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HIV InfectionsSCOPENCT05977881

Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement Study

A study testing CHECKIT! in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Completed

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

Official record
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Trial summary

Through the proposed Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement (SCOPE) study, the investigators will design and evaluate an overdose prevention and HIV prevention study among people who use drugs (PWUD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
CHECKIT!
Could I receive a placebo?
No, everyone receives an active treatment
How many people
493 participants
Where
1 siteUnited States
Study dates
28 Jul 2023to 1 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older,
  • self-reports having used illicit stimulants or opioids at least once in the past 3 months,
  • self-reports being HIV negative
  • reports injection drug use in the past 6 months OR reports at least one of the following indicators of sexual HIV risk exposure in the past 6 months:
  • Sexually Transmitted Infection (STI) diagnosis in the past 6 months
  • "Condom-less" vaginal or anal sex in the past 6 months
Show all 9Show fewer
  • Willing to provide a urine sample for urine drug screening of substances
  • Willing to undergo rapid HIV testing
  • Willing to undergo STI testing

Who cannot join

  • Determined to be too high or drunk or cognitively impaired, less than 18 years of age
  • unwilling to provide all required biological specimens (Phase 3 only)
  • unwilling/unable to give consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins School of Public Health

    Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: Impact of a Novel HIV Peer Navigation and Overdose Prevention Intervention on Engagement in the HIV Prevention and Treatment Cascade

Through the proposed Substance Checking Outreach and Pre-Exposure Prophylaxis (PrEP) Engagement (SCOPE) study, the investigators will design and evaluate an overdose prevention and HIV prevention study among people who use drugs (PWUD). Specifically, SCOPE will provide access to drug-checking services for PWUD to better understand the contents of the drug supply, in combination with PrEP for those who are HIV-, to both reduce overdose and HIV among PWUD in Baltimore City.

Read the detailed description

specific study aims are:

  1. To prepare the drug-checking technology for deployment in the community through a three-phase process.
  2. To calibrate drug-checking technology through testing samples of illicit substances on the Bruker Alpha obtained from the Baltimore Police crime lab (N=335) and those obtained through the SPARC outreach sessions (N=100).
  3. To validate the drug-checking technology, measuring sensitivity and specificity in detecting illicit substances of public health relevance, by testing samples obtained through partnerships through Baltimore-based harm reduction organizations and comparing findings to the gold standard (laboratory testing).
  4. To pilot the study Bruker Alpha Fourier Transform Infrared Spectroscopy (FT-IR) drug checking machine among People who use drugs (PWUD) (N=20).
  5. To develop a community-level, mobile, integrated drug checking and PrEP intervention aimed to increase PWUD engagement in the PrEP care continuum and reduce the burden of overdose.
  6. To recruit a longitudinal cohort of people who use drugs (N=500) and follow-up at 6-month intervals for 18 months.
  7. To implement the intervention and evaluate its impact on engagement in PrEP care (primary outcome) and overdose prevention among PWUD.
  8. To determine the incremental cost-effectiveness of the intervention in terms of HIV cases averted among PWUD.
  9. To assess changes in drug-related wounds among N=100 PWUD in Baltimore who receive wound care services on the intervention van.
  10. To assess changes in drug-related wounds specifically attributed to xylazine.

The initial non-human subjects research plan focused on Aim's 1 drug checking machine calibration among samples procured from the Baltimore Police Forensics Lab tested in Dr. William Clarke's lab and from individuals interacting with SPARC staff during the outreach which occurs 3-4 times per week. These activities are referred to as "Phase 1" throughout this research plan. Based on emerging best practices and in consultation with other drug checking initiatives nationwide, the investigators have now expanded Aim 1 of the study to include three steps needed to prepare the machine for deployment in the field: The first (1a) was calibration of the machine to the local drug supply, as described above; the second (1b) which the investigators are adding in this amendment is an additional validation of the machine's functionality and comparison with gold standard technology; and the third (1c) is piloting the machine with 20 PWUD prior to rolling it out citywide.

Conditions
HIV Infections
Being tested
CHECKIT!
Keywords
Drug Use, Overdose, PrEP, Harm Reduction
Medical subject headings
HIV Infections, Drug Overdose, Harm Reduction

What participants receive

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

  • CHECKIT!Other

    Participants will not be assigned to the intervention as it will be available to everyone.

    Check it will be a van-based HIV- and overdose-prevention program offered in the four areas of Baltimore city from which study participants are recruited. Intervention services will include point-of-care drug checking and PrEP assessment, prescription, and management, and they will be available to everyone, regardless of whether they are part of the SCOPE study cohort or not.

    Individual-level service usage data collected by intervention staff will not be considered in analysis of outcomes. However, study participants will self-report Check it utilization on the internally-developed surveys at 6, 12, and 18 months.

Study groups in NCT05977881
Study groupRoleWhat they receive
SCOPE CohortOtherA cohort of PWUD (N=500) living in Baltimore. We will follow-up with participants every 6 months (for 18 months) in five recruitment zones throughout Baltimore (n=125/zone). The four recruitment zones will overlap the intervention sites. There will be four study visits (baseline, 6 months, 12 months, 18 months) total for participants.
Receives: Other: CHECKIT!

What is being measured

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

  1. Current PrEP status as assessed by study team instrument items

    Investigators will measure current PrEP status by assessing participant self-report using an internally developed questionnaire. Change in current PrEP status will be measured using three survey items asking participants 1) if they are currently prescribed either form of PrEP (pill form or injection), 2) currently taking/not taking the prescription, and 3) which type/brand of PrEP are they currently taking. The response range options for current prescription and currently taking PrEP are binary (yes/no) and nominal (choices) for type of PrEP prescribed. Participants will indicate whether they are currently prescribed PrEP, currently taking PrEP and which type prescribed/taking at each study visit.

    Measured: Measured at Baseline, 6, 12, and 18 months

  2. Change in PrEP uptake as assessed by study team instrument items

    Change in PrEP status (uptake) at follow-up is measured using three items with response range options for current prescription and currently taking PrEP are binary (yes/no) and nominal (choices) for type of PrEP prescribed. If participants self-report current PrEP use at follow-up, investigators will confirm the biological presence of PrEP using dried blood spot (DBS) sampling. Samples will be transported to the Clinical Pharmacology Analytical Laboratory (CPAL) where they will be processed using FDA-validated assays analyzing drug and metabolite concentrations. Sample results will be used to compare participant self-report on the study team survey instrument (e.g., what is the concordance/discordance between PrEP presence in DBS samples and yes/no responses to the currently taking PrEP survey item).

    Measured: Measured at 6, 12, 18 months

Secondary outcomes (1)

  1. Change in HIV Risk Behaviors as assessed by study team instrument items

    Investigators will measure change in HIV risk behaviors using self-report with an internally developed questionnaire; there are several items in the instrument to capture 1) episodes of syringe sharing in the prior 30 days and 2) episodes of unprotected vaginal or anal intercourse. Response options for HIV risk behaviors are continuous (counts # of times of episodes) and response options for HIV prevention techniques used are nominal; e.g., 'used a condom with my main sexual partner', or 'take HIV PrEP', or, 'did you use syringes after someone else?'.

    Measured: Measured at Baseline, 6, 12, 18 months

Timeline

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

  1. First posted7 Aug 2023
  2. Study start28 Jul 2023
  3. Primary completion1 May 2026
  4. Study completion1 May 2026

Resources

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
Not applicable
Intervention model
Single group
Model description
The study interventional model is at the community level; the intervention will be offered in all areas in which the cohort will be recruited.
Masking
None (open label)
Enrolment
493 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05977881
Sponsor's protocol ID
IRB00017498
Other IDs
5R01DA053184
Acronym
SCOPE
Status last verified
May 2026
First submitted
27 Jul 2023
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Project de-identified IPD will made available for published analyses upon request. The investigators will also include the study protocol (IPD supporting information).

Publications

  • Murphy SL, Xu J, Kochanek KD, Arias E. Mortality in the United States, 2017. NCHS Data Brief. 2018 Nov;(328):1-8.

    PubMed 30500322

  • Hedegaard H, Minino AM, Warner M. Drug Overdose Deaths in the United States, 1999-2017. NCHS Data Brief. 2018 Nov;(329):1-8.

    PubMed 30500323

  • Centers for Disease Control and Prevention. HIV Infection Risk, Prevention, and Testing Behaviors among Persons Who Inject Drugs-National HIV Behavioral Surveillance: Injection Drug Use, 23 U.S. Cities, 2018. HIV Surveillance Special Report. 2020;24.

  • Des Jarlais DC, Nugent A, Solberg A, Feelemyer J, Mermin J, Holtzman D. Syringe Service Programs for Persons Who Inject Drugs in Urban, Suburban, and Rural Areas - United States, 2013. MMWR Morb Mortal Wkly Rep. 2015 Dec 11;64(48):1337-41. doi: 10.15585/mmwr.mm6448a3.

    PubMed 26655918

  • Beyrer C, Malinowska-Sempruch K, Kamarulzaman A, Kazatchkine M, Sidibe M, Strathdee SA. Time to act: a call for comprehensive responses to HIV in people who use drugs. Lancet. 2010 Aug 14;376(9740):551-63. doi: 10.1016/S0140-6736(10)60928-2.

    PubMed 20650515

  • Aspinall EJ, Nambiar D, Goldberg DJ, Hickman M, Weir A, Van Velzen E, Palmateer N, Doyle JS, Hellard ME, Hutchinson SJ. Are needle and syringe programmes associated with a reduction in HIV transmission among people who inject drugs: a systematic review and meta-analysis. Int J Epidemiol. 2014 Feb;43(1):235-48. doi: 10.1093/ije/dyt243. Epub 2013 Dec 27.

    PubMed 24374889

  • Glick SN, Prohaska SM, LaKosky PA, Juarez AM, Corcorran MA, Des Jarlais DC. The Impact of COVID-19 on Syringe Services Programs in the United States. AIDS Behav. 2020 Sep;24(9):2466-2468. doi: 10.1007/s10461-020-02886-2. No abstract available.

    PubMed 32333209

  • Alpren C, Dawson EL, John B, Cranston K, Panneer N, Fukuda HD, Roosevelt K, Klevens RM, Bryant J, Peters PJ, Lyss SB, Switzer WM, Burrage A, Murray A, Agnew-Brune C, Stiles T, McClung P, Campbell EM, Breen C, Randall LM, Dasgupta S, Onofrey S, Bixler D, Hampton K, Jaeger JL, Hsu KK, Adih W, Callis B, Goldman LR, Danner SP, Jia H, Tumpney M, Board A, Brown C, DeMaria A Jr, Buchacz K. Opioid Use Fueling HIV Transmission in an Urban Setting: An Outbreak of HIV Infection Among People Who Inject Drugs-Massachusetts, 2015-2018. Am J Public Health. 2020 Jan;110(1):37-44. doi: 10.2105/AJPH.2019.305366. Epub 2019 Nov 14.

    PubMed 31725317

  • Atkins A, McClung RP, Kilkenny M, Bernstein K, Willenburg K, Edwards A, Lyss S, Thomasson E, Panneer N, Kirk N, Watson M, Adkins E, DiNenno E, Hogan V, Neblett Fanfair R, Napier K, Ridpath AD, Perdue M, Chen M, Surtees T, Handanagic S, Wood H, Kennebrew D, Cohn C, Sami S, Eubank S, Furukawa NW, Rose B, Thompson A, Spadafora L, Wright C, Balleydier S, Broussard D, Reynolds P, Carnes N, Haynes N, Sapiano T, McBee S, Campbell E, Batdorf S, Scott M, Boltz M, Wills D, Oster AM. Notes from the Field: Outbreak of Human Immunodeficiency Virus Infection Among Persons Who Inject Drugs - Cabell County, West Virginia, 2018-2019. MMWR Morb Mortal Wkly Rep. 2020 Apr 24;69(16):499-500. doi: 10.15585/mmwr.mm6916a2. No abstract available.

    PubMed 32324723

  • Strathdee SA, Beyrer C. HIV Outbreak in Indiana. N Engl J Med. 2015 Oct;373(14):1380-1. doi: 10.1056/NEJMc1510396. No abstract available.

    PubMed 26422741

  • Geddes L, Iversen J, Memedovic S, Maher L. Intravenous fentanyl use among people who inject drugs in Australia. Drug Alcohol Rev. 2018 Apr;37 Suppl 1:S314-S322. doi: 10.1111/dar.12668. Epub 2018 Feb 6.

    PubMed 29405465

  • Lambdin BH, Bluthenthal RN, Zibbell JE, Wenger L, Simpson K, Kral AH. Associations between perceived illicit fentanyl use and infectious disease risks among people who inject drugs. Int J Drug Policy. 2019 Dec;74:299-304. doi: 10.1016/j.drugpo.2019.10.004. Epub 2019 Nov 13.

    PubMed 31733979

  • Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States-2014: a clinical practice guideline. Atlanta: Centers for Disease Control and Prevention. 2014:67.

  • Shrestha R, Copenhaver M. Exploring the Use of Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among High-Risk People Who Use Drugs in Treatment. Front Public Health. 2018 Jul 13;6:195. doi: 10.3389/fpubh.2018.00195. eCollection 2018.

    PubMed 30062091

  • Centers for Disease Control and Prevention. HIV Infection Risk, Prevention, and Testing Behaviors among Persons Who Inject Drugs-National HIV Behavioral Surveillance: Injection Drug Use, 23 U.S. Cities, 2018. 2020;24:43.

Questions about this trial

What is this clinical trial studying?

A study testing CHECKIT! in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health 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 9 inclusion and 3 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 14 May 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?

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?

Current PrEP status as assessed by study team instrument items (time frame: Measured at Baseline, 6, 12, and 18 months). The study lists 2 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 NCT05977881, which also lists 48 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 14 May 2026.

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SCOPE Clinical Trial NCT05977881 | AzTrials