Low dead-space syringe and needle distribution for people who inject drugs in low- and middle-income countries

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

This program will test whether offering low dead-space syringes and needles to people who inject drugs at needle and syringe programs in several low- and middle-income countries increases acceptability and use of safer injecting equipment.

Quick facts

• Study type: Observational
• Enrollment: 2400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Médecins du Monde (Academic / other)
• Locations: 9 sites (Yerevan and 8 other locations)
• Trial ID: NCT06395129 on ClinicalTrials.gov

What this trial studies

The project uses focus group discussions with people who inject drugs to select preferred low dead-space syringe and needle (LDSS/N) products, followed by a six-week pilot period offering a small selection of those LDSS/N alongside usual services. A cohort of participants at each site will be enrolled for serial surveys and HIV/HCV rapid testing to monitor uptake, behaviors, and infection outcomes, with larger recruitment planned in Nigeria. Key informant interviews with staff and stakeholders will document implementation challenges and facilitators. Findings will inform selection and scaled distribution of 2–5 LDSS/N products at participating needle and syringe program sites across multiple countries.

Who should consider this trial

Good fit: Adults who report recent injection drug use, are registered clients of participating needle and syringe programs, can communicate in the local language(s), and are willing to provide consent and undergo HIV and HCV testing are ideal candidates.

Not a fit: People who do not inject drugs, do not access participating needle and syringe programs, are unwilling to try different syringe types, or already exclusively use low dead-space equipment may not receive additional benefit from this program.

Why it matters

Potential benefit: If successful, the program could increase use of safer low dead-space injecting equipment and help reduce HIV and hepatitis C transmission among people who inject drugs.

How similar studies have performed: Laboratory and community studies indicate LDSS/N retain less blood and may lower transmission risk, but real-world distribution program evidence in low- and middle-income countries is limited.

Eligibility criteria

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

Where this trial is running

Yerevan and 8 other locations

• Real World Real People — Yerevan, Armenia (Recruiting)
• Step to Future — Gori, Georgia (Recruiting)
• New Vector — Rustavi, Georgia (Recruiting)
• Hepa+ — Tbilisi, Georgia (Recruiting)
• Mukikute — Dar es Salaam, Tanzania (Recruiting)
• Peer 2 Peer — Dar es Salaam, Tanzania (Recruiting)
• Yovaribe — Ilala, Tanzania (Recruiting)
• Mefada — Kinondoni, Tanzania (Recruiting)
• STEPS Tanzania — Ubungo, Tanzania (Recruiting)

Study contacts

• Principal investigator: Mark Stoové — Burnet
• Study coordinator: Bridget Draper

Conditions Drug Use; Hepatitis; Hiv; Low dead-space needles and syringes; Qualitative interviews; LDSS/N; High dead space needles/syringes; Rapid diagnostic test