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
This trial accepts healthy volunteersQualifiers
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 population
People aged 18+ who report injecting drug use
Trial design
Cohort
Prospective
Treatments tested in this trial
Low dead-space syringes/needles
DeviceLDSS/N are a type of syringe/needle which retains less residual blood following an injecting event when compared to HDSS/N.
Hepatitis C Antibody Rapid Diagnostic Test
DeviceAdministered up to 4 times, at baseline, 6-months, 12-months, and 18-months
HIV rapid Diagnostic Test
DeviceAdministered up to 4 times, at baseline, 6-months, 12-months, and 18-months
Treatment groups
Trial outcomes
Primary outcomes
Effectiveness of a community values and preferences informed LDSS/N distribution program on increasing LDSS uptake among people who inject drugs
Defined as reported exclusive use of LDSS/N vs not exclusive use of LDSS/N
Secondary outcomes
Understanding community values and preferences for LDSS/N in the context of other harm reduction supplies available to people who inject drugs
Identified through focus group discussions
Barriers and facilitators to access and uptake of LDSS/N among people who inject drugs
Assessed through surveys and focus group discussions
Differences in blood borne virus (HIV/HCV) incidence between those who exclusively use LDSS/N and those who do not
Model the potential public health impact (HCV and HIV infections averted) and cost-effectiveness of LDSS/N distribution for people who inject drugs within harm reduction settings
Sponsors and contacts
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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