HIV InfectionsOasisNCT05320835
A Setting Focus Overdose Prevention Intervention
A study testing HIV, HCV and overdose prevention in people with HIV Infections and HCV, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, HCV, Drug Overdose
- What is being tested?
- HIV, HCV and overdose prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2022to 30 May 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current drug user (opioid use in the prior two weeks)
Who cannot join
- Any mental or physical health impairment that impedes ability to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lighthouse Studies at Peer Point
Baltimore, Maryland, 21205
Carl Latkin, PhD, 410-502-5368, carl.latkin@jhu.edu
Melissa Davey-Rothwell, PhD, 410-614-5854, mdavey1@jhu.edu
About this study
Official title: A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland
A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).
Read the detailed description
This is a pilot of an injection setting targeted peer-driven intervention to reduce HIV/HCV transmission and overdose risk behaviors. Participants will be randomized to conditions: 1) Peer education and stocking of semi-public injection settings (SPIS) with risk reduction materials, and the standard of care. Based on their SPIS use, 120 index PWID participants will be selected.
A conceptual model for the intervention: The conceptual model is based on social influence, social network, and social cognitive theory. The prior work delineated social influence mechanisms. It is expected that training and modeling of effective communication skills will increase the occurrence of conversations on HIV/HCV and overdose prevention. These conversations will then alter perceived descriptive and prescriptive social norms of risk behaviors. The prior work is being enhanced by increasing the availability of risk reduction materials as well as the cuing and modeling risk reduction behaviors in risk settings. It has been found that PWID are motivated to conduct peer education; it enhances their status and provides them a prosocial role in the community. It is hypothesized that peer outreach and supply of materials to SPIS will lead to reduced sharing of injection equipment and increased naloxone availability.
- Conditions
- HIV Infections, HCV, Drug Overdose
- Being tested
- HIV, HCV and overdose prevention
- Medical subject headings
- HIV Infections, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV, HCV and overdose preventionBehavioural
HIV, HCV and overdose prevention
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | behavioral training with 6 sessions Receives: Behavioral: HIV, HCV and overdose prevention |
| comparison | Active comparator | Attention control Receives: Behavioral: HIV, HCV and overdose prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overdose prevention
Frequency of carrying naloxone
Measured: 6 months
HIV/HCV prevention
Frequency of using used cookers
Measured: 6 months
Secondary outcomes (2)
Overdose behaviors
Frequency of testing drugs before using
Measured: 6 months
Overdose behaviors 2
Frequency of talking about overdose prevention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start30 Apr 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion30 May 2027 (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.
- 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
- Model description
- Randomized Clinical Trial (RCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Carl Latkin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320835
- Sponsor's protocol ID
- R01DA050470
- Other IDs
- IRB00019139, R01DA050470
- Acronym
- Oasis
- Status last verified
- May 2026
- First submitted
- 30 Mar 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Geospatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland
- ClinicalTrials.gov ID
- NCT05320835
- Acronym / sponsor ID
- Oasis / R01DA050470
- Conditions
- HIV Infections, HCV, Drug Overdose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 11 Apr 2022 (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.
A pilot injection-setting targeted peer-driven intervention to reduce HIV and hepatitis C virus transmission and overdose risk behaviors among people who inject drugs (PWID).
Detailed description
This is a pilot of an injection setting targeted peer-driven intervention to reduce HIV/HCV transmission and overdose risk behaviors. Participants will be randomized to conditions: 1) Peer education and stocking of semi-public injection settings (SPIS) with risk reduction materials, and the standard of care. Based on their SPIS use, 120 index PWID participants will be selected.
A conceptual model for the intervention: The conceptual model is based on social influence, social network, and social cognitive theory. The prior work delineated social influence mechanisms. It is expected that training and modeling of effective communication skills will increase the occurrence of conversations on HIV/HCV and overdose prevention. These conversations will then alter perceived descriptive and prescriptive social norms of risk behaviors. The prior work is being enhanced by increasing the availability of risk reduction materials as well as the cuing and modeling risk reduction behaviors in risk settings. It has been found that PWID are motivated to conduct peer education; it enhances their status and provides them a prosocial role in the community. It is hypothesized that peer outreach and supply of materials to SPIS will lead to reduced sharing of injection equipment and increased naloxone availability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: HIV, HCV and overdose preventionbehavioral training with 6 sessions |
| comparison | Active comparator | Behavioral: HIV, HCV and overdose preventionAttention control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current drug user (opioid use in the prior two weeks)
Key exclusion criteria (1 listed)
- Any mental or physical health impairment that impedes ability to participate
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 |
|---|---|---|
| HIV, HCV and overdose preventionHIV, HCV and overdose prevention | Behavioural | Experimental, comparison |
Primary outcome
Overdose prevention
Time frame: 6 months
Frequency of carrying naloxone
HIV/HCV prevention
Time frame: 6 months
Frequency of using used cookers
2 secondary outcomes
Overdose behaviors
Time frame: 6 months
Overdose behaviors 2
Time frame: 6 months
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 22 May 2026.
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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.
Carl Latkin, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV, HCV and overdose prevention in people with HIV Infections and HCV, run by Johns Hopkins Bloomberg School of Public Health at 1 site 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 1 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Carl Latkin, PhD (410-955-3972, carl.latkin@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overdose prevention (time frame: 6 months). The study lists 2 primary outcomes in all. 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 22 May 2026.