- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05794984
Telemedicine and Social Media for People Who Inject Drugs (PWID) in Greece
February 2, 2024 updated by: Andrew Talal, State University of New York at Buffalo
Targeted Focus Groups Discussions (FGDs) and Cross-sectional Questionnaire to Address Questions Regarding Telemedicine Concept and Knowledge, and Social Media Usage Among People Who Inject Drugs (PWID) in Greece
The current study seeks to address questions regarding internet and social media usage as well as telemedicine concept and knowledge, by conducting targeted focus group discussions (FGDs) and administering cross-sectional questionnaires among PWID in Greece.
Further parameters, such as perceptions for high-quality healthcare access, confidentiality, privacy, and security, will also be explored.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study's aim is to access the feasibility, acceptability and accessibility of social media and telemedicine as methods to obtain healthcare, in order to improve linkage-to-care among Greek substance users.
Underserved populations, such as people who inject drugs (PWID) have limited access to healthcare and a potential solution to expanding healthcare access points is telemedicine.
For the past decade, the investigators have studied the efficacy of a facilitated telemedicine model for hepatitis C virus (HCV) treatment integrated into opioid treatment programs (OTPs) for PWIDs.
The investigators have achieved high rates of HCV resolution and high patient-satisfaction through facilitated telemedicine.
The investigators now seek to explore whether this same intervention might be feasible and acceptable in Greece.
The first step is to capture and explore the current knowledge, experiences, believes, perceptions and attitudes of PWID in Greece regarding internet and social media usage and telemedicine concept, through targeted Focus Group Discussions (FGDs) and administration of cross-sectional questionnaire.
The perceptions for high-quality healthcare, confidentiality, privacy and security matters will also be explored as well as further relevant attributes.
Study Type
Observational
Enrollment (Actual)
219
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arpan Dharia, MD
- Phone Number: 716-829-3101
- Email: adharia@buffalo.edu
Study Locations
-
-
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Athens, Greece
- Prometheus
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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
N/A
Sampling Method
Non-Probability Sample
Study Population
PWID are a medically and socially vulnerable population with high incidence of overdose, mental illness and infections such as HIV and hepatitis C
Description
Inclusion Criteria for the FDGs:
- >18 years old
- PWID
- Willing and able to provide informed consent and participate
- Fluent in Greek spoken language
- Internet access
Inclusion Criteria for the cross-sectional questionnaire:
- >18 years old
- PWID
- Willing and able to provide informed consent and participate
- Fluent in Greek spoken language
Exclusion Criteria for FGD and cross-sectional questionnaire:
- <18 years old
- Unable/unwilling to consent
- Legally incompetent
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Targeted Focus Group Discussions and Cross-sectional questionnaire
57 people for targeted Focus Group Discussions 162 people for Cross-sectional questionnaire
|
Questions regarding internet and social media usage, as well as telemedicine concept and knowledge.
Assessment of the feasibility, acceptability and accessibility of social media and telemedicine as methods to obtain healthcare.
Perceptions for high-quality healthcare access, confidentiality, privacy, and security, will also be explored.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
There are not specific predetermined endpoints to be defined.
Time Frame: For the FGDs approximately up to 3-4 months is needed to enroll all study subjects. For the cross-sectional questionnaire approximately up to 6-8 months is needed to enroll all study subjects. Endpoints will be generated according to study's results.
|
This is a mixed methods study designed to assess the feasibility, acceptability, and accessibility of telemedicine and social media to improve healthcare access among Greek PWUD.
It is not an interventional trial.
The results of this study will be used to generate endpoints and sample sizes for a larger trial.
|
For the FGDs approximately up to 3-4 months is needed to enroll all study subjects. For the cross-sectional questionnaire approximately up to 6-8 months is needed to enroll all study subjects. Endpoints will be generated according to study's results.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew Talal, MD, University at Buffalo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hatzakis A, Sypsa V, Paraskevis D, Nikolopoulos G, Tsiara C, Micha K, Panopoulos A, Malliori M, Psichogiou M, Pharris A, Wiessing L, van de Laar M, Donoghoe M, Heckathorn DD, Friedman SR, Des Jarlais DC. Design and baseline findings of a large-scale rapid response to an HIV outbreak in people who inject drugs in Athens, Greece: the ARISTOTLE programme. Addiction. 2015 Sep;110(9):1453-67. doi: 10.1111/add.12999. Epub 2015 Jul 14.
- Talal AH, Andrews P, Mcleod A, Chen Y, Sylvester C, Markatou M, Brown LS. Integrated, Co-located, Telemedicine-based Treatment Approaches for Hepatitis C Virus Management in Opioid Use Disorder Patients on Methadone. Clin Infect Dis. 2019 Jul 2;69(2):323-331. doi: 10.1093/cid/ciy899.
- Talal AH, McLeod A, Andrews P, Nieves-McGrath H, Chen Y, Reynolds A, Sylvester C, Dickerson SS, Markatou M, Brown LS. Patient Reaction to Telemedicine for Clinical Management of Hepatitis C Virus Integrated into an Opioid Treatment Program. Telemed J E Health. 2019 Sep;25(9):791-801. doi: 10.1089/tmj.2018.0161. Epub 2018 Oct 16.
- Talal AH, Markatou M, Sofikitou EM, Brown LS, Perumalswami P, Dinani A, Tobin JN. Patient-centered HCV care via telemedicine for individuals on medication for opioid use disorder: Telemedicine for Evaluation, Adherence and Medication for Hepatitis C (TEAM-C). Contemp Clin Trials. 2022 Jan;112:106632. doi: 10.1016/j.cct.2021.106632. Epub 2021 Nov 20.
- Talal AH, Sofikitou EM, Wang K, Dickerson S, Jaanimagi U, Markatou M. High Satisfaction with Patient-Centered Telemedicine for Hepatitis C Virus Delivered to Substance Users: A Mixed-Methods Study. Telemed J E Health. 2023 Mar;29(3):395-407. doi: 10.1089/tmj.2022.0189. Epub 2022 Aug 4.
- Sypsa V, Psichogiou M, Paraskevis D, Nikolopoulos G, Tsiara C, Paraskeva D, Micha K, Malliori M, Pharris A, Wiessing L, Donoghoe M, Friedman S, Jarlais DD, Daikos G, Hatzakis A. Rapid Decline in HIV Incidence Among Persons Who Inject Drugs During a Fast-Track Combination Prevention Program After an HIV Outbreak in Athens. J Infect Dis. 2017 May 15;215(10):1496-1505. doi: 10.1093/infdis/jix100.
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)
May 2, 2023
Primary Completion (Actual)
September 18, 2023
Study Completion (Actual)
September 18, 2023
Study Registration Dates
First Submitted
March 20, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Estimated)
February 5, 2024
Last Update Submitted That Met QC Criteria
February 2, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007088
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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