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

Abstract

Introduction

Many rural communities bear a disproportionate share of drug-related harms. Innovative harm reduction service models, such as vending machines or kiosks, can expand access to services that reduce drug-related harms. However, few kiosks operate in the USA, and their implementation, impact and cost-effectiveness have not been adequately evaluated in rural settings. This paper describes the Kentucky Outreach Service Kiosk (KyOSK) Study protocol to test the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, hepatitis C and overdose risk in rural Appalachia.

Methods and analysis

KyOSK is a community-level, controlled quasi-experimental, non-randomised trial. KyOSK involves two cohorts of people who use drugs, one in an intervention county (n=425) and one in a control county (n=325). People who are 18 years or older, are community-dwelling residents in the target counties and have used drugs to get high in the past 6 months are eligible. The trial compares the effectiveness of a fixed-site, staffed syringe service programme (standard of care) with the standard of care supplemented with a kiosk. The kiosk will contain various harm reduction supplies accessible to participants upon valid code entry, allowing dispensing data to be linked to participant survey data. The kiosk will include a call-back feature that allows participants to select needed services and receive linkage-to-care services from a peer recovery coach. The cohorts complete follow-up surveys every 6 months for 36 months (three preceding kiosk implementation and four post-implementation). The study will test the effectiveness of the kiosk on reducing risk behaviours associated with overdose, HIV and hepatitis C, as well as implementation outcomes and cost-effectiveness.

Ethics and dissemination

The University of Kentucky Institutional Review Board approved the protocol. Results will be disseminated in academic conferences and peer-reviewed journals, online and print media, and community meetings.

Trial registration number

NCT05657106.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• The intervention was designed through extensive engagement with community partners, including people with substance use experience.

• The hybrid effectiveness trial design will yield insights on effectiveness, economic impact and implementation outcomes, increasing its applicability to guiding future intervention.

• A limitation of the protocol is the inability to blind participants and staff to arm assignment due to the county-level nature of the intervention.

Introduction

Policies and risk environments surrounding drug use place people who use drugs (PWUD) at increased vulnerability to numerous harms,^1–4 including the transmission of bloodborne viruses,^5–9 overdose^9–11 and injection-related bacterial infections.^12–20 Harm reduction programmes reduce PWUD’s risk of these adverse health outcomes,^21–30 but access to these services in the USA and globally remains insufficient.³¹ In the USA, inadequate harm reduction infrastructure is especially problematic in the medically underserved epicentres of the nation’s intertwined overdose and hepatitis C virus (HCV) crises.

Central Appalachia, a predominantly rural, mountainous area encompassing Eastern Kentucky and parts of West Virginia, Virginia and Tennessee, has long experienced a disproportionate burden of HCV,^{32 33} overdose³⁴ and elevated risk of an HIV/HCV outbreak among people who inject drugs (PWID).³⁵ Due to elevated rates of new HIV diagnoses among rural residents, Kentucky was one of few states designated as a priority region for Ending the HIV Epidemic, an initiative by US federal agencies to reduce new infections in the USA by 90% by 2030.³⁶

In an effort to reduce its vulnerability to an HIV outbreak, Kentucky has expanded its harm reduction infrastructure,³⁷ launching 84 syringe service programmes (SSPs)³⁷ in less than 8 years. SSP implementation in Kentucky has been associated with decreases in injection-related infections,³⁸ but there remain substantial gaps in SSPs’ reach.^39–41 In studies of rural Appalachian PWID, only half have used an SSP citing anticipated stigma, lack of privacy, fear of law enforcement, and limited transportation and hours of operation as barriers.^40–45 Nearly all of Appalachian Kentucky’s SSPs are traditional, fixed-site, staffed programmes operated within health departments. Supplementing these traditional programmes with alternative harm reduction service models might reduce barriers and expand access.

Harm reduction vending machines, or kiosks, have been dispensing safe injection supplies in Europe, Australia and elsewhere for up to 30 years,^{46 47} but few have been implemented in the USA. The first kiosks that dispense injection supplies were installed in the USA in 2009⁴⁸ and are largely still limited to Puerto Rico and Nevada. In the USA and elsewhere, kiosk characteristics vary, but typically include supplies for safer injection and overdose prevention, are installed near existing SSPs, and accessed through code, card, token or payment. Previous studies have demonstrated acceptability and uptake among PWID,^49–52 but findings on effectiveness have been mixed, with some studies, finding an association with reduced syringe sharing^{49 53 54} and reuse,⁴⁹ and others not.47 52 55–58

Mixed findings from prior research, study design limitations (ie, ecological, absence of a control group, limited data on individuals not accessing services) and gaps in the studies’ geographical coverage underscore the need for more research on harm reduction kiosks. The Kentucky Outreach Service Kiosk (KyOSK) Study tests the effectiveness, implementation outcomes and cost-effectiveness of a community-tailored, harm reduction kiosk in reducing HIV, HCV and overdose risk behaviour in rural Appalachia. KyOSK is significant in that it will be, to our knowledge, the first controlled trial testing the effectiveness of a harm reduction kiosk in the USA, and the first globally to examine cost-effectiveness. We hypothesise that participants who reside in the intervention county, in which the kiosk is installed, will have reduced overdose, HIV and HCV risk behaviours compared with participants who reside in a comparison county without a kiosk.

Methods

Study setting

KyOSK involves two rural Appalachian Kentucky counties that are similar in their demographic and epidemiological profile (table 1). These counties have been designated as ‘distressed’ or ‘at-risk’ based on several economic indicators.⁵⁹ Standard, fixed-site SSPs have been operating in the counties since 2017.

Table 1.

Description of counties

	Intervention county	Comparison county
Population per square mile86	84	88
Total population age 18 or older86	22 252	19 815
Per cent living in poverty86	30	21
Rural–urban continuum code (range: 1–9)87	7	7
Percentage of population that is rural86	72	65
White, non-Hispanic (%)86	94	92
Per cent of population who speaks English at home88	97	96
Number of HIV cases (total)89	34	29
Number of opioid overdose deaths (2020–2022)90	53	48
Number of opioid overdose emergency department admissions (2021)91	27	35
Number of buprenorphine providers92	15	10
Average number of SSP clients per month93	90	94

SSP, syringe service programme.

Eligibility criteria

People who are 18 years or older, are community-dwelling residents in the target counties and used drugs (excluding marijuana, tobacco or alcohol) to get high in the past 6 months are eligible. Exclusion criteria include being under the age of 18 years, not living in the intervention or comparison county, having not engaged in drug use as defined above, not being able to speak or understand English, conviction in the past 10 years of a violent crime (ie, murder, manslaughter, rape, robbery and/or aggravated assault) or stalking, current charges of violent crime or stalking, having plans to move out of the study counties in the next 6 months or residing in an inpatient facility.

Investigators may remove a participant from the study if worsening health precludes participation; they pose a safety risk to staff; participation is determined to be due to external pressure; or the study is terminated by the Institutional Review Board (IRB), Data Safety Monitoring Board (DSMB) or funder. Participants are not prohibited from concurrent research or care.

Randomisation

KyOSK is a community-level, controlled quasi-experimental trial involving two cohorts of PWUD, one in an intervention and one in a control county. County intervention arm assignment was not random. A waitlist control design was originally envisioned, but one county’s political leaders expressed hesitancy about kiosk installation, desiring instead to serve as the control county and await trial results for guidance on future kiosk installation.

Trial arms

Our trial will compare changes in a cohort accessing a standard, fixed-site SSP staffed by health department personnel in a control county to changes in a cohort accessing this standard model enhanced with a kiosk in an intervention county. We will enrol 750 PWUD, including 425 in the intervention county and 325 in the control county. The intervention county sample is larger because it will require more within-county stratified analyses for SSP and kiosk usage alone and in combination. Participants will complete eight waves of biannual surveys until the participants reach 48 months of follow-up, with the kiosk being implemented at approximately 18-month follow-up. The study timeline is described in table 2. Data collection for the trial began on 6 March 2023 and is anticipated to end in July 2026.

Table 2.

Participant timeline

Time point	Study period
	Enrolment	Allocation	Post-allocation					Close-out
	−18 to 0 months	0 months	6 months	12 months	18 months	24 months	25–30 months	30–36 months
Enrolment
Eligibility screen	X
Informed consent (baseline)	X
Informed consent (preceding kiosk implementation)		X
Interventions
Staffed SSP (control)		X	X	X	X	X	X
Staffed SSP+kiosk (intervention)		X	X	X	X	X	X
Assessments
Baseline survey	X
Follow-up survey		X	X	X	X	X	X
Analysis							X	X

SSP, syringe service programme.

Comparison condition

The SSP staffed by the local health department will serve as the standard-of-care comparison. The SSP provides syringes, cookers, cottons, naloxone, fentanyl test strips, wound care kits, condoms/lubricant, snacks, drinks and sharps containers. At their first visit, clients receive a unique ID and complete a brief survey, with these data stored in a statewide, REDCap database. SSP clients will have similar access to harm reduction supplies as those accessing the kiosk and will receive a trifold resource guide with information on services and contact information for recovery coaches (described below). The staffed SSP currently operates 3 hours per week but scale-up to 40 hours per week will be pursued to align with the timing of the kiosk’s implementation.

Intervention condition

The intervention involves enhancing an existing SSP with a kiosk. Approximately 18 months after initiation of cohort recruitment, a kiosk will be installed and will remain in place for approximately 3 years. While the kiosk is operating, the intervention county will continue its staffed SSP.

Cohort participants in the intervention county will receive a swipe card and alphanumerical code to access the machine. To ensure integration with the state’s REDCap data system, the card and code will use the standard SSP client ID code format. Staff will deactivate cards when a replacement is issued, a participant withdraws, or if the card is lost or stolen.

The kiosk will be located adjacent to the local health department which operates the staffed SSP. The local health department was the most preferred location for a kiosk based on previous research.⁴⁰ The kiosk will resemble a traditional vending machine with a small interface for making selections and receiving information. The kiosk will be stocked with harm reduction supplies (see table 3 for potential supplies). To ensure compliance with the counties’ existing 1:1 exchange requirement, the kiosk will have a sharps receptacle equipped with technology to approximate the number of returned syringes and determine the number allowed to be dispensed.

Table 3.

Potential kiosk supplies and service menu for facilitated referral

Supplies	Services to be listed on menu to which there can be facilitated referral
Naloxone	Housing
Fentanyl test strips	Food assistance
Needles/syringes	Transportation
Sharps containers	HIV/HCV testing and treatment
Condoms	Mental healthcare
Food	Support groups
Water	Domestic violence
Hygiene kits	Substance use disorder treatment
Wound care kits	Help obtaining an identification card
Naloxone voucher for redemption at pharmacy	HIV pre-exposure prophylaxis
Alcohol pads	Health insurance registration
Xylazine test strips	Wound care
Hats and gloves	Legal aid
Period/menstrual products	STI treatment and testing
Housing vouchers	Pregnancy testing
Transportation vouchers	Maternal care
At-home HIV tests	Education assistance
Resource guides

HCV, hepatitis C virus; STI, sexually transmitted infection.

A common concern about kiosks is the potential missed opportunities for linkage to care.^{53 60} To address this concern, the kiosk will feature a care navigation call-back menu. Care navigation can increase PWUD use of community-based services, including increased engagement in substance use disorder treatment.^61–63 Participants will select services displayed on the kiosk’s interface (see table 3 for potential menu) and provide access to their phone number(s) for call-back.

People with lived experience with substance use who are certified and trained recovery coaches (RCs) will monitor the kiosk data dashboard and field call-back requests within 3 business days. RCs will briefly assess service needs and potential barriers and make facilitated referrals to health and support services. RCs will also share that they are a person in recovery and relate where possible to the participant’s situation and provide hope and encouragement. With permission, RCs will follow up in 7 days to offer further assistance. Clients can continue to contact RCs with follow-up questions.

Outcomes

Study outcomes are described in table 4 and in detail on the study overview in ClinicalTrials.gov.⁶⁴ All measures are continuous. Self-reported measures will be assessed using timeline follow-back methods.⁶⁵ Survey logic is used to identify reporting discrepancies in real time and prompt the interviewer to resolve the discrepancy with the participant (ie, reporting more injections involving a clean needle in the past 30 days than total number of injections).

Table 4.

Outcomes

Outcomes	Recall period
Primary outcomes
Change in syringe coverage for injections (number of injections where a clean syringe was used divided by total number of injections among participants who inject drugs)	30 days
Change in harm reduction programme-supplied syringe coverage for injections (number of injections where a clean syringe from the (kiosk/SSP) was used divided by the total number of injections among participants who inject drugs)	30 days
Change in SSP/KyOSK-provided syringe coverage for injections (number of syringes obtained at the SSP and/or kiosk)	30 days
Secondary outcomes
Change in frequency of receptive syringe sharing among participants who inject drugs	30 days
Change in frequency of distributive syringe sharing among participants who inject drugs	30 days
Change in number of people with whom persons shared syringes and injection equipment	30 days
Change in frequency of syringe reuse among participants who inject drugs	30 days
Change in frequency of safe syringe disposal among participants who inject drugs	30 days
Change in frequency of condomless anal and/or vaginal sex	30 days
Change in frequency of overdose	6 months
Change in use of naloxone during overdose events by participants who witnessed an overdose	6 months
Change in number of days carrying naloxone	30 days
Change in number of times contacting or visiting a pharmacy to obtain naloxone	6 months
Change in number of days on medications for opioid use disorder among participants who use opioids to get high	30 days
Change in frequency of use of harm reduction services among participants who inject drugs	30 days
Change in frequency of use of fentanyl test strips among participants who use drugs	30 days
Change in frequency of engagement in overdose protective behaviours among participants who use drugs	30 days

KyOSK, Kentucky Outreach Service Kiosk; SSP, syringe service programme.

Following the Implementation Outcomes Framework,⁶⁶ we will assess acceptability, appropriateness, fidelity, cost, penetration/reach and sustainability. Acceptability and appropriateness will be assessed in the cohort surveys using the Acceptability of Implementation Measure and Intervention Appropriateness Measure, respectively.⁶⁷ Fidelity is described in the Blinding, contamination and fidelity section. Using established methods,^68–72 costs will be estimated from the provider’s perspective and employ a micro-costing approach that measures and values in monetary terms all resources invested and links costs to the primary and secondary outcomes to evaluate economic impact. Penetration (ie, reach) will be determined by examining the number who engage with the kiosk and/or staffed SSP divided by the number enrolled at the time of intervention/comparison condition implementation (ie, per cent who use the kiosk or SSP) and per supply (ie, per cent who accessed each supply) at monthly intervals. Finally, prospects for sustainment will be explored in final year using qualitative, semistructured interviews with SSP and other health department staff and local and state leadership.

Building on existing models,^73–76 we will develop and calibrate⁷⁷ a dynamic, deterministic model of HCV transmission and overdose among PWUD in the intervention county to estimate the kiosk’s impact and cost-effectiveness. The kiosk’s effects will be parameterised using trial data. Impact will be measured as reductions in HCV incidence/prevalence, HCV infections and overdoses averted and quality-adjusted life-years (QALYs) saved over the study and longer time frames (10/20/50 years). Using cost data, we will estimate cost-effectiveness by comparing discounted (3% annually⁷⁸) costs and QALYs over 50 years between model scenarios with and without kiosk introduction. The mean incremental cost-effectiveness ratio will be estimated and compared with US relevant willingness-to-pay per QALY thresholds.⁷⁹

Data collection

Participants are recruited from (1) existing cohort studies of PWUD, (2) the two SSP programmes and (3) peer referral. Recruitment from these sources occurs simultaneously; staff extend invitations and advertise in the SSP, and those who enrol are invited to refer peers (paid for up to five each, $10 per peer). KyOSK recruitment commenced in March 2023. The target sample size is 750, including 425 from the intervention county and 325 from the control county.

Community-based field staff administer surveys programmed in Questionnaire Development System’s (QDS) computer-assisted self-interviewing program, with staff asking participants questions aloud and entering participants’ responses. Participants can skip any question. The survey collects demographic characteristics, sexual and drug-related risk behaviour, houselessness, criminal legal system involvement, substance use disorder treatment, medical care access, harm reduction service access, and social, drug, and sexual network characteristics. Staff administer follow-up surveys every 6 months. Participants receive $35 at baseline and $25 for each follow-up survey.

At baseline, staff administer a 14-panel saliva drug test and fingerstick HIV and HCV antibody tests. Trained staff use the rapid-rapid protocol for HIV testing, involving INSTI HIV 1/HIV 2 Rapid Antibody Test (BioLytical Laboratories, Richmond, British Columbia, Canada) followed by Sure Check HIV-1/2 Antibody Test (Chembio Diagnostic Systems, Medford, New York, USA). Staff use OraQuick HCV Rapid Antibody Test (OraSure, Bethlehem, Pennsylvania, USA) for HCV testing. Staff provide post-test counselling and facilitated referrals for those testing positive.

The kiosk’s software will capture detailed, de-identified data linked only to user ID code. Data will be stored in a secure password-protected database. Data include client-level and visit-level usage including day/time, frequency of use, supply selection and quantity, number of syringes returned and call-back requests. The same data will be collected on clients visiting the SSP.^62–64

Retention

Following standard procedures used in longitudinal research,⁸⁰ participants provide detailed locator information to assist with retention and/or contact for future research including names, pseudonyms, phone numbers, addresses, email addresses, social media contact information and contact information for up to three people who should know how to reach the participant if contact information changes. Participants are contacted at the midpoint of each follow-up interval to update locator information and remind them about their follow-up appointment. Participants receive $10 for updating or verifying locator information between the baseline and 6-month follow-up appointment (the period at which most attrition occurs). In addition, local jail systems are searched to identify if a person is incarcerated. Participants who are incarcerated and have consented to be contacted while incarcerated may complete follow-up surveys from jail (with permission from jail administrative staff).

Blinding, fidelity and contamination

Analysts remain blinded through recruitment and follow-up until completion of primary and secondary analyses, using uninformative participant labels. Due to the nature of the interventions, participants and site staff administering the intervention are not blinded. These staff are instructed to use uninformative labels when discussing participants with blinded investigators.

Fidelity of kiosk and staffed SSP implementation will be assessed early and mid-trial on three domains: (1) supply availability, (2) operation and (3) recovery coaching. Supply availability will be assessed using the kiosk’s internal data in which item selections unfilled due to insufficient stock are recorded. Operation will be assessed by examining the number of kiosk malfunctions and number of times in which the staffed SSP operated <40 hours per week excluding holidays. The latter will be assessed through five unannounced visits per month by research staff at opening, lunch and near closing. Recovery coaching fidelity to best practices will be assessed by monthly review of 10% of randomly selected, audio-recorded sessions and completion of a fidelity checklist, which includes tailoring the conversation to stage of change, using motivational interviewing, engaging in resource brokering and so on.

Potential for contamination is low, as the travel distance between sites is 2 hours. Participants enrolled in the control county will not be provided with a swipe card to access the kiosk in the intervention county. Nevertheless, to assess potential contamination, data will be collected at each follow-up survey about county of residence, SSP and kiosk use, and in which county they accessed services.

Data management

Data are imported to a single warehouse file on our secure network drive. Using the QDS Warehouse Manager program, the data manager assesses transferred data for completeness and consistency and tracks data modifications. Stored data are exported as SAS v9.4 and SPSS v29 datasets for analysis. The list linking participants to their unique identifier is maintained on a secure REDCap database. To protect confidentiality, only de-identified data are shared for analysis.

Statistical methods

The intention-to-treat (ITT) population will contain all enrolled participants according to their assigned study arm. The per-protocol population will include participants who complete the trial as originally allocated. We hypothesise that values on our primary outcome measures of syringe coverage (see outcomes for operationalisation) in the intervention county will be greater than the control county in the ITT and per-protocol populations. We anticipate that the secondary outcomes of risk behaviours (see outcomes for operationalisation) in the intervention county will be less than that reported by those in the control county. We hypothesise that participants in the intervention county will be more likely to engage in the secondary outcomes related to naloxone carriage and medications for opioid use disorder and HCV treatment than those in the comparison county.

All models will be analysed using generalised estimating equations (GEEs) assuming an AR(1) residual structure to account for within-person autocorrelation due to repeated measures, and will include fixed effects for county intervention condition, intervention period and condition×period interaction. This interaction estimates the relative change in the intervention county compared with the control county due to the kiosk’s introduction. Although the counties are remarkably similar, our planned analyses do not rely on baseline equivalence to identify intervention effects. Instead, intervention effects are identified under the assumption that the trends in outcomes over time in the control condition are parallel with those that would be observed in the intervention county in the kiosk’s absence. To further relax this assumption, we will model county-specific linear time effects to allow for different secular trends that may confound estimation of the intervention effect. Multiple baseline measures allow better capture of any potential differential trends. Models will include an indicator variable reflecting whether participants also received services at the staffed SSP and institutionalisation (hospitalised or incarcerated) at the time of the survey. Other theoretically justified time-varying covariates and recruitment method (ie, enrolled from cohort, SSP or peer referral) will be examined. We will examine homophily in peer referral chains and incorporate autocorrelation within chains if significant homophily on outcomes is present. Of note, GEE models are robust to minor misspecifications of the correlation structure that may arise due to the sampling scheme.

Our prior research has shown that the rates of our primary outcomes are high enough to be well approximated as normal. If this does not hold true, we will use Poisson models with appropriate offsets to account for the distribution of the primary ratio outcomes. Type 1 error (α) will be set to 0.05 in primary and secondary outcome analyses, and two-tailed tests will be used. For outcomes that apply only to a subset of participants (eg, syringe sharing analyses are restricted to PWID), data from time points at which participants do not report the relevant behaviour (eg, injection drug use) will be omitted from these models. Resulting estimates will be unbiased under the assumption that the kiosk did not cause a change in the overall behaviour defining the subset (eg, in injection drug use). Sensitivity analyses including all data will be performed using multinomial logistic regression where the outcomes are specified as, for example, no injection drug use, injection drug use with a clean syringe and injection drug use without a clean syringe.

We will use multiple imputation by chained equations⁸¹ to account for attrition in all analyses. Our imputation model will include interactions between intervention county and baseline risk measures to allow for differential selection effects between the intervention and comparison groups should differential attrition arise.⁸²

To analyse reach, we will perform segmented regression analyses using existing data from the statewide SSP database beginning in January 2020 allowing for 3 years of pre-intervention data. We will assess change in total reach by comparing the difference in the changes in both intercept and slope between counties. All models will account for first-order autocorrelation and use appropriate link functions based on outcome distributions. We will also explore changes in reach by gender, age, injection drug use or other characteristics, by generating separate series by participant characteristic and then analysing these series in a pooled interaction model.

Power calculation

Based on prior published simulations,⁸³ our segmented regression analyses (n=72 months, 3 years pre-intervention and 3 years post-intervention implementation) are well powered to achieve study aims for small effects across a wide variety of link functions and autocorrelation values. We estimated power for our primary intervention models using 5000 Monte Carlo simulations for each set of parameters, with a type 1 error rate of 0.05 and an unbalanced design (sample unevenly distributed across counties). We simulated autocorrelated outcomes for three pre-intervention and five post-intervention survey waves with an expected 750 enrollees. We conservatively used 70% retention for the power analysis. Not all outcomes will be applicable to the full cohort; for example, approximately 25% are estimated⁸⁴ to have not recently injected and therefore will not contribute to analyses of outcome variables related to injection. Therefore, we estimated power for various effect sizes for a cohort of ‘completers’ of N=300, 400 and 500. Based on these simulations, all sample sizes are powered to detect a standardised mean difference of at least 0.2, a small effect. As enrolment nears the target sample size, the accuracy of projected estimates of retention and injection drug use will be evaluated and the sample size may be increased if needed.

Data monitoring

A DSMB with a physician, statistician, infectious disease epidemiologist and behavioural scientist with expertise in research among PWUD oversees the study. The DSMB is independent of the sponsor and competing interests. The DSMB meets at least annually to review emerging data and make recommendations about the trial’s conduct, including stopping the trial. No formal interim analyses are planned.

Social harms

Social harms related to participation will be actively assessed and documented. Social harms include any intended or unintended cause of physical, emotional or psychosocial injury or hurt from one participant to another, a participant to themselves or an institution to a participant, occurring as a result of study participation.⁸⁵ Participants will complete a social harms questionnaire at each study visit. Study staff are trained to provide appropriate care, counselling and referral as needed. Any identified social harms are reported to study investigators who determine severity and provide details to the IRB as required.

Auditing

The data scientist regularly assesses data for missingness and data quality and provides feedback to the principal investigator (PI) and field staff regarding any issues that need to be addressed. The PI and project director review study consent materials to assure appropriate documentation of consent at least semiannually.

Patient and public involvement

Participants were not directly involved in the development of the research question, outcome measures or conduct of the trial; however, officials from state and local agencies, and community advisory boards were involved in intervention design. Upon funding, six focus groups with potential clients and local health department personnel were conducted to gain feedback on kiosk features. Then, a KyOSK Design Team including people with lived experience with substance use, local health department partners, state government officials and service leaders was convened to guide kiosk design. A separate community advisory board of people with lived experience with substance use provided feedback on recruitment methods and participated in survey question review and piloting. Upon completion of the study, results will be distributed via study social media pages, websites, local community advisory board, the KyOSK Design Team and to community partners.

Ethics and dissemination

The KyOSK Study is reviewed and approved by the University of Kentucky IRB (protocol #78081). Study staff complete human subjects training and are approved as personnel by the IRB. Protocol modifications, revisions to consent forms and changes to other participant-facing documents are submitted to the University of Kentucky IRB for approval prior to implementation. Protocol modifications are submitted to the IRB prior to implementation and reflected in ClinicalTrials.gov. Approval from the funding agency will be sought for major protocol modifications, such as changes in inclusion criteria or aims, prior to submitting those changes to the IRB.

All participants complete an informed consent process at baseline and at the follow-up appointment preceding kiosk implementation, with the latter going into more detail about the kiosk design and supplies. The consent form describes the protocol, risks and benefits. Consent procedures are completed in person in a private area with only the participant and study staff present.

Findings will be disseminated to the public and healthcare professionals in peer-reviewed journals, professional conferences and community forums. Authorship eligibility guidelines follow International Committee of Medical Journal Editors criteria. We will submit manuscripts to National Institutes of Health Manuscript Submission to be made publicly available no later than 12 months after the official date of publication in compliance with the funder’s open access policy. De-identified data will be made available to interested parties upon submission and approval of a written request describing data security protocols and intended use.

Ethics statements

Patient consent for publication

Not applicable.