NCT06395129 Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
| NCT ID | NCT06395129 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Médecins du Monde |
| Condition | Drug Use |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2024-09-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,400 participants in total. It began in 2024-09-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Implementation and evaluation of a distribution program for low dead-space syringes/needles (LDSS/N) in Armenia, Georgia, and Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to generate evidence on best practice LDSS/N distribution programs which will enhance acceptability and sustain high levels of LDSS/N uptake. People who inject drugs and access needle and syringe programs will be invited to attend up to three focus group discussion rounds (with 25 participants in each focus group round) to inform and provide feedback on a concurrent distribution program of LDSS/N. Throughout distribution, a cohort study will be run alongside distribution with 240 participants enrolled per country (with the exception of Nigeria, where 480 participants will be recruited) who will undergo HIV and HCV testing and answer surveys on their sociodemographic and behavioral status. Key informant interviews will also be held with participating staff and stakeholders to evaluate the feasibility and acceptability of this program. Primary outcomes assessed through this study include 1) community values and preferences for LDSS/N, 2) barriers and facilitators to accessing LDSS/N, 3) feasibility and effectiveness of the distribution program on increasing LDSS/N uptake, 4) model the potential public health impact and cost effectiveness of LDSS/N distribution in this setting.
Eligibility Criteria
Inclusion Criteria: * Aged ≥18 years (note that country-specific protocols may include participants aged ≥16 where appropriate and relevant); * Reporting a history of recent (past month) injection drug use; * Accessing the NSP to receive injecting equipment at either a facility, mobile service or through outreach and have an accompanying assigned program unique ID; * Able to understand and communicate in the local language(s); * If self-reporting HCV/HIV negative status, interested in and agreeing to undergo HCV and HIV testing; and * Willing and able to provide informed consent to take part in the study. Exclusion Criteria: * N/A
Contact & Investigator
Mark Stoové
PRINCIPAL INVESTIGATOR
Burnet
Frequently Asked Questions
Who can join the NCT06395129 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06395129 currently recruiting?
Yes, NCT06395129 is actively recruiting participants. Contact the research team at bridget.draper@burnet.edu.au for enrollment information.
Where is the NCT06395129 trial being conducted?
This trial is being conducted at Yerevan, Armenia, Gori, Georgia, Rustavi, Georgia, Tbilisi, Georgia and 5 additional locations.
Who is sponsoring the NCT06395129 clinical trial?
NCT06395129 is sponsored by Médecins du Monde. The principal investigator is Mark Stoové at Burnet. The trial plans to enroll 2,400 participants.