% CI 1.15 to 1.67), engage in commercial sex (last month; aOR: 1.28, 95% CI 1.01 to 1.61), have group sex (aOR: 1.31, 95% CI 1.06 to 1.61), more long-term sex partners (last month; adjusted incidence rate ratio: 1.14, 95% CI 1.03 to 1.27), history of imprisonment (aOR: 1.51, 95% CI 1.00 to 2.31) and engage in chemsex (last month, aOR: 1.58, 95% CI 1.12 to 2.23). We found no difference in HIV prevalence (5.17% in TGWSM vs 5.43% in CMSM, p=0.065). In 2018, more TGWSM reported lifetime experience of stigma from family and friends (aOR: 3.58, 95% CI 2.54 to 5.04), general social stigma (aOR: 3.13, 95% CI 2.22 to 4.41), anticipated healthcare stigma (aOR: 3.63, 95% CI 2.53 to 5.16), physical assault (aOR: 2.73, 95% CI 1.85 to 4.03) and coercive sex (aOR: 3.01, 95% CI 1.99 to 4.55) than CMSM.

TGWSM in Ukraine may be at increased risk of HIV acquisition compared to CMSM due to many factors including elevated levels of stigma and violence. Services specifically tailored for transgender people are needed to help reduce these high-risk behaviours.