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).

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infections; Addiction; Substance Use Disorders; Opioid Use; Drug Use; Intravenous Drug Usage
• Intervention / Treatment: Behavioral: Peer-educator-based network

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oluwaseun Falade-Nwulia, MBBS, MPH; Phone Number: 410-550-6234; Email: ofalade1@jhmi.edu
• Study Contact Backup: Name: Gregory Lucas, MD; Phone Number: 410-614-0560; Email: glucas@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of HIV testing for Index and Network Members	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).	3- and 9-month follow-up
Proportion of HIV testing for Index Members	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- and 9-month follow-up
Proportion of HIV negative participants who have used PrEP uptake	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.	3- and 9-month follow-up
Change in Knowledge of PrEP options	Knowledge of PrEP options and resources measured by questionnaire at 3 and 9 months among Network Members.	3- and 9-month follow-up
Proportion of participants using anti-retroviral therapy (ART)	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.	3- and 9-month follow-up
Proportion of participants who have used Medication for opioid use disorder (MOUD) uptake	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.	3- and 9-month follow-up

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA); Maryland Department of Health and Mental Hygiene
• Investigators: Principal Investigator: Oluwaseun Falade-Nwulia, MBBS, MPH, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: HIV Prevention; Social Networks; Injection Drug Use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: IRB00374291; R01DA058387 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No