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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMédecins du Monde

About this trial

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

Qualifiers

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);

Disqualifiers

N/A

Trial design

Treatments tested in this trial

  • Low dead-space syringes/needles
  • Hepatitis C Antibody Rapid Diagnostic Test
  • HIV rapid Diagnostic Test

Treatment groups

2,400 Participants
are divided into 1 treatment group

Sponsors and collaborators

Médecins du Monde

Lead sponsor

UNITAID

Collaborator

Burnet Institute

Collaborator

International Network of People who Use Drugs

Collaborator

University of Bristol

Collaborator

Frontline AIDS

Collaborator

Caritas

Collaborator

Drug-free and preventitve healthcare organisation Nigeria

Collaborator

National Viral Hepatitis and STI Control Program Nigeria

Collaborator

PATH

Collaborator

Population Services International

Collaborator

London School of Hygiene and Tropical Medicine

Collaborator