Needle Exchange Programs for HIV Prevention

Recruiting at 8 trial locations

Overseen By Nadine Kronfli

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

548 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve needle exchange programs in Canadian federal prisons to reduce the spread of HIV among people who inject drugs. The study aims to understand what helps or hinders these programs and seeks ways to make them more effective and lasting. Participants will go through different phases: a control period, the implementation of NIATx (a process improvement model), and a maintenance phase. Anyone incarcerated at one of the participating prisons during the study period can join the trial. As an unphased trial, it offers participants the chance to contribute to meaningful improvements in public health initiatives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for improving needle exchange programs in prisons?

Research has shown that needle exchange programs are safe and effective. Studies over nearly 30 years indicate these programs do not increase drug use or crime. They also help reduce HIV infections among users. For instance, in New York, one study found that these programs prevented about 87 new HIV infections in just one year. This evidence suggests that the NIATx approach, which enhances the operation of these programs, is likely safe and well-accepted by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Needle Exchange Programs for HIV Prevention trial because it explores the potential impact of a unique implementation strategy called NIATx. Unlike traditional needle exchange programs, which primarily focus on the distribution and collection of syringes, NIATx aims to streamline processes and improve access to these programs by addressing organizational barriers and enhancing service delivery. This approach could significantly increase participation and retention rates, ultimately reducing the spread of HIV more effectively. By testing different timing strategies for implementing NIATx, the trial hopes to uncover the optimal way to maximize benefits, offering valuable insights for public health interventions.

What evidence suggests that this trial's treatments could be effective for improving needle exchange programs in prisons?

Research has shown that needle exchange programs (NEPs) can significantly reduce the spread of HIV among people who inject drugs. In cities with NEPs, the rate of HIV infection has dropped by about 33%. Conversely, cities without NEPs have experienced a 5.9% annual increase in HIV cases. Needle exchange programs also promote safer needle use, further lowering the risk of bloodborne infections. This evidence suggests that implementing such programs in prisons could effectively reduce HIV transmission among inmates who inject drugs. The trial will evaluate the effectiveness of the NIATx model in implementing NEPs, with participants assigned to different groups to assess the impact over various timeframes. ^{2 3 6 7 8}

Who Is on the Research Team?

Frederick L. Altice

Principal Investigator

Yale University

Nadine Kronfli

Principal Investigator

Research Institute of the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for individuals in Canadian federal prisons, particularly those who inject drugs and may be at risk of HIV/AIDS or Hepatitis C. It aims to improve their participation in Prison Needle Exchange Programs (PNEPs) to reduce these risks.

Inclusion Criteria

All people incarcerated at a study site during the intervention period

Exclusion Criteria

This criterion does not apply to me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

Initial control period before the implementation of the NIATx strategy

6 months

NIATx Implementation

Implementation of the NIATx strategy to improve PNEP uptake

24 months

Maintenance

Post-intervention period to assess sustainability of the PNEP

12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• NIATx

Trial Overview The study tests the NIATx approach, a strategy designed to enhance the adoption and sustainability of PNEPs among prisoners. It's being conducted across nine federal prisons, including five women's facilities.

How Is the Trial Designed?

Group I: NIATx group 3 Experimental Treatment 1 Intervention

Control (month 13-18) then NIATx (month 19-42) then Maintenance (month 43-54)

Group II: NIATx group 2 Experimental Treatment 1 Intervention

Control (month 7-12) then NIATx (month 13-36) then Maintenance (month 37-48)

Group III: NIATx group 1 Experimental Treatment 1 Intervention

Control (month 1-6) then NIATx (month 7-30) then Maintenance (month 31-42)

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Kirby Institute

Collaborator

Trials

115

Recruited

194,000+

Burnet Institute

Collaborator

Trials

13

Recruited

74,500+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9269214/

Effectiveness of needle-exchange programmes for ... Findings: On average, seroprevalence increased by 5.9% per year in the 52 cities without NEPs, and decreased by 5.8% per year in the 29 cities with NEPs. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1307729/

The role of needle exchange programs in HIV prevention Incidence of HIV infection among needle exchange participants was estimated to have decreased by 33% as a result of the NEP. A series of Government- ...

3. stacks.cdc.gov stacks.cdc.gov/view/cdc/64711

The role of needle exchange programs in HIV prevention. Incidence of HIV infection among needle exchange participants was estimated to have decreased by 33% as a result of the NEP. A series of Government-commissioned ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-017-4210-2

Effectiveness of needle and syringe Programmes in people ... We found that NSP was effective in reducing HIV transmission and IRB among PWID, while there were mixed results regarding a reduction of HCV infection.

5. academyhealth.org academyhealth.org/node/2211

Effectiveness and cost-effectiveness of syringe exchange ... Effectiveness and cost-effectiveness of syringe exchange programs · Improving Injection-Related Practices. · Reducing Blood Borne Viral Infection.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK232343/

The Effects of Needle Exchange Programs - NCBI - NIH The report addressed all four possible negative outcomes: increases in (1) drug use by program participants; (2) new initiates to injection drug use; (3) drug ...

7. hiv.gov hiv.gov/federal-response/other-topics/syringe-services-programs

Syringe Services Programs Nearly 30 years of research shows that comprehensive SSPs are safe, effective, and cost-saving; do not increase illegal drug use or crime; and play an important ...

8. aclu.org aclu.org/documents/needle-exchange-programs-promote-public-safety

Needle Exchange Programs Promote Public Safety An analyses of a New York State-approved NEP found that during a 12-month period, an estimated 87 HIV infections were averted as a direct result ...