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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug Truvada for HIV prevention?

Research shows that Truvada, a combination of emtricitabine and tenofovir, is effective in preventing HIV transmission among high-risk individuals, such as men who have sex with men and heterosexual couples. It has been shown to protect against HIV in both clinical trials and real-world settings when used as pre-exposure prophylaxis (PrEP). ^{1 2 3 4 5}

Is PrEP safe for humans?

PrEP, which includes drugs like Truvada, has been shown to be generally safe in humans, with mild to moderate side effects such as nausea, vomiting, and diarrhea. Regular monitoring is recommended to prevent long-term effects on liver, kidneys, and bones. ^{1 3 5 6 7}

How does the drug-checking services combined with PrEP for HIV prevention differ from other treatments?

This treatment is unique because it combines drug-checking services with pre-exposure prophylaxis (PrEP) using Truvada, which is a preventive approach rather than a treatment for HIV. Truvada, a combination of emtricitabine and tenofovir, is taken by people who are not infected with HIV to prevent infection, and the addition of drug-checking services aims to enhance safety and adherence to the regimen. ^{1 2 4 7 8}

Research Team

Susan Sherman, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prevention of vaginal SHIV transmission in macaques by a coitally-dependent Truvada regimen. [2021]

2. Switzerland 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. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Role of oral pre-exposure prophylaxis (PrEP) in current and future HIV prevention strategies. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. [2023]

6. Canada 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. [2022]

7. Canada 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Regimen Change: Gilead's TAF Drugs Toppling TDFs in HIV Treatment. [2021]