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

NCT06103370 | Recruiting DMC

• 2 other identifiers: IRB00374291R01DA058387
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Proportion of HIV testing for Network Members

  Proportion of Network Members (both study arms) who report that they conducted HIV testing since the previous study assessment (i.e., in the prior 3 or 6 months).

  3 months, 9-months

Secondary Outcomes (6)

• Proportion of HIV testing for Index and Network Members

  3- and 9-month follow-up

• Proportion of HIV testing for Index Members

  3- and 9-month follow-up

• Proportion of HIV negative participants who have used PrEP

  3- and 9-month follow-up

• Change in Knowledge of PrEP options

  3- and 9-month follow-up

• Proportion of participants using anti-retroviral therapy (ART)

  3- and 9-month follow-up

Study Arms (2)

Peer-educator-based network intervention

EXPERIMENTAL

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).

Behavioral: Peer-educator-based network

Equal-attention control

NO 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.

Interventions

Peer-educator-based network 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.

Peer-educator-based network intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals lacking the capacity to consent

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Maryland Department of Health and Mental Hygiene: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Frederick County Health Department, Street Safe Program

Frederick, Maryland, 21701, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Oluwaseun Falade-Nwulia, MBBS, MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluwaseun Falade-Nwulia, MBBS, MPH

CONTACT

410-550-6234; ofalade1@jhmi.edu

Gregory Lucas, MD

CONTACT

410-614-0560; glucas@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 26, 2023
• Study Start: October 28, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)