Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06395129

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here