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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later Dec 2026 → Nov 2027
See other at-risk trials from Médecins du Monde

Record History

  1. Primary completion pushed from Dec 2026 to Nov 2027 Primary endpoints: details revised at 1 of 1 entry · Completion pushed from Dec 2026 to Dec 2027 · Interventions: HIV rapid Diagnostic Test (Device), Hepatitis C Antibody Rapid Diagnostic Test (Device), Low dead-space syringes/needles (Device) to HIV rapid Diagnostic Test (Device), Hepatitis C Antibody Rapid Diagnostic Test (Device), Low dead-space syringes/needles (Device) · 2 more Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Completion pushed from Dec 2026 to Dec 2027
    • Interventions: HIV rapid Diagnostic Test (Device), Hepatitis C Antibody Rapid Diagnostic Test (Device), Low dead-space syringes/needles (Device) to HIV rapid Diagnostic Test (Device), Hepatitis C Antibody Rapid Diagnostic Test (Device), Low dead-space syringes/needles (Device)
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 7 of 7 entries
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 9 · Start date changed from estimate of Sep 2024 to Sep 13, 2024v3 Show 2 more changesShow less
    • Study sites: 0 to 9
    • Start date changed from estimate of Sep 2024 to Sep 13, 2024
  3. Secondary endpoints revised (7)v2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06395129
Lead Sponsor Médecins du Monde
Collaborators: UNITAID, Burnet Institute, International Network of People who Use Drugs, University of Bristol, Frontline AIDS, Caritas, Drug-free and preventitve healthcare organisation Nigeria, National Viral Hepatitis and STI Control Program Nigeria, PATH, Population Services International, London School of Hygiene and Tropical Medicine
Conditions Drug Use, Hepatitis, Hiv
Enrollment 2,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov