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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05769023
Other study ID # 5R01DA050470S1
Secondary ID IRB000191395R01D
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date January 1, 2027

Study information

Verified date March 2024
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date January 1, 2027
Est. primary completion date January 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - opioid use in prior 2 weeks Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention test
behavioral sessions to promote vaccines

Locations

Country Name City State
United States Johns Hopkins Bloomberg School of Public Health Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month
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