Opioid-Related DisordersNCT05657106
Kentucky Outreach Service Kiosk (KyOSK): Reducing HIV, HCV, and Overdose Risk
A study testing Health kiosk in people with Opioid-Related Disorders and Hepatitis C (HCV), run by April M Young at 1 site in United States.
Trial summary
This study will test the effectiveness, implementation outcomes, and cost effectiveness of a locally-tailored, health kiosk to reduce overdose, hepatitis C, and HIV risk behavior and improve linkage to care in rural Appalachia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-Related Disorders, Hepatitis C (HCV), Human Immunodeficiency Virus (HIV)
- What is being tested?
- Health kiosk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Individuals are eligible if they are:
- age 18 or older,
- live in the intervention or comparison county, and
- have engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco).
Who cannot join
- Individuals are not eligible if they meet any of the exclusion criteria:
- being under the age of 18,
- not living in the intervention or comparison county,
- having not engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco),
- not being able to speak or understand English,
- conviction in the past 10 years of a violent crime (i.e., murder, manslaughter, rape, robbery, and /or aggravated assault) or stalking,
- current charges of violent crime or stalking, or
- having plans to move out of the study counties in the next 6 months, or residing in an inpatient facility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kentucky Outreach Service Kiosk (KyOSK): Addressing Health Needs and Improving Service Linkage in Rural Appalachia Through Health Kiosks
This study will test the effectiveness, implementation outcomes, and cost effectiveness of a locally-tailored, health kiosk to reduce overdose, hepatitis C, and HIV risk behavior and improve linkage to care in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of overdoses, hepatitis C, and injection-related infections.
Read the detailed description
This is a Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial to assess the impact of a community-tailored health kiosk on HIV, HCV, and overdose risk in rural Appalachia, and a mixed methods evaluation of implementation outcomes. The trial will compare the standard health department program (staffed, brick-and-mortar) to an enhanced model involving a health kiosk + standard health department program. The kiosk, referred to as the KyOSK (Kentucky Outreach Service Kiosk) will be tailored through a community-engaged adaptation process. For evaluation of the KyOSK, the investigators will enroll 750 People Who Use Drugs (PWUD) in the intervention (n=425) and comparison (n=325) counties, collectively referred to as the kiosk trial cohort. The kiosk trial cohort will be recruited from three sources: existing cohorts of PWUD, local agencies, and peer-referral. Throughout the trial and following the implementation outcome framework (IOF) measurement model by Proctor et al., acceptability, appropriateness, fidelity, cost, penetration, and sustainability will be assessed using a combination of validated scales, qualitative interviews, checklists, invoices, and program data. Following the trial, the investigators will use data collected from the kiosk cohort and implementation outcome assessment (primarily cost and reach) in a dynamic, deterministic model of HCV transmission and overdose to examine the impact and cost-effectiveness of the KyOSK model.
- Conditions
- Opioid-Related Disorders, Hepatitis C (HCV), Human Immunodeficiency Virus (HIV), Drug Overdose, Substance Abuse, Intravenous Drug Usage
- Being tested
- Health kiosk
- Medical subject headings
- Opioid-Related Disorders, Hepatitis C, Acquired Immunodeficiency Syndrome, Drug Overdose, Substance-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health kioskBehavioural
The intervention involves enhancing its existing health department model with a Kentucky Outreach Service Kiosk (KyOSK).
| Study group | Role | What they receive |
|---|---|---|
| Health Department Program Plus a Health Kiosk Intervention | Experimental | The intervention involves enhancing the health department's existing staffed model of service delivery with a KyOSK. The intervention county's staffed program operates identically to the comparison county. Both counties' staffed programs and the kiosk will use an identically structured unique ID to provide objective data on service engagement. The KyOSK will resemble a vending machine but with a touchscreen, audiovisual interface. The KyOSK will include naloxone, wound care kits, and supplies for basic needs (e.g., hygiene items, food, water, emergency blankets); offer overdose education materials; and an innovative call-back feature for care navigation by recovery coaches. While the KyOSK is operating, the county will continue to operate its traditional program. Receives: Behavioral: Health kiosk |
| Staffed Health Department Program | No intervention | A staffed program located in the local department of health (DOH) and staffed by DOH personnel currently operates in the comparison county. The program provides supplies (e.g., naloxone, wound care kits, snacks, drinks, resource guides). A peer support specialist from a nearby recovery facility is present for consultation with clients (by request of client) during operating hours. New clients to the program "register" by providing information for establishment of a client ID and answer a brief survey of demographic and behavioral questions used by all state programs. Program clients will also receive a resource guide covering the same categories as those covered in the call-back feature of the KyOSK. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of days carrying naloxone
Self-reported recent (past 30-day) frequency of carrying naloxone (continuous)
Measured: Measured at baseline and then every 6 months up to 5 years
Change in frequency of use of substance use treatment, detoxification, and/or peer-support services
Self-reported recent (past 6-month) frequency of engaging in substance use treatment services (binary)
Measured: Measured at baseline and then every 6 months up to 5 years
Change in number of injection-related abscesses
Self-reported recent (past 6 month) number of injection-site abscesses among those who inject drugs (continuous)
Measured: Measured at baseline and then every 6 months up to 5 years
Secondary outcomes (8)
Change in frequency of condom-less anal and/or vaginal sex
Self-reported recent (past 30-day) frequency of anal or vaginal sex without a condom (continuous; number and proportion of all sex events)
Measured: Measured at baseline and then every 6 months up to 5 years
Change in frequency of overdose
Self-reported number of times overdosed in the past 6 months (continuous).
Measured: Measured at baseline and then every 6 months up to 5 years
Change in use of naloxone during overdose events by participants who witnessed an overdose
Self-reported number of times participant used naloxone to reverse someone's overdose in the past 6 months (continuous)
Measured: Measured at baseline and then every 6 months up to 5 years
Change in number of days on medications for opioid use disorder (MOUD) among participants who use opioids to get high
Self-reported recent (past 30-day) frequency of being on MOUD (continuous)
Measured: Measured at baseline and then every 6 months up to 5 years
Change in frequency of helping others access naloxone
Self-reported recent (past 6 months) frequency of providing naloxone to others (binary)
Measured: Measured at 18-month follow-up and thereafter
Change in frequency of hospitalization for an injection-related infection
Self-reported recent (past 6 month) hospitalization for an injection-site infection among those who inject drugs (binary)
Measured: Measured at baseline and then every 6 months up to 5 years
Change in frequency of helping others access wound care
Self-reported recent (past 6 month) frequency of providing wound care supplies to other (binary)
Measured: Measured at 18-month follow-up and thereafter
Change in recovery capital
Composite measure of recent (past 6 month) self-reported social capital (receipt and provision of support), physical capital (housing, transportation, food security, technology, and health care access), and human capital (quality of life, experience of shame) (continuous)
Measured: Measured at baseline and then every 6 months up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start6 Mar 2023
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-Related DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.
- Masking
- None (open label)
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- April M Young
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, April M Young, University of Kentucky
- Investigators
- April M Young, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657106
- Sponsor's protocol ID
- KyOSK
- Other IDs
- 1R01DA055872
- Status last verified
- Aug 2026
- First submitted
- 3 Nov 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Young AM, Jahangir T, Westneat S, Cheatom C, Fallin-Bennett A, Fanucchi LC, Freeman PR, Havens JR, Knudsen HK, McCollister KE, Stitzer S, Stone J, Vickerman P, Livingston MD. Preferences for harm reduction vending machine design among rural people who use drugs. Drug Alcohol Depend Rep. 2025 Oct 31;17:100391. doi: 10.1016/j.dadr.2025.100391. eCollection 2025 Dec.
PubMed 41322680Young AM, Havens JR, Cooper HLF, Fallin-Bennett A, Fanucchi L, Freeman PR, Knudsen H, Livingston MD, McCollister KE, Stone J, Vickerman P, Freeman E, Jahangir T, Larimore E, White CR, Cheatom C, Community Staff K, Design Team K. Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV, HCV and overdose risk in rural Appalachia. BMJ Open. 2024 Mar 1;14(3):e083983. doi: 10.1136/bmjopen-2024-083983.
PubMed 38431295
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kentucky Outreach Service Kiosk (KyOSK): Addressing Health Needs and Improving Service Linkage in Rural Appalachia Through Health Kiosks
- ClinicalTrials.gov ID
- NCT05657106
- Acronym / sponsor ID
- KyOSK
- Conditions
- Opioid-Related Disorders, Hepatitis C (HCV), Human Immunodeficiency Virus (HIV), Drug Overdose, Substance Abuse, Intravenous Drug Usage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 752 participants (actual)
- Lead sponsor
- April M YoungUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Dec 2022 (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.
This study will test the effectiveness, implementation outcomes, and cost effectiveness of a locally-tailored, health kiosk to reduce overdose, hepatitis C, and HIV risk behavior and improve linkage to care in rural Appalachia. The proposed project will take place in two counties in Appalachian Kentucky, an epicenter for the intertwined national crises of overdoses, hepatitis C, and injection-related infections.
Detailed description
This is a Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial to assess the impact of a community-tailored health kiosk on HIV, HCV, and overdose risk in rural Appalachia, and a mixed methods evaluation of implementation outcomes. The trial will compare the standard health department program (staffed, brick-and-mortar) to an enhanced model involving a health kiosk + standard health department program. The kiosk, referred to as the KyOSK (Kentucky Outreach Service Kiosk) will be tailored through a community-engaged adaptation process. For evaluation of the KyOSK, the investigators will enroll 750 People Who Use Drugs (PWUD) in the intervention (n=425) and comparison (n=325) counties, collectively referred to as the kiosk trial cohort. The kiosk trial cohort will be recruited from three sources: existing cohorts of PWUD, local agencies, and peer-referral. Throughout the trial and following the implementation outcome framework (IOF) measurement model by Proctor et al., acceptability, appropriateness, fidelity, cost, penetration, and sustainability will be assessed using a combination of validated scales, qualitative interviews, checklists, invoices, and program data. Following the trial, the investigators will use data collected from the kiosk cohort and implementation outcome assessment (primarily cost and reach) in a dynamic, deterministic model of HCV transmission and overdose to examine the impact and cost-effectiveness of the KyOSK model.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Type 1 hybrid effectiveness study involving a community-level, controlled quasi-experimental trial and a mixed methods evaluation of implementation outcomes.
| Arm | Type | Receives |
|---|---|---|
| Health Department Program Plus a Health Kiosk Intervention | Experimental | Behavioral: Health kioskThe intervention involves enhancing the health department's existing staffed model of service delivery with a KyOSK. The intervention county's staffed program operates identically to the comparison county. Both counties' staffed programs and the kiosk will use an identically structured unique ID to provide objective data on service engagement. The KyOSK will resemble a vending machine but with a touchscreen, audiovisual interface. The KyOSK will include naloxone, wound care kits, and supplies for basic needs (e.g., hygiene items, food, water, emergency blankets); offer overdose education materials; and an innovative call-back feature for care navigation by recovery coaches. While the KyOSK is operating, the county will continue to operate its traditional program. |
| Staffed Health Department Program | No intervention | –A staffed program located in the local department of health (DOH) and staffed by DOH personnel currently operates in the comparison county. The program provides supplies (e.g., naloxone, wound care kits, snacks, drinks, resource guides). A peer support specialist from a nearby recovery facility is present for consultation with clients (by request of client) during operating hours. New clients to the program "register" by providing information for establishment of a client ID and answer a brief survey of demographic and behavioral questions used by all state programs. Program clients will also receive a resource guide covering the same categories as those covered in the call-back feature of the KyOSK. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 or older,
- live in the intervention or comparison county, and
- have engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco).
Key exclusion criteria (8 listed)
- being under the age of 18,
- not living in the intervention or comparison county,
- having not engaged in injection or non-injection illicit drug use to get high in the past 6 months (excluding marijuana, alcohol, and tobacco),
- not being able to speak or understand English,
- conviction in the past 10 years of a violent crime (i.e., murder, manslaughter, rape, robbery, and /or aggravated assault) or stalking,
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 |
|---|---|---|
| Health kioskThe intervention involves enhancing its existing health department model with a Kentucky Outreach Service Kiosk (KyOSK). | Behavioural | Health Department Program Plus a Health Kiosk Intervention |
Primary outcome
Change in number of days carrying naloxone
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 30-day) frequency of carrying naloxone (continuous)
Change in frequency of use of substance use treatment, detoxification, and/or peer-support services
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 6-month) frequency of engaging in substance use treatment services (binary)
Change in number of injection-related abscesses
Time frame: Measured at baseline and then every 6 months up to 5 years
Self-reported recent (past 6 month) number of injection-site abscesses among those who inject drugs (continuous)
8 secondary outcomes
Change in frequency of condom-less anal and/or vaginal sex
Time frame: Measured at baseline and then every 6 months up to 5 years
Change in frequency of overdose
Time frame: Measured at baseline and then every 6 months up to 5 years
Change in use of naloxone during overdose events by participants who witnessed an overdose
Time frame: Measured at baseline and then every 6 months up to 5 years
Change in number of days on medications for opioid use disorder (MOUD) among participants who use opioids to get high
Time frame: Measured at baseline and then every 6 months up to 5 years
Change in frequency of helping others access naloxone
Time frame: Measured at 18-month follow-up and thereafter
Change in frequency of hospitalization for an injection-related infection
Time frame: Measured at baseline and then every 6 months up to 5 years
Change in frequency of helping others access wound care
Time frame: Measured at 18-month follow-up and thereafter
Change in recovery capital
Time frame: Measured at baseline and then every 6 months up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 41322680Young AM, Jahangir T, Westneat S, Cheatom C, Fallin-Bennett A, Fanucchi LC, Freeman PR, Havens JR, Knudsen HK, McCollister KE, Stitzer S, Stone J, Vickerman P, Livingston MD. Preferences for harm reduction vending machine design among rural people who use drugs. Drug Alcohol Depend Rep. 2025 Oct 31;17:100391. doi: 10.1016/j.dadr.2025.100391. eCollection 2025 Dec.
- Derived from this study: PubMed 38431295Young AM, Havens JR, Cooper HLF, Fallin-Bennett A, Fanucchi L, Freeman PR, Knudsen H, Livingston MD, McCollister KE, Stone J, Vickerman P, Freeman E, Jahangir T, Larimore E, White CR, Cheatom C, Community Staff K, Design Team K. Kentucky Outreach Service Kiosk (KyOSK) Study protocol: a community-level, controlled quasi-experimental, type 1 hybrid effectiveness study to assess implementation, effectiveness and cost-effectiveness of a community-tailored harm reduction kiosk on HIV, HCV and overdose risk in rural Appalachia. BMJ Open. 2024 Mar 1;14(3):e083983. doi: 10.1136/bmjopen-2024-083983.
- Individual participant dataSharing planned: No
Related trials for Opioid-Related Disorders
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
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.
April M Young, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health kiosk in people with Opioid-Related Disorders and Hepatitis C (HCV), run by April M Young at 1 site in United States.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in number of days carrying naloxone (time frame: Measured at baseline and then every 6 months up to 5 years). The study lists 3 primary outcomes in all. 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 NCT05657106, which also lists 2 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 18 Aug 2026.