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

Johns Hopkins University

Status: Enrolling

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

Treatments: Behavioral: Peer-educator-based network

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06103370

R01DA058387 (U.S. NIH Grant/Contract)

IRB00374291

Details and patient eligibility

About

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).

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Peer-educator-based network intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Peer-educator-based network

Equal-attention control

No Intervention group

Description:

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.