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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Armenia
Real World Real People
RECRUITING
Yerevan
Georgia
Step to Future
RECRUITING
Gori
New Vector
RECRUITING
Rustavi
Hepa+
RECRUITING
Tbilisi
United Republic of Tanzania
Mukikute
RECRUITING
Dar Es Salaam
Peer 2 Peer
RECRUITING
Dar Es Salaam
Yovaribe
RECRUITING
Ilala
Mefada
RECRUITING
Kinondoni
STEPS Tanzania
RECRUITING
Ubungo
Contact Information
Primary
Bridget Draper
bridget.draper@burnet.edu.au
+61 413 272 698
Backup
Mark Stoové
mark.stoove@burnet.edu.au
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2026-12
Participants
Target number of participants: 2400
Treatments
Cohort study
All participants in the cohort study will undergo surveys, HIV, and HCV testing at four possible timepoints (baseline, 6-months, 12-months, and if time permits 18-months).~They will also have access to the study sites usual services, and the introduced LDSS/N.
Related Therapeutic Areas
Sponsors
Collaborators: PATH, National Viral Hepatitis and STI Control Program Nigeria, London School of Hygiene and Tropical Medicine, Burnet Institute, Caritas, UNITAID, University of Bristol, Population Services International, Frontline AIDS, International Network of People who Use Drugs, Drug-free and preventitve healthcare organisation Nigeria
Leads: Médecins du Monde

This content was sourced from clinicaltrials.gov