NCT06395129Recruiting
Low Dead-space Injecting Equipment Distribution Program 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
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2400 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 13 Sept 2024
- Primary completion date
- Nov 2027
- Lead sponsor
- Médecins du Monde
- Diseases
- HIV
- NCT number
- NCT06395129
What you commit to
- Study type: Observational
- Planned participants: 2400
- From 13 Sept 2024 to the primary completion date, Nov 2027
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- N/A
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Real World Real People Coordinator of this site? Confirm its status | Yerevan | Armenia | Recruiting |
| Step to Future Coordinator of this site? Confirm its status | Gori | Georgia | Recruiting |
| New Vector Coordinator of this site? Confirm its status | Rustavi | Georgia | Recruiting |
| Hepa+ Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Peer 2 Peer Coordinator of this site? Confirm its status | Dar es Salaam | Tanzania | Recruiting |
| Mukikute Coordinator of this site? Confirm its status | Dar es Salaam | Tanzania | Recruiting |
| Yovaribe Coordinator of this site? Confirm its status | Ilala | Tanzania | Recruiting |
| Mefada Coordinator of this site? Confirm its status | Kinondoni | Tanzania | Recruiting |
| STEPS Tanzania Coordinator of this site? Confirm its status | Ubungo | Tanzania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.