Drug UseNCT04099719
Geographical Information System (GIS) Mapping to Assess the Need for IEP Provision in Tayside
An observational study of Drug Use, run by NHS Tayside at 1 site in United Kingdom.
Trial summary
The aim of this study is to review the current provision of IEP services provided across Tayside and consider to what extent they are contributing to keeping this vulnerable population safe. The study will look at the coverage provided by the current service and map this against the known harms e.g. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Drug Use
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 31 Oct 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Anyone (>16 years old) registered with services providing drug treatment and harm reduction activities in Tayside
Who may be able to join
- Anyone (>16 years old) registered with services providing drug treatment and harm reduction activities in Tayside Retrospective data from the identified databases which identifies 4 digit postcode unit of residence. All activity will be included regardless of patient characteristics.
- Data will be gathered retrospectively from the past year.
Who cannot join
- Data that does not identify 4 digit postcode unit of residence
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Directorate of Public Health
Dundee, Tayside, DD3 8EA
About this study
Official title: A GIS Mapping Exercise to Assess the Need for Injecting Equipment Provision (IEP) Services and Overdose Prevention Activities in Tayside.
The aim of this study is to review the current provision of IEP services provided across Tayside and consider to what extent they are contributing to keeping this vulnerable population safe. The study will look at the coverage provided by the current service and map this against the known harms e.g. drugs litter finds, incidences of non-fatal overdoses and drug related deaths. This mapping process will then allow recommendations to be made in a strategic way to advise future service delivery plans to ensure that services are delivered that are reachable to the communities that need these valuable services.
Read the detailed description
People who inject drugs (PWIDs) do so at significant risk to themselves due to transmission of blood borne viruses (BBV), injecting injuries, bacterial infections and drug related deaths.
NHS Tayside has a responsibility for improving the health of the population. PWIDs represent a particularly vulnerable group who experience significant health inequalities as well as stigmatisation and discriminatory attitudes.
Injecting Equipment Provision (IEP) services contribute to a reduction in BBV transmission through the provision of free sterile equipment for each injection. IEP services also provide advice on good injecting technique to avoid injecting injuries and bacterial infections. Crucially they can also provide "take home naloxone". Intramuscular injection of naloxone is a first aid emergency response for potentially fatal opiate overdoses and provides more time for emergency services to attend. Supplies of "take home naloxone" are made, along with training on overdose awareness, to those individuals at risk of opioid overdose in order to reduce the risk of fatality.
IEP services contribute to a reduction in drug related deaths by engaging with those thought to be most at risk, either through poly substance use or those who are not engaged with other services
The aim of this study is to review the current provision of IEP services provided across Tayside and consider to what extent they are contributing to keeping this vulnerable population safe. The study will look at the coverage provided by the current service and map this against the known harms e.g. drugs litter finds, incidences of non-fatal overdoses and drug related deaths. This mapping process will then allow recommendations to be made in a strategic way to advise future service delivery plans to ensure that services are delivered that are reachable to the communities that need these valuable services.
The protocol has been peer reviewed by the expert working group established to review the current provision of IEP and harm reduction and overdose awareness services across Tayside
Individual consent from patients will not be sought. The data provided by the databases will be retrospective 4 digit postcode data and will not include patient identifiable information. The data obtained will not be used in any way which may influence the care of the patient.
Data collection methods will not identify individual patients.
Researchers will be accessing information from databases which they have access to as part of their routine work. Information will remain anonymous and patient confidentiality will be upheld.
Separate consents will be sought to allow council colleagues to provide information on drug litter finds.
Anonymous 4 digit postcode data will be transferred onto Geographic Information System (GIS) maps to demonstrate coverage of services mapped against known harms (non-fatal overdoses, drug related deaths and drug litter finds). GIS maps do not identify individual postcodes.
The GIS maps will be used to identify gaps in the provision of services and provide an evidence base behind recommendations to improve service provision.
- Conditions
- Drug Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anyone (>16 years old) registered with services providing drug | retrospective data, no intervention to be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
GIS mapping of IEP and overdose prevention activity across Tayside
number and 4 digit postcode location of individuals accessing IEP services, receiving Opiate Substitution Therapy from Community Pharmacy, Number and 4 digit postcode location of naloxone kits distributed, number and 4 digit postcode location of drug deaths, number and 4 digit postcode location of non fatal overdoses, number and location of drug litter finds.
Measured: 1 year
Secondary outcomes (6)
Construct a GIS map of the coverage of each community pharmacy in Tayside for Opiate Substitution Therapy (OST) dispensing
4 digit postcodes of OST prescriptions from Controlled Drug database for each community pharmacy
Measured: 1 year
Construct a GIS map of the coverage of each IEP site in Tayside
4 digit postcodes of those accessing IEP sites recorded on NEO database
Measured: 1 year
Construct a GIS map of Drug litter finds e.g. discarded needles reported to council colleagues for safe disposal
Postcode of locations of drug litter finds
Measured: 1 year
Non-fatal overdoses mapped onto a HEAT map.
4 digit postcode of patients experiencing Non-fatal overdoses (NFOD) from NFOD database
Measured: 1 year
Drug deaths mapped onto a HEAT map
4 digit postcode of those lost to Drug Deaths from Drug Death database
Measured: 1 year
Take Home Naloxone supply data mapped
4 digit postcode information for people supplied naloxone on naloxone database
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Jul 2019
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UseStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sarah Donaldson, NHS Tayside
- Investigators
- Sarah R Donaldson, MRPharmS, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099719
- Sponsor's protocol ID
- 3-010-18
- Status last verified
- Dec 2019
- First submitted
- 4 Jul 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A GIS Mapping Exercise to Assess the Need for Injecting Equipment Provision (IEP) Services and Overdose Prevention Activities in Tayside.
- ClinicalTrials.gov ID
- NCT04099719
- Acronym / sponsor ID
- 3-010-18
- Conditions
- Drug Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 23 Sep 2019 (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 aim of this study is to review the current provision of IEP services provided across Tayside and consider to what extent they are contributing to keeping this vulnerable population safe. The study will look at the coverage provided by the current service and map this against the known harms e.g. drugs litter finds, incidences of non-fatal overdoses and drug related deaths. This mapping process will then allow recommendations to be made in a strategic way to advise future service delivery plans to ensure that services are delivered that are reachable to the communities that need these valuable services.
Detailed description
People who inject drugs (PWIDs) do so at significant risk to themselves due to transmission of blood borne viruses (BBV), injecting injuries, bacterial infections and drug related deaths.
NHS Tayside has a responsibility for improving the health of the population. PWIDs represent a particularly vulnerable group who experience significant health inequalities as well as stigmatisation and discriminatory attitudes.
Injecting Equipment Provision (IEP) services contribute to a reduction in BBV transmission through the provision of free sterile equipment for each injection. IEP services also provide advice on good injecting technique to avoid injecting injuries and bacterial infections. Crucially they can also provide "take home naloxone". Intramuscular injection of naloxone is a first aid emergency response for potentially fatal opiate overdoses and provides more time for emergency services to attend. Supplies of "take home naloxone" are made, along with training on overdose awareness, to those individuals at risk of opioid overdose in order to reduce the risk of fatality.
IEP services contribute to a reduction in drug related deaths by engaging with those thought to be most at risk, either through poly substance use or those who are not engaged with other services
The aim of this study is to review the current provision of IEP services provided across Tayside and consider to what extent they are contributing to keeping this vulnerable population safe. The study will look at the coverage provided by the current service and map this against the known harms e.g. drugs litter finds, incidences of non-fatal overdoses and drug related deaths. This mapping process will then allow recommendations to be made in a strategic way to advise future service delivery plans to ensure that services are delivered that are reachable to the communities that need these valuable services.
The protocol has been peer reviewed by the expert working group established to review the current provision of IEP and harm reduction and overdose awareness services across Tayside
Individual consent from patients will not be sought. The data provided by the databases will be retrospective 4 digit postcode data and will not include patient identifiable information. The data obtained will not be used in any way which may influence the care of the patient.
Data collection methods will not identify individual patients.
Researchers will be accessing information from databases which they have access to as part of their routine work. Information will remain anonymous and patient confidentiality will be upheld.
Separate consents will be sought to allow council colleagues to provide information on drug litter finds.
Anonymous 4 digit postcode data will be transferred onto Geographic Information System (GIS) maps to demonstrate coverage of services mapped against known harms (non-fatal overdoses, drug related deaths and drug litter finds). GIS maps do not identify individual postcodes.
The GIS maps will be used to identify gaps in the provision of services and provide an evidence base behind recommendations to improve service provision.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anyone (>16 years old) registered with services providing drug | – | –retrospective data, no intervention to be administered |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Anyone (>16 years old) registered with services providing drug treatment and harm reduction activities in Tayside
Key inclusion criteria (2 listed)
- Anyone (>16 years old) registered with services providing drug treatment and harm reduction activities in Tayside Retrospective data from the identified databases which identifies 4 digit postcode unit of residence. All activity will be included regardless of patient characteristics.
- Data will be gathered retrospectively from the past year.
Key exclusion criteria (1 listed)
- Data that does not identify 4 digit postcode unit of residence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GIS mapping of IEP and overdose prevention activity across Tayside
Time frame: 1 year
number and 4 digit postcode location of individuals accessing IEP services, receiving Opiate Substitution Therapy from Community Pharmacy, Number and 4 digit postcode location of naloxone kits distributed, number and 4 digit postcode location of drug deaths, number and 4 digit postcode location of non fatal overdoses, number and location of drug litter finds.
6 secondary outcomes
Construct a GIS map of the coverage of each community pharmacy in Tayside for Opiate Substitution Therapy (OST) dispensing
Time frame: 1 year
Construct a GIS map of the coverage of each IEP site in Tayside
Time frame: 1 year
Construct a GIS map of Drug litter finds e.g. discarded needles reported to council colleagues for safe disposal
Time frame: 1 year
Non-fatal overdoses mapped onto a HEAT map.
Time frame: 1 year
Drug deaths mapped onto a HEAT map
Time frame: 1 year
Take Home Naloxone supply data mapped
Time frame: 1 year
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 18 Dec 2019.
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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.
Sarah R Donaldson, MRPharmS principal investigator
NHS Tayside
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 Use, 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 2 inclusion and 1 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 18 Dec 2019. 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?
GIS mapping of IEP and overdose prevention activity across Tayside (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2019; AzTrials last refreshed its copy on 31 Oct 2026.