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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00104148 | Other Identifier | Duke University Health System |
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The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The study objectives are the following:
The study population is people who inject drugs, specifically opioids, and who access services at SSPs in Charlotte and Wilmington, NC. The study team will enroll 20 PWID accessing the participating SSPs in Charlotte and Wilmington, NC (10 from each site). Participants will be enrolled in the study for 6 months. At the end of the study, they will be referred to MOUD and PrEP providers identified in the community.
Data collection
Enrollment visit:
The study coordinator will administer the SOCRATES 8D and a baseline survey to collect demographics, HIV risk behaviors, and substance use history. Participants will undergo laboratory testing at the SSP to determine eligibility and enrolled participants will be prescribed bup/nx and PrEP free of charge.
Follow up visits:
Follow-up visits will be conducted via telemedicine at the SSPs. For the first month (Month 1), telemedicine visits will be weekly with each study participant to ensure that they are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly. Participants will be asked to complete a questionnaire at Month 3 and Month 6 which include questions on HIV risk and drug use, as well as adherence evaluation for both bup/nx and PrEP.
By the end of the study, we hope to determine the following:
We will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment.
Under the secondary ID, IRB Pro00104148, we will conduct an ancillary study to contribute to the overall feasibility purpose of the primary study (Pro00104147) by collecting qualitative data from program users. The ancillary study will include conducting in-depth interviews (IDIs) with 10 to 20 participants in the primary study at the end of their month 1 telemedicine visit and at the end of their month 6 telemedicine visit (completion of the primary study). We will use applied thematic analysis to analyze participants' narratives. We chose to position this assessment within an ancillary protocol rather that embed it within the primary study in order to reduce the potential for socially desirable responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication and telemedicine follow up | Experimental | All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suboxone | Drug | Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months | Defined as self-reported opioid use in prior month | 3 months |
| Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months | Defined as self-reported opioid use in prior month. | 6 months |
| Number of Participants Who Remain HIV Negative at 3 Months | Measured via negative HIV test. | 3 months |
| Number of Participants Who Remain HIV Negative at 6 Months | Measured via negative HIV test. | 6 months |
| Persistence in Care at 3 Months | Defined as the number of participants who remain on treatment (MOUD or PrEP). | 3 months |
| Persistence in Care at 6 Months | Defined as the number of participants who remain on treatment (MOUD or PrEP). | 6 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Motivators and Barriers Affecting Medication Adherence and Persistence | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method) | 6 month |
| Motivators and Barriers Affecting Program Persistence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehri McKellar, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen City Needle Exchnge | Charlotte | North Carolina | 28215 | United States | ||
| Duke Department of Population Health Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24238956 | Background | Mars SG, Bourgois P, Karandinos G, Montero F, Ciccarone D. "Every 'never' I ever said came true": transitions from opioid pills to heroin injecting. Int J Drug Policy. 2014 Mar;25(2):257-66. doi: 10.1016/j.drugpo.2013.10.004. Epub 2013 Oct 19. | |
| 21689917 | Background | Lankenau SE, Teti M, Silva K, Jackson Bloom J, Harocopos A, Treese M. Initiation into prescription opioid misuse amongst young injection drug users. Int J Drug Policy. 2012 Jan;23(1):37-44. doi: 10.1016/j.drugpo.2011.05.014. Epub 2011 Jun 20. |
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We will not share IPD with other researchers.
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Recruited people who inject drugs, who access services at syringe services programs in Wilmington and Charlotte, North Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medication and Telemedicine Follow up | All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Medication and Telemedicine Follow up | All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months | Defined as self-reported opioid use in prior month | Data not collected on 8 participants. | Posted | Count of Participants | Participants | 3 months |
|
Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medication and Telemedicine Follow up | All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine Suboxone: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. PrEP: Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mehri McKellar | Duke University | (919) 613-6129 | mehri.mckellar@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2020 | May 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D040242 | Risk Reduction Behavior |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| D065129 | Pre-Exposure Prophylaxis |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| PrEP | Drug | Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. |
|
|
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method) |
| 6 month |
| Participant Perceived Usefulness of the Program | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method) | 6 month |
| Participant Perceived Usefulness of the Program | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method) | 1 month |
| Participant Satisfaction With the Program | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method) | 6 month |
| Participant Satisfaction With the Program | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method) | 1 month |
| Perceptions of Medical Care Quality Via a Telemedicine Video Platform | Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method) | 6 month |
| Ease/Difficulty of Accessing the Telemedicine Video Platform | Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method) | 1 month |
| Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine | Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant over time (qualitative method) | 6 month |
| Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine | Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method) | 1 month |
| Durham |
| North Carolina |
| 27701 |
| United States |
| North Carolina Harm Reduction Coalition | Wilmington | North Carolina | 28403 | United States |
| 21883604 | Background | Young AM, Havens JR. Transition from first illicit drug use to first injection drug use among rural Appalachian drug users: a cross-sectional comparison and retrospective survival analysis. Addiction. 2012 Mar;107(3):587-96. doi: 10.1111/j.1360-0443.2011.03635.x. Epub 2011 Oct 26. |
| 24300900 | Background | Al-Tayyib AA, Rice E, Rhoades H, Riggs P. Association between prescription drug misuse and injection among runaway and homeless youth. Drug Alcohol Depend. 2014 Jan 1;134:406-409. doi: 10.1016/j.drugalcdep.2013.10.027. Epub 2013 Nov 7. |
| 18192204 | Background | Valdez A, Neaigus A, Cepeda A. Potential risk factors for injecting among Mexican American non-injecting heroin users. J Ethn Subst Abuse. 2007;6(2):49-73. doi: 10.1300/J233v06n02_05. |
| 23769234 | Background | Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, Chiamwongpaet S, Kitisin P, Natrujirote P, Kittimunkong S, Chuachoowong R, Gvetadze RJ, McNicholl JM, Paxton LA, Curlin ME, Hendrix CW, Vanichseni S; Bangkok Tenofovir Study Group. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013 Jun 15;381(9883):2083-90. doi: 10.1016/S0140-6736(13)61127-7. Epub 2013 Jun 13. |
| 29559865 | Background | Velander JR. Suboxone: Rationale, Science, Misconceptions. Ochsner J. 2018 Spring;18(1):23-29. No abstract available. |
| 17933486 | Background | Sullivan LE, Moore BA, Chawarski MC, Pantalon MV, Barry D, O'Connor PG, Schottenfeld RS, Fiellin DA. Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat. 2008 Jul;35(1):87-92. doi: 10.1016/j.jsat.2007.08.004. Epub 2007 Oct 15. |
| 30311777 | Background | Bazzi AR, Biancarelli DL, Childs E, Drainoni ML, Edeza A, Salhaney P, Mimiaga MJ, Biello KB. Limited Knowledge and Mixed Interest in Pre-Exposure Prophylaxis for HIV Prevention Among People Who Inject Drugs. AIDS Patient Care STDS. 2018 Dec;32(12):529-537. doi: 10.1089/apc.2018.0126. Epub 2018 Oct 11. |
| 27896552 | Background | Edelman EJ, Moore BA, Calabrese SK, Berkenblit G, Cunningham C, Patel V, Phillips K, Tetrault JM, Shah M, Fiellin DA, Blackstock O. Primary Care Physicians' Willingness to Prescribe HIV Pre-exposure Prophylaxis for People who Inject Drugs. AIDS Behav. 2017 Apr;21(4):1025-1033. doi: 10.1007/s10461-016-1612-6. |
| 30732542 | Background | Molfenter T, Fitzgerald M, Jacobson N, McCarty D, Quanbeck A, Zehner M. Barriers to Buprenorphine Expansion in Ohio: A Time-Elapsed Qualitative Study. J Psychoactive Drugs. 2019 Jul-Aug;51(3):272-279. doi: 10.1080/02791072.2019.1566583. Epub 2019 Feb 7. |
| 31251376 | Background | Haffajee RL, Lin LA, Bohnert ASB, Goldstick JE. Characteristics of US Counties With High Opioid Overdose Mortality and Low Capacity to Deliver Medications for Opioid Use Disorder. JAMA Netw Open. 2019 Jun 5;2(6):e196373. doi: 10.1001/jamanetworkopen.2019.6373. |
| 28107210 | Background | Zheng W, Nickasch M, Lander L, Wen S, Xiao M, Marshalek P, Dix E, Sullivan C. Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis. J Addict Med. 2017 Mar/Apr;11(2):138-144. doi: 10.1097/ADM.0000000000000287. |
| 30265425 | Background | Weintraub E, Greenblatt AD, Chang J, Himelhoch S, Welsh C. Expanding access to buprenorphine treatment in rural areas with the use of telemedicine. Am J Addict. 2018 Dec;27(8):612-617. doi: 10.1111/ajad.12805. Epub 2018 Sep 28. |
| 11718472 | Background | Centers for Disease Control and Prevention. Revised guidelines for HIV counseling, testing, and referral. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):1-57; quiz CE1-19a1-CE6-19a1. |
| 38532395 | Derived | McKellar MS, Des Marais AC, Chen H, Choi Y, Lilly R, Ayers D, Bennett J, Kestner L, Perry B, Poley S, Corneli A, Meade CS, Sachdeva N. Providing medication for opioid use disorder and HIV pre-exposure prophylaxis at syringe services programs via telemedicine: a pilot study. Harm Reduct J. 2024 Mar 26;21(1):69. doi: 10.1186/s12954-024-00983-2. |
| 36463214 | Derived | Corneli A, Perry B, Des Marais A, Choi Y, Chen H, Lilly R, Ayers D, Bennett J, Kestner L, Meade CS, Sachdeva N, McKellar MS. Participant perceptions on the acceptability and feasibility of a telemedicine-based HIV PrEP and buprenorphine/naloxone program embedded within syringe services programs: a qualitative descriptive evaluation. Harm Reduct J. 2022 Dec 3;19(1):132. doi: 10.1186/s12954-022-00718-1. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Education completed measured via self-report | Count of Participants | Participants |
|
| Insurance status | Insurance coverage measured via self-report | Count of Participants | Participants |
|
| Relationship status | Relationship status measured via self-report | Count of Participants | Participants |
|
| Employment | Employment status measured via self-report | Count of Participants | Participants |
|
| Ever taken Suboxone | Whether the participant has ever taken Suboxone prior to the study measured via self-report | Count of Participants | Participants |
|
| Ever Overdosed | Whether the participant has ever overdosed on heroin, fentanyl, or prescription pain medication measured via self-report | Count of Participants | Participants |
|
| Access to technology | Technology participants have access to measured via self-report | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months | Defined as self-reported opioid use in prior month. | Data not collected on 11 participants. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Number of Participants Who Remain HIV Negative at 3 Months | Measured via negative HIV test. | Received labs to confirm HIV status from 8 participants at month 3. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | Number of Participants Who Remain HIV Negative at 6 Months | Measured via negative HIV test. | Received labs to confirm HIV status from 3 participants at month 6 | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Persistence in Care at 3 Months | Defined as the number of participants who remain on treatment (MOUD or PrEP). | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Primary | Persistence in Care at 6 Months | Defined as the number of participants who remain on treatment (MOUD or PrEP). | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Motivators and Barriers Affecting Medication Adherence and Persistence | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method) | Not Posted | 6 month | Participants |
| Other Pre-specified | Motivators and Barriers Affecting Program Persistence | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method) | Not Posted | 6 month | Participants |
| Other Pre-specified | Participant Perceived Usefulness of the Program | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method) | Not Posted | 6 month | Participants |
| Other Pre-specified | Participant Perceived Usefulness of the Program | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method) | Not Posted | 1 month | Participants |
| Other Pre-specified | Participant Satisfaction With the Program | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method) | Not Posted | 6 month | Participants |
| Other Pre-specified | Participant Satisfaction With the Program | Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method) | Not Posted | 1 month | Participants |
| Other Pre-specified | Perceptions of Medical Care Quality Via a Telemedicine Video Platform | Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method) | Not Posted | 6 month | Participants |
| Other Pre-specified | Ease/Difficulty of Accessing the Telemedicine Video Platform | Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method) | Not Posted | 1 month | Participants |
| Other Pre-specified | Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine | Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant over time (qualitative method) | Not Posted | 6 month | Participants |
| Other Pre-specified | Ease/Difficulty of Visiting a SSP to Meet With a Provider Via Telemedicine | Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method) | Not Posted | 1 month | Participants |
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D001519 | Behavior |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011322 | Primary Prevention |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D015980 | Public Health Practice |
| D011634 | Public Health |
| D004778 | Environment and Public Health |