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

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.

Conditions

• Drug Use
• Hepatitis
• Hiv

Interventions

DEVICE

Low dead-space syringes/needles

LDSS/N are a type of syringe/needle which retains less residual blood following an injecting event when compared to HDSS/N.

DEVICE

Hepatitis C Antibody Rapid Diagnostic Test

Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months

DEVICE

HIV rapid Diagnostic Test

Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months

Sponsors & Collaborators

• UNITAID

  collaborator OTHER

• Burnet Institute

  collaborator OTHER

• International Network of People who Use Drugs

  collaborator UNKNOWN

• University of Bristol

  collaborator OTHER

• Frontline AIDS

  collaborator OTHER

• Caritas

  collaborator UNKNOWN

• Drug-free and preventitve healthcare organisation Nigeria

  collaborator UNKNOWN

• National Viral Hepatitis and STI Control Program Nigeria

  collaborator UNKNOWN

• PATH

  collaborator OTHER

• Population Services International

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Médecins du Monde

  lead OTHER

Principal Investigators

• Mark Stoové · Burnet

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-09-13

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Device

Yes

Countries

• Armenia
• Georgia
• Tanzania

Study Locations