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Recruiting NCT06103370

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

No phase Interventional HIV Infections Substance Use Disorders Addiction Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peer-educator-based network.
Who it may be relevant to
Registry conditions: HIV Infections, Substance Use Disorders, Addiction, Opioid Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • Behavioral 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.

Primary outcome measures

  • Proportion of HIV testing for Network Members [Time frame: 3 months, 9-months]
Secondary outcome measures (6)
  • Proportion of HIV testing for Index and Network Members [Time frame: 3- and 9-month follow-up]
  • Proportion of HIV testing for Index Members [Time frame: 3- and 9-month follow-up]
  • Proportion of HIV negative participants who have used PrEP [Time frame: 3- and 9-month follow-up]
  • Change in Knowledge of PrEP options [Time frame: 3- and 9-month follow-up]
  • Proportion of participants using anti-retroviral therapy (ART) [Time frame: 3- and 9-month follow-up]
  • Proportion of participants who have used Medication for opioid use disorder (MOUD) uptake [Time frame: 3- and 9-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 2 centers
  • Johns Hopkins Hospital — Baltimore
  • Frederick County Health Department, Street Safe Program — Frederick

Identifiers

NCT: NCT06103370 · IRB00374291 · R01DA058387

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗