HIV InfectionsNCT06103370
Syringe Service Based Telemedicine and Social Network Driven HIV Prevention Service Implementation
A study testing Peer-educator-based network in people with HIV Infections and Substance Use Disorders, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Substance Use Disorders, Addiction
- What is being tested?
- Peer-educator-based network
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- Not previously enrolled in the study as index or NM
- English-speaking
- 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
Who cannot join
- Individuals lacking the capacity to consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Recruiting
Frederick County Health Department, Street Safe Program
Frederick, Maryland, 21701
Marisa Shields, 301-600-1777, MShields@FrederickCountyMD.gov
About this study
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).
- Conditions
- HIV Infections, Substance Use Disorders, Addiction, Opioid Use, Drug Use, Intravenous Drug Usage
- Being tested
- Peer-educator-based network
- Keywords
- Injection Drug Use, HIV Prevention, Social Networks
- Medical subject headings
- HIV Infections, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-educator-based networkBehavioural
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 group | Role | What they receive |
|---|---|---|
| Peer-educator-based network intervention | Experimental | 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). Receives: Behavioral: Peer-educator-based network |
| Equal-attention control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months, 9-months
Secondary outcomes (6)
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).
Measured: 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).
Measured: 3- and 9-month follow-up
Proportion of HIV negative participants who have used PrEP
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3- and 9-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start28 Oct 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Maryland Department of Health and Mental Hygiene
- Responsible party
- Sponsor
- Investigators
- Oluwaseun Falade-Nwulia, MBBS, MPH, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103370
- Sponsor's protocol ID
- IRB00374291
- Other IDs
- R01DA058387
- Status last verified
- Nov 2025
- First submitted
- 23 Oct 2023
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syringe Service Based Telemedicine and Social Network Driven HIV Prevention Service Implementation
- ClinicalTrials.gov ID
- NCT06103370
- Acronym / sponsor ID
- IRB00374291
- Conditions
- HIV Infections, Substance Use Disorders, Addiction, Opioid Use, Drug Use, Intravenous Drug Usage
- Keywords
- Injection Drug Use, HIV Prevention, Social Networks
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Maryland Department of Health and Mental Hygiene
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-educator-based network intervention | Experimental | Behavioral: Peer-educator-based networkIndexes 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). |
| Equal-attention control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals lacking the capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-educator-based networkThe 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. | Behavioural | Peer-educator-based network intervention |
Primary outcome
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).
6 secondary outcomes
Proportion of HIV testing for Index and Network Members
Time frame: 3- and 9-month follow-up
Proportion of HIV testing for Index Members
Time frame: 3- and 9-month follow-up
Proportion of HIV negative participants who have used PrEP
Time frame: 3- and 9-month follow-up
Change in Knowledge of PrEP options
Time frame: 3- and 9-month follow-up
Proportion of participants using anti-retroviral therapy (ART)
Time frame: 3- and 9-month follow-up
Proportion of participants who have used Medication for opioid use disorder (MOUD) uptake
Time frame: 3- and 9-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oluwaseun Falade-Nwulia, MBBS, MPH principal investigator
Johns Hopkins School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-educator-based network in people with HIV Infections and Substance Use Disorders, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oluwaseun Falade-Nwulia, MBBS, MPH (410-550-6234, ofalade1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of HIV testing for Network Members (time frame: 3 months, 9-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.