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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06103370
• Other study ID #: IRB00374291
• Secondary ID: R01DA058387
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: November 2028

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: Oluwaseun Falade-Nwulia, MBBS, MPH
• Phone: 410-550-6234
• Email: ofalade1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: November 2028
• Est. primary completion date: November 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Drug Use
• HIV Infections
• Intravenous Drug Usage
• Opioid Use
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	Maryland Department of Health and Mental Hygiene, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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