Targeted Injection Settings for HIV Prevention

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Must be taking: Opioids

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

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

What data supports the effectiveness of this treatment for HIV prevention?

Research shows that antiretroviral therapy (ART) can prevent HIV transmission and that starting treatment soon after diagnosis is beneficial. A model suggests that testing communities annually and treating all infected individuals immediately could prevent millions of AIDS-related deaths and help control the epidemic. ^{1 2 3 4 5}

How does this treatment for HIV prevention differ from other treatments?

This treatment is unique because it involves targeted injection settings specifically for HIV prevention among injecting drug users, focusing on behavior change and retention in trials, which is different from standard treatments that primarily focus on medication or vaccines. ^{1 6 7 8 9}

What is the purpose of this trial?

Conduct a study of people who use drugs (PWUD) perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers

Research Team

Carl Latkin, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

This trial is for people who have used opioids in the last two weeks. It's focused on understanding their views on COVID-19 vaccines, access to these vaccines, and what might be stopping them from getting vaccinated. There are no specific exclusion criteria listed.

Inclusion Criteria

Opioid use in prior 2 weeks

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Qualitative Assessment

Conduct qualitative rapid longitudinal assessment of PWUD's perceptions of and access to COVID-19 vaccines, reasons for vaccine hesitancy/barriers, and changes in social network dynamics.

52 weeks

Biweekly interviews

App Development and Testing

Development of an app to provide real-time information on COVID-19 vaccine availability and risk reduction resources. Testing with 20 PWUD.

Ongoing

Peer Education Training

Develop training materials and pilot training of 40 PWUD to promote vaccine uptake. Includes pre- and post-surveys and daily check-ins.

4 sessions

Follow-up

Participants are monitored for vaccine acceptance and effectiveness of peer education.

1 month

Treatment Details

Interventions

• Intervention test

Trial Overview The study isn't testing a new drug or treatment. Instead, it's analyzing how people who inject drugs feel about COVID-19 vaccines and identifying any obstacles they face in getting vaccinated.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

behavioral intervention

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Treatment as prevention among injecting drug users; extrapolating from the Amsterdam cohort study. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

HIV Testing With and Without a Clinical Consultation Among Men Who Have Sex With Men: A Randomized Controlled Trial. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Antiretroviral therapy initiated soon after HIV diagnosis as standard care: potential to save lives? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Missed Opportunities for Human Immunodeficiency Virus (HIV) Testing During Injection Drug Use-Related Healthcare Encounters Among a Cohort of Persons Who Inject Drugs With HIV Diagnosed During an Outbreak-Cincinnati/Northern Kentucky, 2017-2018. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Preparations for AIDS vaccine trials. Retention, behavior change, and HIV-seroconversion among injecting drug users (IDUs) and sexual partners of IDUs. [2007]

7. England pubmed.ncbi.nlm.nih.gov

HIV testing and unreported HIV positivity among injecting drug users in London. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Human Immunodeficiency Virus Testing, Diagnosis, Linkage to Care, and Prevention Services Among Persons Who Inject Drugs, United States, 2012-2017. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Risk behavior and HIV seroincidence among out-of-treatment injection drug users: a four-year prospective study. [2019]