COVID-19NCT05769023
A Spatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs
A study testing Intervention test in people with COVID-19, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
Conduct a study of people who use drugs (PWUD) perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Intervention test
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- opioid use in prior 2 weeks
Who cannot join
- none
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
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: A Spatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland, Supplement
Conduct a study of people who use drugs (PWUD) perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers
Read the detailed description
Conduct a qualitative rapid longitudinal assessment of 20 PWUD's perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers. The investigators will also assess frequency and content of COVID-19 communication with peers. The investigators will also assess changes in the social network dynamics of drug use and access to illicit drugs, drug treatment, and HIV care. The brief qualitative interviews will be conducted biweekly over a period of one year. These interviews will be quickly transcribed, summarized, and provided to local and state health departments. The investigators will also use the findings from this aim to inform the proposed app and peer education pilot outlined in aims 2 \& 3.
- Development of an app provide real-time information on COVID-19 vaccine availability and nearby risk reduction resources (naloxone distribution sites, syringe exchanges, drug treatment). The app will be built for mobile download and as an online webpage. 20 PWUD will be included in this study component, split between the mobile and web-based app.
- Develop training materials and pilot the training of 40 PWUD to promote vaccine uptake among the participants network and other community members. PWUD will be trained to become peer educators to promote COVID-19 vaccine uptake over 4 sessions. These 40 participants will be administered pre- and post-surveys as well as daily check-in questions through the app to assess effectiveness as peer educators.
- Conditions
- COVID-19
- Being tested
- Intervention test
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention testBehavioural
behavioral sessions to promote vaccines
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | behavioral intervention Receives: Behavioral: Intervention test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine acceptance as assessed by the Oxford COVID-19 Vaccine Hesitancy Scale
Vaccine acceptance will be assessed using the Oxford COVID-19 Vaccine Hesitancy Scale, a seven-item scale that measures willingness to receive a COVID-19 vaccine. Scores ranged from 7 to 35, with higher scores indicating greater hesitancy.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Jan 2023
- 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 COVID-19Studies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot of an intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Carl Latkin, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769023
- Sponsor's protocol ID
- 5R01DA050470S1
- Other IDs
- IRB00019139, 5R01DA050470
- Status last verified
- May 2026
- First submitted
- 1 Mar 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: one year after study completion
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Spatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs in Baltimore, Maryland, Supplement
- ClinicalTrials.gov ID
- NCT05769023
- Acronym / sponsor ID
- 5R01DA050470S1
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 15 Mar 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.
Conduct a study of people who use drugs (PWUD) perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers
Detailed description
Conduct a qualitative rapid longitudinal assessment of 20 PWUD's perceptions of and access to COVID-19 vaccines as well as reasons for vaccine hesitancy/barriers. The investigators will also assess frequency and content of COVID-19 communication with peers. The investigators will also assess changes in the social network dynamics of drug use and access to illicit drugs, drug treatment, and HIV care. The brief qualitative interviews will be conducted biweekly over a period of one year. These interviews will be quickly transcribed, summarized, and provided to local and state health departments. The investigators will also use the findings from this aim to inform the proposed app and peer education pilot outlined in aims 2 \& 3.
- Development of an app provide real-time information on COVID-19 vaccine availability and nearby risk reduction resources (naloxone distribution sites, syringe exchanges, drug treatment). The app will be built for mobile download and as an online webpage. 20 PWUD will be included in this study component, split between the mobile and web-based app.
- Develop training materials and pilot the training of 40 PWUD to promote vaccine uptake among the participants network and other community members. PWUD will be trained to become peer educators to promote COVID-19 vaccine uptake over 4 sessions. These 40 participants will be administered pre- and post-surveys as well as daily check-in questions through the app to assess effectiveness as peer educators.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot of an intervention
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Intervention testbehavioral intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- opioid use in prior 2 weeks
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Intervention testbehavioral sessions to promote vaccines | Behavioural | Experimental |
Primary outcome
Vaccine acceptance as assessed by the Oxford COVID-19 Vaccine Hesitancy Scale
Time frame: 1 month
Vaccine acceptance will be assessed using the Oxford COVID-19 Vaccine Hesitancy Scale, a seven-item scale that measures willingness to receive a COVID-19 vaccine. Scores ranged from 7 to 35, with higher scores indicating greater hesitancy.
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 20 May 2026.
- Individual participant dataSharing planned: Yes. one year after study completion
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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 Intervention test in people with COVID-19, 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: enrolling by invitation, as of the sponsor's last update on 20 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine acceptance as assessed by the Oxford COVID-19 Vaccine Hesitancy Scale (time frame: 1 month). 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 20 May 2026.