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

• ClinicalTrials.gov Identifier: NCT06103370
• Recruitment Status: Not yet recruiting
• First Posted: October 26, 2023
• Last Update Posted: October 26, 2023
• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA); Maryland Department of Health and Mental Hygiene
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
HIV Infections; Substance Use Disorders; Addiction; Opioid Use; Drug Use; Intravenous Drug Usage	Behavioral: Peer-educator-based network	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Syringe Service Based Telemedicine and Social Network Driven HIV Prevention Service Implementation
• Estimated Study Start Date: August 2024
• Estimated Primary Completion Date: November 2028
• Estimated Study Completion Date: November 2028

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 uptake [ 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Oluwaseun Falade-Nwulia, MBBS, MPH; 410-550-6234; ofalade1@jhmi.edu

Contact: Gregory Lucas, MD; 410-614-0560; glucas@jhmi.edu

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

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

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT06103370
• Other Study ID Numbers: IRB00374291; R01DA058387 ( U.S. NIH Grant/Contract )
• First Posted: October 26, 2023
• Last Update Posted: October 26, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:

Injection Drug Use; HIV Prevention; Social Networks

Additional relevant MeSH terms:

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders