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NCT Number: NCT06103370

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

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).

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for index participants:

  • 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

Inclusion criteria

for network member participants:

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of HIV testing for Network Members

    Time frame: 3 months, 9-months

    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).

Secondary outcomes

  1. Proportion of HIV testing for Index and Network Members

    Time frame: 3- and 9-month follow-up

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

  2. Proportion of HIV testing for Index Members

    Time frame: 3- and 9-month follow-up

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

  3. Proportion of HIV negative participants who have used PrEP

    Time frame: 3- and 9-month follow-up

    Proportion of HIV-negative participants who have used PrEP (yes/no) since the previous study assessment (i.e., in the prior 3 or 6 months) among Network Members.

  4. Change in Knowledge of PrEP options

    Time frame: 3- and 9-month follow-up

    Knowledge of PrEP options and resources measured by questionnaire at 3 and 9 months among Network Members.

  5. Proportion of participants using anti-retroviral therapy (ART)

    Time frame: 3- and 9-month follow-up

    Proportion of participants living with HIV who reported they are currently using anti-retroviral therapy (ART), (yes/no) at the 3- or 9-month follow-up among Network Members.

  6. Proportion of participants who have used Medication for opioid use disorder (MOUD) uptake

    Time frame: 3- and 9-month follow-up

    Proportion of participants who report that they have used MOUD (yes/no) since the previous study assessment (i.e., in the prior 3 or 6 months) among Network Members.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregory Lucas, MD

CONTACT

[email protected]

410-614-0560

Oluwaseun Falade-Nwulia, MBBS, MPH

CONTACT

[email protected]

410-550-6234

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Maryland Department of Health and Mental Hygiene
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 26, 2023
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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