Drug Abuse, IntravenousNCT05794984
Telemedicine and Social Media for People Who Inject Drugs (PWID) in Greece
An observational study of Drug Abuse, Intravenous and Internet, run by State University of New York at Buffalo at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Abuse, Intravenous, Internet, Social Media
- What is being tested?
- Focus group discussions and survey questionnaire
- How many people
- 219 participants
- Where
- 1 siteGreece
- Study dates
- 2 May 2023to 18 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
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
Who may be able to join
- >18 years old
- PWID
- Willing and able to provide informed consent and participate
- Fluent in Greek spoken language
- Internet access
- >18 years old
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Drug Abuse, Intravenous, Internet, Social Media, Telemedicine
- Being tested
- Focus group discussions and survey questionnaire
- Medical subject headings
- Substance Abuse, Intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group discussions and survey questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Focus Group Discussions and Cross-sectional questionnaire | 57 people for targeted Focus Group Discussions 162 people for Cross-sectional questionnaire Receives: Other: Focus group discussions and survey questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start2 May 2023
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Drug Abuse, IntravenousStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases
- Responsible party
- Principal investigator, Andrew Talal, State University of New York at Buffalo
- Investigators
- Andrew Talal, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794984
- Sponsor's protocol ID
- STUDY00007088
- Status last verified
- Feb 2024
- First submitted
- 20 Mar 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30329042Talal 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.
PubMed 30325701Talal 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.
PubMed 34813962Talal 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.
PubMed 35925809Hatzakis 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.
PubMed 26032121Sypsa 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.
PubMed 28407106Papalamprakopoulou Z, Roussos S, Ntagianta E, Triantafyllou V, Kalamitsis G, Dharia A, Sypsa V, Hatzakis A, Talal AH. Considerations for equitable distribution of digital healthcare for people who use drugs. BMC Health Serv Res. 2025 Apr 10;25(1):531. doi: 10.1186/s12913-025-12619-7.
PubMed 40211324Papalamprakopoulou Z, Ntagianta E, Triantafyllou V, Kalamitsis G, Dharia A, Dickerson SS, Hatzakis A, Talal AH. Breaking the vicious cycle of delayed healthcare seeking for people who use drugs. Harm Reduct J. 2025 Mar 5;22(1):27. doi: 10.1186/s12954-025-01166-3.
PubMed 40045378Papalamprakopoulou Z, Ntagianta E, Triantafyllou V, Kalamitsis G, Dharia A, Dickerson SS, Hatzakis A, Talal AH. Telehealth to increase healthcare access; perspectives of people who use drugs. BMC Med Inform Decis Mak. 2024 Oct 19;24(1):306. doi: 10.1186/s12911-024-02718-6.
PubMed 39425182
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05794984
- Acronym / sponsor ID
- STUDY00007088
- Conditions
- Drug Abuse, Intravenous, Internet, Social Media, Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Hellenic Scientific Society for the Study of AIDS, Sexually Transmitted and Emerging Diseases
- Study start
- 2 May 2023 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 3 Apr 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Focus Group Discussions and Cross-sectional questionnaire | – | Other: Focus group discussions and survey questionnaire57 people for targeted Focus Group Discussions 162 people for Cross-sectional questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (13 listed)
- >18 years old
- PWID
- Willing and able to provide informed consent and participate
- Fluent in Greek spoken language
- Internet access
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Focus group discussions and survey questionnaireQuestions 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. | Other | Targeted Focus Group Discussions and Cross-sectional questionnaire |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 30329042Talal 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.
- Background: PubMed 30325701Talal 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.
- Background: PubMed 34813962Talal 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.
- Background: PubMed 35925809Talal 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.
- Background: PubMed 26032121Hatzakis 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.
- Background: PubMed 28407106Sypsa 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.
- Derived from this study: PubMed 40211324Papalamprakopoulou Z, Roussos S, Ntagianta E, Triantafyllou V, Kalamitsis G, Dharia A, Sypsa V, Hatzakis A, Talal AH. Considerations for equitable distribution of digital healthcare for people who use drugs. BMC Health Serv Res. 2025 Apr 10;25(1):531. doi: 10.1186/s12913-025-12619-7.
- Derived from this study: PubMed 40045378Papalamprakopoulou Z, Ntagianta E, Triantafyllou V, Kalamitsis G, Dharia A, Dickerson SS, Hatzakis A, Talal AH. Breaking the vicious cycle of delayed healthcare seeking for people who use drugs. Harm Reduct J. 2025 Mar 5;22(1):27. doi: 10.1186/s12954-025-01166-3.
- Derived from this study: PubMed 39425182Papalamprakopoulou Z, Ntagianta E, Triantafyllou V, Kalamitsis G, Dharia A, Dickerson SS, Hatzakis A, Talal AH. Telehealth to increase healthcare access; perspectives of people who use drugs. BMC Med Inform Decis Mak. 2024 Oct 19;24(1):306. doi: 10.1186/s12911-024-02718-6.
- Extensions of Respondent-Driven Sampling: Analyzing Continuous Variables and Controlling for Differential RecruitmentLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Andrew Talal, MD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Abuse, Intravenous and Internet, run by State University of New York at Buffalo at 1 site in Greece.
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 13 inclusion and 0 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: finished, as of the sponsor's last update on 5 Feb 2024. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05794984, which also lists 9 linked publications.
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 5 Feb 2024.