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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how people who use drugs perceive and access COVID-19 vaccines, and why some might hesitate or face barriers to vaccination. The study will examine these issues through a behavioral intervention, which targets changes in behaviors and attitudes. It is ideal for individuals who have used opioids in the last two weeks. Participation could help improve vaccine access and understanding for others in similar situations. As an unphased trial, this study provides a unique opportunity to contribute to important research that could lead to better health outcomes for communities facing similar challenges.

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 prior data suggests that this intervention test is safe?

Studies have shown that programs designed to reduce HIV risk are generally safe and manageable. Research indicates these programs can change behaviors that might lead to HIV infection without causing harm. Many reviews have confirmed that participants usually do not experience negative side effects. Instead, they often gain increased awareness and adopt better health practices. Based on past research, participating in trials with such programs is considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a behavioral intervention for HIV prevention, which is a fresh approach compared to standard drug-based options like antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). Unlike these conventional treatments that rely on medication to prevent HIV infection, this intervention focuses on changing behaviors and environments to reduce risk. This could be a game-changer by potentially offering an effective, non-pharmacological method for HIV prevention, widening the scope of prevention strategies and possibly reducing reliance on daily medication.

What evidence suggests that this trial's treatments could be effective?

This trial will evaluate a behavioral intervention designed to reduce the risk of HIV. Research has shown that behavioral programs can lower HIV risk, often resulting in positive health changes like increased condom use and reduced HIV rates. Meta-analyses have found that these programs successfully reduce risky behaviors. Although they generally work well for many groups, they are not always as effective for people who inject drugs. Overall, evidence supports using behavioral programs to help prevent HIV. ^{1 3 4 6 7}

Who Is on the Research Team?

Carl Latkin, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6530773/

Effects of Behavioral Intervention Content on HIV Prevention ... Numerous meta-analyses have examined the success of trials of interventions to reduce the behavioral risk of acquiring or transmitting HIV.

2. nature.com nature.com/articles/s41598-020-58767-0

Effectiveness of interventions for changing HIV related risk ... Overall, behavioural interventions were found to be effective in terms of reducing HIV risk behaviours among FSW, MSM and TG, but not among PWID ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8885930/

Behavioral and social interventions to promote optimal HIV ... In this paper, we provide a review of behavioral and social intervention research in the United States over the past year (September 1, 2020 to September 23, ...

4. link.springer.com link.springer.com/article/10.1007/s10461-025-04745-4

A Systematic Review of the Effectiveness of HIV Prevention ... Most studies found that interventions were associated with positive health-related changes, such as reduced HIV incidence, increased condom use ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379706005551

The Effectiveness of Individual-, Group ... The evidence found in our review shows that individual-level, group-level, and community-level HIV behavioral interventions are effective in reducing the odds ...

6. cdc.gov cdc.gov/hiv-data/about/index.html

About HIV Surveillance and Monitoring | HIV Data CDC uses data from public health labs, healthcare systems, and population surveys to capture information about people with, or with risk factors for, HIV.

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT01752777

Behavioral Intervention to Enhance HIV Test/Treat ... This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk ...