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

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

Tracking Information
First Submitted Date  ICMJE October 23, 2023
First Posted Date  ICMJE October 26, 2023
Last Update Posted Date October 26, 2023
Estimated Study Start Date  ICMJE August 2024
Estimated Primary Completion Date November 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2023)		 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2023)
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Syringe Service Based Telemedicine and Social Network Driven HIV Prevention Service Implementation
Official Title  ICMJE Syringe Service Based Telemedicine and Social Network Driven HIV Prevention Service Implementation
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HIV Infections
  • Substance Use Disorders
  • Addiction
  • Opioid Use
  • Drug Use
  • Intravenous Drug Usage
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: Peer-educator-based network
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2023)		 360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2028
Estimated Primary Completion Date November 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Oluwaseun Falade-Nwulia, MBBS, MPH 410-550-6234 ofalade1@jhmi.edu
Contact: Gregory Lucas, MD 410-614-0560 glucas@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06103370
Other Study ID Numbers  ICMJE IRB00374291
R01DA058387 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Johns Hopkins University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johns Hopkins University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Maryland Department of Health and Mental Hygiene
Investigators  ICMJE
Principal Investigator: Oluwaseun Falade-Nwulia, MBBS, MPH Johns Hopkins School of Medicine
PRS Account Johns Hopkins University
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP