Actively Recruiting
Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
Led by Médecins du Monde · Updated on 2025-10-01
2400
Participants Needed
9
Research Sites
115 weeks
Total Duration
On this page
Sponsors
M
Médecins du Monde
Lead Sponsor
U
UNITAID
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older (some country protocols may include participants aged 16 and above where appropriate)
- History of injection drug use in the past month
- Accessing needle and syringe program services at a facility, mobile service, or outreach with an assigned unique program ID
- Able to understand and communicate in the local language(s)
- If self-reporting negative HIV and Hepatitis C status, willing to undergo HIV and Hepatitis C testing
- Willing and able to provide informed consent to participate in the study
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Real World Real People
Yerevan, Armenia
Actively Recruiting
2
Step to Future
Gori, Georgia
Actively Recruiting
3
New Vector
Rustavi, Georgia
Actively Recruiting
4
Hepa+
Tbilisi, Georgia
Actively Recruiting
5
Mukikute
Dar es Salaam, Tanzania
Actively Recruiting
6
Peer 2 Peer
Dar es Salaam, Tanzania
Actively Recruiting
7
Yovaribe
Ilala, Tanzania
Actively Recruiting
8
Mefada
Kinondoni, Tanzania
Actively Recruiting
9
STEPS Tanzania
Ubungo, Tanzania
Actively Recruiting
Research Team
B
Bridget Draper
CONTACT
M
Mark Stoové
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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