RecruitingNCT06395129

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


Sponsor

Médecins du Monde

Enrollment

2,400 participants

Start Date

Sep 13, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This public health study distributes low dead-space syringes and needles — equipment that retains less blood after injection — to people who inject drugs, to see if this reduces HIV and hepatitis C transmission. **You may be eligible if...** - You currently inject drugs - You are at least 18 years old - You are willing to receive and use the provided injecting equipment - You are able to attend follow-up visits **You may NOT be eligible if...** - You are not currently injecting drugs - You are under 18 years old - You are unable or unwilling to complete follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELow 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.

DEVICEHepatitis C Antibody Rapid Diagnostic Test

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

DEVICEHIV 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

View Full Details on ClinicalTrials.gov

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NCT06395129


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