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Hepatitis CNCT03697135

Ask a Friend to Take a Test for Hepatitis C Infection

An observational study of Hepatitis C, run by NHS Tayside at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This exploratory study will carry out a respondent-driven sampling exercise, where participants will identify their previous injecting partners and contact these individuals to invite them to take an Hepatitis C test. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hepatitis C
What is being tested?
Respondent Driven Sampling
How many people
51 participants
Where
1 siteUnited Kingdom
Study dates
1 Sep 2018to 30 Dec 2019
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Injecting partners of people who use drugs

Who may be able to join

  • Previous or current history of injecting drug use
  • Able to provide informed consent
  • Willing to identify previous injecting partners (people they have injected with)
  • Willing to undergo training on approaching previous injecting partners according to the study proceduresWilling to contact previous injecting partners according to the study proceduresAged 18 and over

Who cannot join

  • No previous history of injecting drug use
  • Not willing to provide informed consentNot willing to participate in the procedures required in the study protocol.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Ninewells Hospital

    Dundee, Tayside, DD1 9SY

Other trials in United Kingdom

About this study

Official title: A Respondent Driven Sampling Study to Identify the Hidden Population of Former Intravenous Drug Users With Hepatitis C Infection Who Are no Longer in Contact With Services. "Ask a Friend"

This exploratory study will carry out a respondent-driven sampling exercise, where participants will identify their previous injecting partners and contact these individuals to invite them to take an Hepatitis C test. The data from participants about their injecting network will be used to construct a social network map (egonet) of the interlinking injecting networks. The numbers of individuals identified in the injecting networks will be used to estimate the size of the injecting population in Dundee. Participants will be interviewed to find out how they felt about the processes used.

Read the detailed description

Initial seed participants (25 individuals) will be identified from local support organisations who work with drug users, by members of the research team. Members of the research team will identify seeds from the Cairn Centre initially and sequentially visit partner organisations as the study proceeds. Seed participants will be current or former injecting drug users who are in contact with services. Seed participants will be provided with the study information sheet (PIS, participant information sheet) and asked to provide consent to take part in the study, according to standard practice. All members of the research team are trained in study procedures and Good Clinical Practice Seed participants will be requested to identify members of their previous injecting network by providing general information about these individuals to create a pseudo-identity. They may be assisted in doing this by the use of a mapping tool. The researchers will collect a standard dataset: Given name; approximate age; approximate area of town/city (if known); Ethnicity; Strength of tie (How often they injected with this person - Likert scale, year first and last injected with). The pseudo-identities created by the seeds will be insufficient to identify an actual person, but will enable the seed participant to focus on who they might like to contact. The actual identities of the person they contact will only be known to the researchers when this person presents for testing and consents to participation.

Advice will be given to the seed participants about sensitively approaching individuals who they used to inject with and about how people who are approached by them can access HCV testing. The data from identified contacts will be recorded onto an Excel Spreadsheet held on a password-protected computer within a locked office at the University of Dundee. These data will be utilised to construct an egomap using a computer programme designed for this purpose such as "Egonet". However it should be noted that the identified contacts are "pseudo identities" since the details do not correspond to a real person until they come forward for testing and can be linked to a CHI number.

Seed participants will have the study coupon system explained to them, which they will use to invite injecting partners to take an HCV test. Each study coupon will contain a unique reference number that links it to the individual who gave the former IDU the invitation. The participants will be handed sufficient coupons to cover the number of alters identified by them, up to a maximum of 5 coupons at one time. The seed participants will be issued with study information cards and study coupons to enable them to invite their contacts to present for an HCV test. The former drug users identified by seeds represent wave 1 of the respondent-driven sample. The respondent driven sampling will be managed with standard software (RDSAT). If seeds only identify contacts known to services, then this will be recorded and the participant's social network logged.

Seed participants will be contacted weekly by phone or when they are visiting the Cairn Centre for up to 4 weeks, by a designated member of the research team to ask about progress in contacting social network contacts. The contact will be recorded on a log sheet that will enable a summary of the conversation to be recorded The study will initially offer Dried Blood Spot Testing (DBST) through the Cairn Centre in Dundee, where the study methods will be first piloted. Individuals who wish to be tested will contact the Cairn Centre using the telephone number included on the coupon and make an arrangement to be tested. All testing will be done according to the standard operating procedures and guidance prepared by the Sexual Health and Blood Borne Virus Managed Care Network.

As the study proceeds, additional sites will be visited by the research team and additional seeds identified and invited to participate if required. These additional sites are already in use by the intended participant groups as community hubs and community pharmacies in Dundee at Lochee, Hilltown, Albert Street and Menzieshill. At this stage, potential participants may be approached by the care team (community/pharmacy) only who will introduce the research team to potential participants When the potential wave 1 study participant (who is a contact identified by the seed participant) contacts the Cairn Centre about a DBST, all relevant details to enable their clinical care will be recorded by the member of the specialist nurse, who works in the Cairn Centre, to enable the results of the test to be communicated to the participant and advice on any future care and treatment provided. The information collected will be sufficient to enable a CHI number to be identified. The CHI number is an essential requirement to ensure that all participants who are tested can be informed of the test result and can access ongoing referral and treatment as appropriate. The processing of results and documentation in the clinical record will be undertaken by a research nurse attached to the HCV clinical team. The participant will be provided with information about the HCV test and its meaning and offered referral for treatment as NHS standard of care. In addition and making it clear this is an additional option the nurse will give a PIS, to advise them about the opportunity to join the study. Caldicott approvals will be gained for all appropriate data that will be collected At least 24 hours after they have received study information they will be asked if they will consent to participate in the study and then visit the Cairn Centre for a test. Wave 1 participants will be invited to provide standard information about people that they injected with, as described above, to enable an egomap to be constructed. The participant will be supported to complete a standard form containing the minimum dataset required to construct the egomap. The Standard dataset is: Name; approximate age; area of town/city; Ethnicity; Strength of tie (How often they injected with this person - Likert scale). Specialist nurses from the clinical team who work at the Cairn Centre will talk to Seeds about sensitively approaching individuals who they have discussed who they used to inject with and about how people who are approached can access HCV testing. The information collected will be used to identify how many potential contacts the participant has knowledge of and compared to the actual recruitment and to ascertain the relationships between one injecting network and an adjacent network.

The people handed coupons by the Wave 1 participants will constitute Wave 2 participants. When the wave 2 participant present for HCV testing, the person testing them will follow the same procedure as outlined above so that the participant can be advised of their test result and be referred for on-going care and treatment if required. The wave 2 participants will receive the same training and guidance as the wave one participants received. Study procedures regarding inclusion, exclusion and consent will be identical for each Wave.

Conditions
Hepatitis C
Being tested
Respondent Driven Sampling
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Respondent Driven SamplingBehavioural

    Participants are asked to invite contacts that they previously injected with to take a test for hepatitis C

Study groups in NCT03697135
Study groupRoleWhat they receive
Seed ContactsInitial participants who will invite previous injecting contacts to take a hepatitis C test using a respondent driven sampling method
Receives: Behavioral: Respondent Driven Sampling
Initial Nominations for TestingContacts of initial participants who consent to be tested and enrol in the study using a respondent driven sampling method
Receives: Behavioral: Respondent Driven Sampling
Second Level Nominations for testingContacts of wave one participants who consent to be tested and enrol in the study using a respondent driven sampling method
Receives: Behavioral: Respondent Driven Sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatitis C test

    Number of participants consenting to a Hepatitis C test by Dried Blood Spot

    Measured: baseline

Secondary outcomes (1)
  1. Process evaluation

    Qualitative interview with each participant using discussion guide agreed by ethics

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start1 Sep 2018
  3. Primary completion30 Dec 2019
  4. Study completion30 Dec 2019

Resources

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
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03697135
Sponsor's protocol ID
2016GA02
Status last verified
Jul 2020
First submitted
23 Mar 2018
Last updated
4 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Anonymised social network structures of a hepatitis C injecting network

Publications

  • Abdul-Quader AS, Heckathorn DD, McKnight C, Bramson H, Nemeth C, Sabin K, Gallagher K, Des Jarlais DC. Effectiveness of respondent-driven sampling for recruiting drug users in New York City: findings from a pilot study. J Urban Health. 2006 May;83(3):459-76. doi: 10.1007/s11524-006-9052-7.

    PubMed 16739048
  • Heckathorn DD, Semaan S, Broadhead RS, Hughes JJ. Extensions of respondent-driven sampling: a new approach to the study of injection drug users aged 18-25. AIDS and Behavior. 2002;6(1):55-67.

  • Donaldson SR, Radley A, Dillon JF. Identifying the Hidden Population: Former Intravenous Drug Users Who Are No Longer in Contact with Services. "Ask a Friend". Diagnostics (Basel). 2021 Jan 25;11(2):170. doi: 10.3390/diagnostics11020170.

    PubMed 33504077

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, run by NHS Tayside at 1 site in United Kingdom.

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 4 inclusion and 2 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 4 Aug 2020. 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 United Kingdom. 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?

Hepatitis C test (time frame: baseline). 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 NCT03697135, which also lists 3 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 4 Aug 2020.

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Ask a Friend to Take a Test for Hepatitis C Infection | AzTrials