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RECRUITING
NCT06395129

Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries

Sponsor: Médecins du Monde

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2400

Start Date

2024-09-13

Completion Date

2026-12

Last Updated

2025-10-01

Healthy Volunteers

Yes

Interventions

DEVICE

Low dead-space syringes/needles

LDSS/N are a type of syringe/needle which retains less residual blood following an injecting event when compared to HDSS/N.

DEVICE

Hepatitis C Antibody Rapid Diagnostic Test

Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months

DEVICE

HIV rapid Diagnostic Test

Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months

Locations (9)

Real World Real People

Yerevan, Armenia

Step to Future

Gori, Georgia

New Vector

Rustavi, Georgia

Hepa+

Tbilisi, Georgia

Mukikute

Dar es Salaam, Tanzania

Peer 2 Peer

Dar es Salaam, Tanzania

Yovaribe

Ilala, Tanzania

Mefada

Kinondoni, Tanzania

STEPS Tanzania

Ubungo, Tanzania