LINKED Intervention for HIV Prevention in Drug Addiction

Not yet recruiting at 2 trial locations
SW
Overseen BySuzan Walters, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the LINKED social network intervention, which aims to help people who inject drugs start using PrEP (a medicine that helps prevent HIV) and MOUD (treatment for opioid addiction). Participants will join one of two groups: the LINKED intervention group, which includes a peer-led workshop, or a control group that receives general attention. The trial seeks participants in the Los Angeles area who have injected drugs in the past three months, are not currently using PrEP or MOUD, and have tested negative for HIV. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve health outcomes for people who inject drugs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on PrEP or MOUD to participate.

What prior data suggests that the LINKED intervention is safe for people who inject drugs?

Research has shown that programs like LINKED yield promising results in reducing risky behaviors among people who inject drugs. One study found that similar programs significantly reduced behaviors that increase the risk of HIV, largely due to the involvement of peer health advocates. This suggests that LINKED could be well-received and effective, as it employs a peer-driven approach to promote safer practices.

Additionally, oral PrEP (pre-exposure prophylaxis), which LINKED aims to increase the use of, has reduced HIV cases by 49% among people who inject drugs. This indicates that the intervention related to PrEP might be safe and effective.

Overall, LINKED focuses on peer support and behavior change. Studies suggest that these types of programs can safely and effectively encourage healthier behaviors in high-risk groups.12345

Why are researchers excited about this trial?

Researchers are excited about the LINKED Intervention for HIV prevention in drug addiction because it offers a novel approach by using a peer change agent model. Unlike standard treatments that might rely on medication or more traditional counseling, LINKED involves a 3-hour workshop where participants engage in interactive learning and practice sessions. This method focuses on peer support and behavioral change, which could enhance engagement and effectiveness in preventing HIV among those struggling with drug addiction. By leveraging the influence of peers, the intervention aims to create a supportive community that facilitates positive change and adherence to prevention strategies.

What evidence suggests that the LINKED intervention is effective for HIV prevention in drug addiction?

Research has shown that certain programs help people who inject drugs reduce risky drug use and sexual behaviors. These programs lower the risk of HIV by encouraging healthier choices and actions. One review found that these programs lead to safer sexual practices and less drug use. In this trial, participants in the LINKED arm will receive a peer change agent intervention designed to promote healthier behaviors. Another study found that using both medication for opioid addiction and HIV treatment helps prevent and manage HIV. Overall, these programs effectively reduce HIV risk and promote healthier behaviors in this group.12567

Who Is on the Research Team?

SW

Suzan Walters, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for people who inject drugs (PWID) and are interested in improving their HIV prevention and substance use treatment. Participants should be willing to engage with the LINKED social network intervention or a control group activity, with follow-ups at 6 and 12 months.

Inclusion Criteria

I am over 18, work for TSP, and can consent to participate.
Aim 2 - Intervention: Is 18 years or older, Spends majority of their time in the Los Angeles, CA area where recruited, Able to complete surveys and group sessions in English, Self-reports to have injected drugs in the past 3 months, Self-reports HIV negative serostatus, Not currently on PrEP or MOUD, Not pregnant, If a network recruit: presents a valid recruitment coupon, Is capable and willing to provide consent
I am over 18, work for TSP, and can consent to participate.

Exclusion Criteria

Aims 1 and 3: Individuals who are not current TSP staff members will be excluded from participation
Aim 2: Under age 18, Does not spend majority of time in the Los Angeles, CA area where recruited, Unable to complete surveys and group sessions in English, Does not self-report injecting drugs in past 3 months, Self-reports HIV positive serostatus, Currently on PrEP or MOUD, Currently pregnant, If a network recruit: does not present a valid recruitment coupon

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the LINKED social network intervention or an equal-attention control intervention

3 hours
1 visit (in-person)

Follow-up

Participants are monitored for PrEP and MOUD uptake and adherence

12 months
Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • LINKED

Trial Overview

The study tests the LINKED intervention against an equal-attention control group to see if it helps PWID take up PrEP (a medication to prevent HIV) and MOUD (medications for opioid use disorder). It's a cluster randomized trial, meaning groups of participants are randomly assigned to interventions.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: LINKED InterventionExperimental Treatment1 Intervention
Group II: Equal-Attention ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Outcomes of a Peer HIV Prevention Program with Injection ...

Results indicated significant HIV risk reduction among all study participants, associated with significant health advocacy action conducted by PHAs, and a ...

Behavioral HIV risk reduction among people who inject drugs

Behavioral interventions reduce risk behaviors among people who inject drugs, especially when interventions target both drug risk and sexual risk behaviors, and ...

HIV prevention intervention for substance users: a review ...

The interventions reviewed demonstrate promising results for decreasing risky sexual practices for NIDUs and reducing high-risk drug practices for IDUs.

HPTN 094 Study Examines a Novel Way to Take Addiction ...

Primary outcomes were being alive at 26 weeks post-randomization, using MOUD, and ART for HIV prevention or care among people who inject drugs ...

Effectiveness of interventions for changing HIV related risk ...

HIV prevention interventions in Nepal have effectively reduced risky behaviours among female sex workers, men who have sex with men and transgender over the ...

Engagement and Substance Dependence in a Primary ...

Among people with substance dependence and HIV or high-risk for HIV, 64% engaged in an addiction treatment program integrated into primary care.

HIV Prevention Among People Who Inject Drugs (PWID)

Oral PrEP demonstrated 49% reduction in HIV incidence among PWID in an RCT, with ≥70% efficacy among those with detectable drug levels. Real- ...