A Spatial Analysis of Hotspots and Targeted Injection Settings Pilot Intervention for HIV Prevention Among People Who Inject Drugs

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

2. 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.

3. 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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Bloomberg School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • opioid use in prior 2 weeks

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
behavioral intervention
behavioral sessions to promote vaccines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Carl Latkin, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 5R01DA050470S1
  • 5R01DA050470 (U.S. NIH Grant/Contract)
  • IRB00019139 (Other Identifier: JHSPH IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

one year after study completion

IPD Sharing Time Frame

1 year

IPD Sharing Access Criteria

researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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