Social Network Intervention for HIV Prevention

Overseen By Gregory Lucas, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Lacking capacity to consent

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

Compensation: Varies

Number of Visits: 3

360 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the effectiveness of a social network intervention to recruit people who inject drugs and their networks for HIV testing and linkage to HIV prevention and treatment services in Maryland. Study aims are to determine the effectiveness of a social network driven intervention to increase: * HIV testing (primary); * PrEP knowledge; * Uptake of HIV services and pre-exposure prophylaxis (PrEP); * Uptake of medication for opioid use disorder (MOUD) initiation. Eligible participants who access syringe service programs (SSPs) serving two counties in Maryland and their risk network members (NMs) will be recruited using an established network inventory and coupon recruitment method. When an index successfully recruits NMs, the index-NM cluster will be randomized to either a peer-educator intervention arm or an equal-attention control arm. Index participants randomized to the peer-educator intervention arm will complete a training program adapted with stakeholder input to context that emphasizes effective communication, frequent HIV testing, and awareness of evidence-based HIV prevention and treatment services. An important innovation to the network intervention will be training indexes to use and distribute HIV self-test kits and naloxone to their NMs. Index participants randomized to the equal-attention control arm will receive training sessions focused on the opioid overdose epidemic and will not include any training to serve as a peer educator. All participants (indexes and NMs) will complete study assessments at baseline and at 3 and 9 months. We will compare the peer-educator intervention group and the equal-attention control group on rates of HIV testing, knowledge of PrEP options and resources, and rates of initiation of HIV treatment, PrEP, and MOUD treatment since the previous assessment (past 3 or 6 months).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators for more details.

What data supports the effectiveness of the treatment Peer-educator-based network for HIV prevention?

Research shows that peer-educator-based interventions can effectively increase HIV prevention behaviors, such as linking people to pre-exposure prophylaxis (PrEP) care and reducing stigma. These interventions have been successful in various settings, including among young Black men who have sex with men and people with HIV in Uganda, by empowering individuals to become advocates within their social networks. ^{1 2 3 4 5}

Is the Social Network Intervention for HIV Prevention safe for humans?

The Social Network Intervention, which involves peer education to reduce HIV risk behaviors, has been studied in various settings and has not shown any significant safety concerns. Participants in these studies did not report adverse effects related to the intervention, suggesting it is generally safe for humans. ^{1 6 7 8 9}

How does the Social Network Intervention for HIV Prevention differ from other treatments for HIV prevention?

This treatment is unique because it uses social network interventions, focusing on peer change agents (PCAs) to influence behavior within high-risk groups, rather than relying solely on medical or pharmaceutical approaches. It leverages the power of social connections to promote HIV risk reduction, making it distinct from traditional prevention methods that do not typically involve social network dynamics. ^{6 10 11 12 13}

Research Team

Oluwaseun Falade-Nwulia, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for adults over 18 in Maryland who use syringe service programs and can recruit at least one drug-using peer. They must speak English, be willing to undergo training, and discuss HIV prevention. People unable to consent are excluded.

Inclusion Criteria

I have a valid coupon or remember the 3-digit ID number.

Inclusion criteria for index participants:

I am 18 years old or older.

Exclusion Criteria

I am unable to make medical decisions for myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete initial study assessments and are randomized into intervention or control arms

1 week

1 visit (in-person)

Intervention

Participants in the peer-educator arm receive training on communication, HIV testing, and prevention services; control arm receives training on opioid overdose

3 months

Ongoing sessions (in-person and virtual)

Follow-up

Participants are monitored for HIV testing, PrEP uptake, and MOUD initiation at 3 and 9 months

9 months

2 visits (in-person) at 3 and 9 months

Treatment Details

Interventions

• Peer-educator-based network

Trial Overview The study tests if a peer-educator network can increase HIV testing, PrEP knowledge, uptake of HIV services/PrEP, and medication for opioid use disorder among people who inject drugs compared to an overdose education control group.

Participant Groups

Group I: Peer-educator-based network intervention Experimental Treatment 1 Intervention

Indexes randomized to the intervention arm will complete a training program that emphasizes effective communication, frequent HIV testing, and awareness of evidence-based HIV prevention and treatment services. An important innovation to the network intervention will be training indexes to use and distribute HIV self-test kits and naloxone to their network members (NMs).

Group II: Equal-attention control Active Control 1 Intervention

This group will receive training sessions that will be focused on the opioid overdose epidemic and will not include any training to serve as a peer educator.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Maryland Department of Health and Mental Hygiene

Collaborator

Trials

9

Recruited

5,000+

References

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

Promoting Transformative Community Change for Equitable Health: Peer Education and Intervention for Pre-Exposure HIV Prophylaxis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The STEP into Action study: a peer-based, personal risk network-focused HIV prevention intervention with injection drug users in Baltimore, Maryland. [2021]

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

A Pragmatic Randomized Controlled Trial to Increase PrEP Uptake for HIV Prevention: 55-Week Results From PrEPChicago. [2023]

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

A Pilot Test of Game Changers, a Social Network Intervention to Empower People with HIV to be Prevention Advocates in Uganda. [2021]

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

Individual and Social Network Structure Characteristics Associated with Peer Change Agent Engagement and Impact in a PrEP Intervention. [2021]

6. England pubmed.ncbi.nlm.nih.gov

The efficacy of a network intervention to reduce HIV risk behaviors among drug users and risk partners in Chiang Mai, Thailand and Philadelphia, USA. [2021]

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

Does respondent driven sampling alter the social network composition and health-seeking behaviors of illicit drug users followed prospectively? [2021]

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

A peer-educator network HIV prevention intervention among injection drug users: results of a randomized controlled trial in St. Petersburg, Russia. [2021]

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

Diagnosing PrEP Communication Self-Efficacy in a Community-Based Peer Leader Intervention for Black Sexual Minority Men. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Candidate change agent identification among men at risk for HIV infection. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A new HIV prevention network approach: sociometric peer change agent selection. [2021]

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

Students together against negative decisions (STAND): evaluation of a school-based sexual risk reduction intervention in the rural south. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Analysis of online social networking peer health educators. [2022]