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

September 25, 2025 updated by: Médecins du Monde

Implementing a Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries: a Process and Outcome Evaluation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will recruit people who inject drugs to inform and evaluate the selection and distribution of low dead-space needles and syringes (LDSS/N) at their existing NSP services.

The interventions include: low- dead-space needles and syringes; and knowledge mobilisation through Focus Group Discussions (FGDs) and peer education.

Specifically, in Phase 1, people who inject drugs will be recruited at each study site to participate in FGDs, in which they will be presented with a selection of new LDSS/N products, provided information about their advantages regarding blood borne virus (BBV) transmission risk, and invited to discuss their values and preferences regarding needle- and syringe choice to inform the selection of LDSS/N to be piloted for scaled up distribution at their study sites.

Following the FGDs, during Phase 2 people who inject drugs who are registered clients at participating NSP services can enroll in a 6-week pilot period during which they will have access to a small selection of new LDSS/N products alongside the usual services they access at the study site or needle and syringe program (NSP). When the 6 week pilot phase concludes, participants will be invited to participate in a second round of FGDs, where they will be asked reflect on their experiences using the new LDSS/N products and share their opinions on which products to select for scaled up distribution to all clients accessing the study sites.

In Phase 3, a small selection LDSS/N (2-5) will be made available alongside the usual needles- and syringes and other existing harm reduction services at the study site/NSPs. During this period, two forms of data will be collected, 1) routine programmatic data, and 2) data from a concurrent cohort study.

The routine programmatic data collected will include information already routinely collected by the sites when individuals attend (site specific client ID, type and quantity of needles/syringes (N/S) collected) along with two additional questions 'Did you use a LDSS/N the last time you injected?" and "Thinking about the last week, for how many of your injections did you use a LDSS/N?'. No identifiable data will be recorded as part of routine programmatic data collection, therefore individuals included in this process are not considered 'participants' and will not undergo informed consent. This data will be used for the purposes of monitoring and evaluating LDSS/N uptake.

Alongside this distribution period, 240 people per country who inject drugs accessing participating study sites will be recruited into an observational cohort study. Participants will be asked to undergo HIV and HCV antibody testing and to answer surveys on demographic and behavioral activities at four timepoints (baseline, 6-months, 12-months, 18-months).

At the conclusion of the distribution period, a third round of FGDs will be run to assess the acceptability and impact of the LDSS/N distribution program. Key informant interviews with study staff and key stakeholders will also be completed to explore the feasibility and effectiveness of the LDSS/N program.

Following all data collection, mathematical modelling will estimate the impact and cost-effectiveness of scaling up LDSS/N for people who inject drugs at a country-level, including modelling the impact on BBV transmission.

Study Type

Observational

Enrollment (Estimated)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

People aged 18+ who report injecting drug use

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort study

All participants in the cohort study will undergo surveys, HIV, and HCV testing at four possible timepoints (baseline, 6-months, 12-months, and if time permits 18-months).

They will also have access to the study sites usual services, and the introduced LDSS/N.
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.
Other Names:
  • LDSS/N
Device: Hepatitis C Antibody Rapid Diagnostic Test
Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months
Other Names:
  • HCV RDT
Device: HIV rapid Diagnostic Test
Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months
Other Names:
  • HIV RDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of a community values and preferences informed LDSS/N distribution program on increasing LDSS uptake among people who inject drugs
Time Frame: 18 months
Defined as reported exclusive use of LDSS/N vs not exclusive use of LDSS/N
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding community values and preferences for LDSS/N in the context of other harm reduction supplies available to people who inject drugs
Time Frame: 18 months
Identified through focus group discussions
18 months
Barriers and facilitators to access and uptake of LDSS/N among people who inject drugs
Time Frame: 18 months
Assessed through surveys and focus group discussions
18 months
Identifying the enablers and challenges affecting the supply chain for LDSS/N
Time Frame: 18 months
18 months
Document the legal, social, and regularity enablers and challenges affecting the successful introduction and maintenance of LDSS/N distribution
Time Frame: 18 months
18 months
Evaluate LDSS/N demand creation approaches
Time Frame: 18 months
18 months
Differences in blood borne virus (HIV/HCV) incidence between those who exclusively use LDSS/N and those who do not
Time Frame: 18 months
18 months
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
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Médecins du Monde

Collaborators

London School of Hygiene and Tropical Medicine
University of Bristol
PATH
UNITAID
Burnet Institute
Population Services International
Frontline AIDS
International Network of People who Use Drugs
Caritas
Drug-free and preventitve healthcare organisation Nigeria
National Viral Hepatitis and STI Control Program Nigeria

Investigators

  • Principal Investigator: Mark Stoové, Burnet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 1, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HepC LDSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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