Drug-Checking Services + PrEP for HIV Prevention

(SCOPE Trial)

Overseen By Susan G Sherman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Must be taking: PrEP

Disqualifiers: Cognitive impairment, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent overdoses and HIV among people who use drugs in Baltimore City. Participants will access drug-checking services to identify substances they are taking and PrEP (a daily pill to prevent HIV) if they are HIV-negative. The trial focuses on individuals who have used stimulants or opioids in the last three months and have recently engaged in risky sexual behaviors, such as unprotected sex or receiving an STI diagnosis. Participants must be willing to provide urine samples and undergo HIV and STI testing. As an unphased trial, this study offers participants a chance to contribute to important public health research and potentially improve their own health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for people who use drugs?

Research shows that DESCOVY for PrEP, one of the treatments in this study, is generally safe for individuals without HIV. However, undiagnosed HIV can lead to drug resistance. It may also cause serious liver issues in those with hepatitis B. Common side effects, such as headaches or an upset stomach, are usually mild. Confirming HIV-negative status before starting DESCOVY is crucial.

APRETUDE has undergone testing in two clinical trials. The most common side effects include injection site reactions, diarrhea, headache, and tiredness. These occurred in at least 1% of participants and are mostly mild. APRETUDE is used to prevent HIV in individuals weighing at least 77 pounds.

Both treatments have shown to be well-tolerated with manageable side effects. Consulting a healthcare provider is essential to determine if PrEP is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines drug-checking services with PrEP (pre-exposure prophylaxis) for HIV prevention among people who use drugs (PWUD). Unlike traditional methods that focus solely on medication adherence, this approach includes an innovative harm-reduction strategy through drug-checking. This can empower individuals with information about the substances they are using, potentially reducing risky behaviors and enhancing the effectiveness of HIV prevention efforts. By integrating these services, the trial aims to address both immediate and long-term health needs, providing a more holistic approach to HIV prevention for this at-risk population.

What evidence suggests that this trial's treatments could be effective for overdose and HIV prevention among people who use drugs?

Research has shown that PrEP (pre-exposure prophylaxis) effectively prevents HIV. Studies found that over 99% of people who took DESCOVY, a type of PrEP, remained HIV-negative. Real-world studies of APRETUDE, a long-acting PrEP, also demonstrated more than 99% effectiveness. This indicates that PrEP reliably stops HIV before it starts, especially for high-risk individuals, such as those who use drugs. These findings suggest that using PrEP in the SCOPE Cohort of this trial could significantly reduce participants' risk of HIV. ^{6 7 8 9 10}

Who Is on the Research Team?

Susan Sherman, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Baltimore who use stimulants or opioids, have had unprotected sex recently, are HIV negative, and may have had an STI. They must be willing to undergo drug screening, HIV and STI testing. Those too impaired or unable to consent can't join.

Inclusion Criteria

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

Self-reports being HIV negative

Willing to undergo STI testing

Exclusion Criteria

Unwilling to provide all required biological specimens (Phase 3 only)

Unwilling/unable to give consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Drug Checking Technology Preparation

Calibration, validation, and piloting of drug-checking technology among PWUD

Varies

Intervention Implementation

Implementation of a community-level, mobile, integrated drug checking and PrEP intervention

18 months

4 visits (baseline, 6 months, 12 months, 18 months)

Follow-up

Participants are monitored for changes in PrEP uptake and HIV risk behaviors

18 months

Follow-up at 6-month intervals

What Are the Treatments Tested in This Trial?

Interventions

• CHECKIT!

Trial Overview The SCOPE study is evaluating a program that combines drug-checking services with PrEP (a medication preventing HIV) for people using drugs. The goal is to reduce both overdoses and new HIV infections among participants.

How Is the Trial Designed?

Group I: SCOPE Cohort Experimental Treatment 1 Intervention

A 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.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Baltimore City Health Department

Collaborator

Trials

9

Recruited

19,200+

Published Research Related to This Trial

Tenofovir/emtricitabine (Truvada) has been shown to be highly effective as preexposure prophylaxis (PrEP) for preventing HIV infection, with studies indicating excellent prevention when taken at least four times a week.

Despite its efficacy, challenges remain in the USA regarding awareness and acceptance of PrEP among at-risk individuals and healthcare providers, which are crucial for scaling up its use effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. Elion, R., Coleman, M.[2023]

Pre-exposure prophylaxis (PrEP), particularly using Truvada® (tenofovir disoproxil fumarate/emtricitabine), has been shown to effectively reduce the incidence of HIV infection among high-risk individuals, especially when combined with other preventive methods.

While PrEP has a good safety profile, with mild to moderate gastrointestinal side effects being the most common, regular monitoring of liver enzymes, renal function, and bone mineral density is essential to manage potential long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. Tetteh, RA., Yankey, BA., Nartey, ET., et al.[2022]

Two cases were reported where Tenofovir PrEP failed to prevent HIV acquisition in individuals with a history of adherence to the medication, highlighting the need for further investigation into its efficacy outside clinical trials.

In both cases, despite receiving Tenofovir, the patients developed acute HIV infections with significant viral loads, suggesting that Tenofovir may not effectively limit the viral reservoir during acute HIV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of daily tenofovir to prevent HIV transmission or the establishment of a significant viral reservoir despite continued antiretroviral therapy. Davies, O., Alexander, H., Robinson, N., et al.[2022]

Truvada is the only drug currently approved for the prevention of HIV infections, marking it as a crucial option in public health efforts against the virus.

As a key component of pre-exposure prophylaxis (PrEP), Truvada is designed to prevent HIV infection before exposure, rather than treating it after infection occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regimen Change: Gilead's TAF Drugs Toppling TDFs in HIV Treatment. Reinke, T.[2021]

A peri-coital regimen of Truvada (FTC and TDF) was shown to fully protect macaques from vaginal SHIV infection after 18 exposures, indicating its efficacy in preventing HIV transmission.

Despite lower concentrations of the drug in vaginal tissues compared to rectal tissues, the treatment was effective, suggesting that simplified PrEP regimens could be developed for women to prevent HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of vaginal SHIV transmission in macaques by a coitally-dependent Truvada regimen. Radzio, J., Aung, W., Holder, A., et al.[2021]

The Be-PrEP-ared study is evaluating the feasibility and acceptability of daily and event-driven PrEP among 200 high-risk men who have sex with men (MSM) in Belgium, aiming to inform optimal implementation of PrEP in the country.

This study will provide valuable insights into PrEP uptake, adherence, and its impact on sexual behavior, which will help shape national and European guidelines for HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis (PrEP) as an Additional Tool for HIV Prevention Among Men Who Have Sex With Men in Belgium: The Be-PrEP-ared Study Protocol. De Baetselier, I., Reyniers, T., Nöstlinger, C., et al.[2022]

Treatment as prevention is crucial for reducing HIV incidence, but additional prevention strategies, especially pre-exposure prophylaxis (PrEP), are necessary to effectively control the epidemic among key populations.

Despite the availability of oral PrEP with emtricitabine-tenofovir (Truvada®) in the US and other countries, its uptake has been slow due to various concerns, highlighting the need for ongoing research to improve acceptance and effectiveness of HIV prevention methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of oral pre-exposure prophylaxis (PrEP) in current and future HIV prevention strategies. Burns, DN., Grossman, C., Turpin, J., et al.[2021]

The study demonstrated that pre-exposure prophylaxis (PrEP) using Truvada is a highly effective strategy for preventing HIV infection among men who have sex with men, with strong retention and compliance rates observed during the study period from January 2017 to March 2021.

Safety assessments indicated that PrEP was well-tolerated, with no significant adverse events related to Truvada, and regular monitoring of renal function showed no major issues, supporting the safety of this preventive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. Terada-Hirashima, J., Mizushima, D., Takano, M., et al.[2023]

Citations

1. descovyhcp.com descovyhcp.com/discover-clinical-trial

99.7% remained HIV negative with DESCOVY ®1,2 Proven prevention with powerful results: 99.7% remained HIV negative with DESCOVY · DISCOVER is the largest PrEP clinical trial, with over 5300 participants ...

2. viivhealthcare.com viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/

ViiV Healthcare shows more than 99% effectiveness in real ... ViiV HEALTHCARE SHOWS MORE THAN 99% EFFECTIVENESS IN REAL-WORLD STUDIES FOR APRETUDE (CABOTEGRAVIR LONG-ACTING), THE ONLY APPROVED LONG-ACTING ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5935218/

Maximizing the Benefits of HIV Preexposure Prophylaxis In the PROUD study, 73% of participants had STIs at baseline and PrEP effectiveness was 86%. In the PrEP Demonstration Project, the incidence of STIs was 90 per ...

4. ahrq.gov ahrq.gov/data/visualizations/hiv-prep.html

Effectiveness of Pre-Exposure Prophylaxis To Prevent HIV ... The outcomes shown are HIV infection, mortality, and various other harms. The data are organized by the following study drugs and comparisons: oral PrEP ( ...

5. descovy.com descovy.com/about-descovy/clinical-trial-efficacy-results

Does DESCOVY for PrEP® Work? 99.7% of people stayed HIV-negative while on. DESCOVY for PrEP ® in a 2-year study. The DISCOVER trial recruited 5,000+ people. All study participants were ...

6. apretudehcp.com apretudehcp.com/safety/

safety established in 2 clinical trials The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep ...

7. apretude.com apretude.com/

Long-acting PrEP | APRETUDE (cabotegravir) APRETUDE is a prescription medicine used for HIV-1 PrEP to reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 77 pounds (at ...

8. descovy.com descovy.com/

DESCOVY for PrEP® (pre-exposure prophylaxis) Do not take DESCOVY for PrEP unless you are confirmed to be HIV-1 negative. DESCOVY does not prevent other sexually transmitted infections (STIs). Practice ...

9. viivexchange.com viivexchange.com/en-gb/hiv-medicines/apretude/safety/

APRETUDE▼ (cabotegravir) Safety Discover the safety data for APRETUDE. Learn about warnings and precautions, contraindications, drug interactions, adverse events and ISRs, usage during ...

10. descovyhcp.com descovyhcp.com/important-safety-information

Important Safety Information for DESCOVY FOR PrEP® | HCP Risk of drug resistance with use of DESCOVY FOR PrEP in undiagnosed early HIV-1 infection and post-treatment acute exacerbation of hepatitis B.