Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
Recruiting · NCT06395129 · Observational (researchers observe without assigning treatment) · Lead sponsor: Médecins du Monde
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
9 locations listed.
- Mukikute - Dar es Salaam, Tanzania
- Peer 2 Peer - Dar es Salaam, Tanzania
- Step to Future - Gori, Georgia
- Yovaribe - Ilala, Tanzania
- Mefada - Kinondoni, Tanzania
- New Vector - Rustavi, Georgia
- Hepa+ - Tbilisi, Georgia
- STEPS Tanzania - Ubungo, Tanzania
- Real World Real People - Yerevan, Armenia