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

Hiv Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395129
• Other study ID #: HepC LDSS
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Médecins du Monde
• Contact: Bridget Draper
• Phone: +61 413 272 698
• Email: bridget.draper[@]burnet.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study will recruit people who inject drugs to inform and evaluate the selection and distribution of low dead-space needles and syringes (LDSS/N) at their existing NSP services.

The interventions include: low- dead-space needles and syringes; and knowledge mobilisation through Focus Group Discussions (FGDs) and peer education.

Specifically, in Phase 1, people who inject drugs will be recruited at each study site to participate in FGDs, in which they will be presented with a selection of new LDSS/N products, provided information about their advantages regarding blood borne virus (BBV) transmission risk, and invited to discuss their values and preferences regarding needle- and syringe choice to inform the selection of LDSS/N to be piloted for scaled up distribution at their study sites.

Following the FGDs, during Phase 2 people who inject drugs who are registered clients at participating NSP services can enroll in a 6-week pilot period during which they will have access to a small selection of new LDSS/N products alongside the usual services they access at the study site or needle and syringe program (NSP). When the 6 week pilot phase concludes, participants will be invited to participate in a second round of FGDs, where they will be asked reflect on their experiences using the new LDSS/N products and share their opinions on which products to select for scaled up distribution to all clients accessing the study sites.

In Phase 3, a small selection LDSS/N (2-5) will be made available alongside the usual needles- and syringes and other existing harm reduction services at the study site/NSPs. During this period, two forms of data will be collected, 1) routine programmatic data, and 2) data from a concurrent cohort study.

The routine programmatic data collected will include information already routinely collected by the sites when individuals attend (site specific client ID, type and quantity of needles/syringes (N/S) collected) along with two additional questions 'Did you use a LDSS/N the last time you injected?" and "Thinking about the last week, for how many of your injections did you use a LDSS/N?'. No identifiable data will be recorded as part of routine programmatic data collection, therefore individuals included in this process are not considered 'participants' and will not undergo informed consent. This data will be used for the purposes of monitoring and evaluating LDSS/N uptake.

Alongside this distribution period, 240 people per country who inject drugs accessing participating study sites will be recruited into an observational cohort study. Participants will be asked to undergo HIV and HCV antibody testing and to answer surveys on demographic and behavioral activities at four timepoints (baseline, 6-months, 12-months, 18-months).

At the conclusion of the distribution period, a third round of FGDs will be run to assess the acceptability and impact of the LDSS/N distribution program. Key informant interviews with study staff and key stakeholders will also be completed to explore the feasibility and effectiveness of the LDSS/N program.

Following all data collection, mathematical modelling will estimate the impact and cost-effectiveness of scaling up LDSS/N for people who inject drugs at a country-level, including modelling the impact on BBV transmission.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2400
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Drug Use
• Hepatitis
• Hiv

Intervention

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.
• Hepatitis C Antibody Rapid Diagnostic Test
Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months
• HIV rapid Diagnostic Test
Administered up to 4 times, at baseline, 6-months, 12-months, and 18-months

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor	Collaborator
Médecins du Monde	Burnet Institute, Caritas, Drug-free and preventitve healthcare organisation Nigeria, Frontline AIDS, International Network of People who Use Drugs, LSHTM, National Viral Hepatitis and STI Control Program Nigeria, PATH, Population Services International, UNITAID, University of Bristol

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of a community values and preferences informed LDSS/N distribution program on increasing LDSS uptake among people who inject drugs	Defined as reported exclusive use of LDSS/N vs not exclusive use of LDSS/N	18 months
Secondary	Understanding community values and preferences for LDSS/N in the context of other harm reduction supplies available to people who inject drugs	Identified through focus group discussions	18 months
Secondary	Barriers and facilitators to access and uptake of LDSS/N among people who inject drugs	Assessed through surveys and focus group discussions	18 months
Secondary	Differences in blood borne virus (HIV/HCV) incidence between those who exclusively use LDSS/N and those who do not		18 months
Secondary	Model the potential public health impact (HCV and HIV infections averted) and cost-effectiveness of LDSS/N distribution for people who inject drugs within harm reduction settings		18 months
Secondary	Identifying the enablers and challenges affecting the supply chain for LDSS/N		18 months
Secondary	Document the legal, social, and regularity enablers and challenges affecting the successful introduction and maintenance of LDSS/N distribution		18 months
Secondary	Evaluate LDSS/N demand creation approaches		18 months