Syringe Service Based Telemedicine and Social Network Driven HIV Prevention Service Implementation

NCT ID: NCT06103370

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-28
• Study Completion Date: 2028-11-30

Brief Summary

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).

Conditions

HIV Infections; Substance Use Disorders; Addiction; Opioid Use; Drug Use; Intravenous Drug Usage

Keywords

Injection Drug Use; HIV Prevention; Social Networks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Peer-educator-based network 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 Type: EXPERIMENTAL

Peer-educator-based network

Intervention Type: BEHAVIORAL

The intervention is a social network-based method of dispersing HIV knowledge, HIV self-testing (HIVST) kits, and naloxone in social networks of people who inject drugs (PWID). It targets index participants (peers) to receive training on HIVST, peer education, and linkage to syringe service programs (SSPs) for HIV services.

Equal-attention control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peer-educator-based network

The intervention is a social network-based method of dispersing HIV knowledge, HIV self-testing (HIVST) kits, and naloxone in social networks of people who inject drugs (PWID). It targets index participants (peers) to receive training on HIVST, peer education, and linkage to syringe service programs (SSPs) for HIV services.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 18 or older
• Self-reported injection drug use in the prior month
• Accessed services at the SSP in the prior 3 months
• Willing to undergo training and attend weekly booster group sessions
• Able to recruit at least 1 drug use Network Member (NM) into study
• Willing to talk with peers about PWID topics such as HIV prevention and care
• Not previously enrolled in the study as index or NM
• English-speaking

• Aged 18 or older
• Self-reported injection drug use in the prior month
• Have a valid coupon or able to recall the 3-digit ID number
• Not previously enrolled in the study as index or NM
• English-speaking

Exclusion Criteria

• Individuals lacking the capacity to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Maryland Department of Health and Mental Hygiene

OTHER_GOV

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oluwaseun Falade-Nwulia, MBBS, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: NOT_YET_RECRUITING

Frederick County Health Department, Street Safe Program

Frederick, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Oluwaseun Falade-Nwulia, MBBS, MPH

Role: CONTACT

Phone: 410-550-6234

Email: ofalade1@jhmi.edu

Gregory Lucas, MD

Role: CONTACT

Phone: 410-614-0560

Email: glucas@jhmi.edu

Facility Contacts

Marisa Shields

Role: primary

Other Identifiers

R01DA058387

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00374291

Identifier Type: -

Identifier Source: org_study_id