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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05794984
Other study ID # STUDY00007088
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2023
Est. completion date September 18, 2023

Study information

Verified date February 2024
Source State University of New York at Buffalo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 219
Est. completion date September 18, 2023
Est. primary completion date September 18, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Focus group discussions and survey 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.

Locations

Country Name City State
Greece Prometheus Athens

Sponsors (2)

Lead Sponsor Collaborator
State University of New York at Buffalo Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases

Country where clinical trial is conducted

Greece, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary There are not specific predetermined endpoints to be defined. 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.
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