Implementing a Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries: a Process and Outcome Evaluation

What this Trial Is About

The trial investigates the implementation and evaluation of a distribution program for low dead-space syringes and needles (LDSS/N) among people who inject drugs across multiple low- and middle-income countries. The study aims to provide evidence on how best to run LDSS/N distribution programs to improve acceptability and maintain high usage levels, potentially reducing transmission of blood borne viruses such as HIV and hepatitis C. This observational study involves participants who access needle and syringe programs (NSPs) at existing sites. The study includes three phases: initially, focus group discussions (FGDs) will gather participant feedback on various LDSS/N products to guide selection for pilot distribution. Then, over a 6-week pilot period, participants will use the selected LDSS/N products alongside usual NSP services. Finally, a scaled-up distribution of selected LDSS/N products will be offered at study sites, with routine program data collection and a concurrent observational cohort study running alongside. Participants in the cohort will undergo HIV and HCV testing and complete surveys at baseline, 6, 12, and 18 months. Participants will be engaged through multiple FGDs to discuss their experiences and preferences with LDSS/N products at different stages. The cohort study involves repeated HIV and HCV antibody testing and behavioral surveys to assess uptake and impact over 18 months. Additional data collection includes routine program records and interviews with staff and stakeholders to evaluate program feasibility and effectiveness. The study will also use mathematical modeling to estimate the public health impact and cost-effectiveness of LDSS/N distribution in these settings.

Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries