Telehealth for HIV Prevention

(CHARIOT Trial)

Recruiting at 1 trial location

Overseen By Hansel Tookes, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: MOUD, PrEP

Disqualifiers: Reactive HIV, Prison, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of delivering medication to prevent HIV, cure hepatitis C, and treat substance use disorder in people who inject drugs. One method involves community engagement, while the other offers enhanced access to healthcare professionals through video calls, allowing participants to connect from comfortable locations like home or shelters. The trial suits individuals who have used syringe exchange programs at least twice in the past three months and plan to remain in the area for the next year. As an unphased trial, it allows participants to contribute to innovative healthcare solutions tailored to their needs.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on medications for opioid use disorder or PrEP (pre-exposure prophylaxis for HIV).

What prior data suggests that this telehealth method is safe for HIV prevention?

Research has shown that telehealth for HIV prevention is safe. Studies on medicines like Truvada (emtricitabine/tenofovir) indicate they are well-tolerated. Participants using these medicines for HIV prevention have not reported major side effects. A safety review found no increased risk of problems during pregnancy or with early infant growth when using these medicines.

In this trial, telehealth connects participants with doctors and psychologists. This method, combined with proven safe medicines, aims to prevent HIV, cure hepatitis C, and treat substance use disorder. The goal is to make it easier for those at risk to safely access the care they need. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Telehealth for HIV Prevention trial because it explores new ways to deliver HIV and harm prevention services. Unlike traditional care, which often requires in-person visits to clinics, this approach uses telehealth to provide comprehensive care via remote video technology. This method can reach people wherever they are, whether at home, in shelters, or in other settings, making it especially beneficial for those with limited access to healthcare facilities. Additionally, the trial includes off-site linkage to HIV care, offering case management and social work services to ensure participants receive consistent support. This innovative approach could make HIV prevention more accessible and effective for a wider range of individuals.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research has shown that taking daily pre-exposure prophylaxis (PrEP) effectively prevents HIV. Studies have found that the medication Truvada® significantly lowers the risk of contracting HIV when taken regularly. PrEP has proven effective in both clinical trials and everyday life, making it a reliable choice for HIV prevention. This trial includes a treatment arm where participants receive comprehensive tele-harm reduction, using telehealth to enhance access to doctors and psychologists via video calls. This approach aims to facilitate access to preventive treatments and improve adherence and outcomes, particularly for those who inject drugs. Another arm of the trial involves off-site linkage to HIV prevention, where participants receive case management and social work services through a community engagement team. ^{3 6 7 8 9}

Who Is on the Research Team?

Hansel Tookes

Principal Investigator

University of Miami

Tyler Bartholomew, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who use syringe services and plan to stay local for a year. They must test negative for HIV, not be on opioid meds or HIV prevention drugs, and can't be in jail or other trials.

Inclusion Criteria

Willing and able to sign informed consent, provide locator information and medical records release

Planning to stay in the area for 12 months

I have used a syringe service program twice in the last 3 months.

Exclusion Criteria

Reactive HIV test

Currently on medications for opioid use disorder (MOUD)

Principal or site investigator discretion

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either off-site linkage to HIV care or comprehensive tele-harm reduction services for 12 months

12 months

Remote video technology engagement

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive HIV and Harm Prevention Via Telehealth

Trial Overview The study tests two methods of delivering medications to prevent HIV, possibly cure HCV, and treat substance use if desired—all through telehealth services aimed at people who inject drugs.

How Is the Trial Designed?

Group I: Comprehensive Tele-harm Reduction Experimental Treatment 1 Intervention

Participants will have enhanced access to a physician and clinical psychologist via remote video technology wherever the participant is located and prefers engagement (SSP, home, shelter, encampment). Participants will be in this group for 12 months.

Group II: Off-site Linkage to HIV prevention Active Control 1 Intervention

Participants in this group will receive off-site linkage to HIV care by having case management/social work services through our community engagement team. Participants will be in this group for 12 months.

Comprehensive HIV and Harm Prevention Via Telehealth is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Truvada for:

• HIV-1 infection
• Pre-exposure prophylaxis (PrEP)

Approved in United States as Truvada for:

• HIV-1 infection
• Pre-exposure prophylaxis (PrEP)

Approved in Canada as Truvada for:

• HIV-1 infection
• Pre-exposure prophylaxis (PrEP)

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In the first year of PrEP implementation in France, 3405 subjects were enrolled, primarily men who have sex with men (MSM), with 57% receiving an on-demand regimen, indicating a strong uptake of this preventive measure.

Only four breakthrough HIV infections occurred during the study, suggesting that PrEP is effective and safe, particularly when adherence is maintained, as these infections were linked to interruptions in PrEP use or acute infections at the start of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First year of pre-exposure prophylaxis implementation in France with daily or on-demand tenofovir disoproxil fumarate/emtricitabine. Siguier, M., Mera, R., Pialoux, G., et al.[2020]

Oral tenofovir disoproxil and emtricitabine (FTC) for HIV preexposure prophylaxis (PrEP) is generally safe and well tolerated, with common gastrointestinal side effects that typically resolve within weeks.

While there is a slight decline in kidney function (eGFR) and bone mineral density (BMD) associated with the treatment, these changes are not clinically significant and tend to resolve after stopping the medication, making it a viable option for most adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults. Liegeon, G.[2022]

Truvada® (tenofovir plus emtricitabine) is effective in reducing the risk of HIV infection in uninfected individuals who have stable sexual partners with HIV.

There is a growing concern that the use of Truvada® may lead to an increase in sexually transmitted infections among individuals with multiple partners, as they may develop a false sense of security regarding their sexual health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Pre-Exposure Prophylaxis - Is it just about pills? Fernandez-Montero, JV.[2017]

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]

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]

Truvada (FTC/TDF) is an effective preexposure prophylaxis (PrEP) for HIV, but only a small fraction of the 1.2 million adults who could benefit from it are currently using it, highlighting a gap in preventative care.

The article emphasizes the importance of primary care providers (PCPs) in discussing and prescribing PrEP, aiming to enhance their confidence in managing patient care for high-risk groups to further reduce HIV incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEParing for Preexposure Prophylaxis. Zappas, MP., Foreman, RM.[2021]

Emtricitabine/tenofovir disoproxil fumarate (Truvada) has been approved as an effective preexposure prophylaxis (PrEP) therapy for adults at high risk of acquiring HIV through sexual contact.

The article reviews data that supports the efficacy of PrEP, highlighting its role in preventing HIV infection in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. Blackwell, CW.[2015]

Truvada, a once-daily combination pill containing tenofovir disoproxil fumarate and emtricitabine, is expected to be an effective and low-toxicity treatment option for managing HIV, especially in developing countries.

While there is limited clinical efficacy data available, existing studies suggest that emtricitabine is as potent as lamivudine, and trials have shown that tenofovir combined with lamivudine is effective when paired with other antiretroviral medications for up to 96 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of tenofovir disoproxil fumarate and emtricitabine combination in HIV-infected patients. Gazzard, BG.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687690/

Efficacy and Safety of Pre-Exposure Prophylaxis to Control ... The findings indicated that PrEP is a highly effective and feasible strategy against HIV infection in terms of prophylactic response, retention, and compliance.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6453722/

Review of real-world implementation data on emtricitabine ... This review examines data on the implementation of PrEP outside the setting of clinical trials with the aim of providing clinicians with a summary of the ...

3. nature.com nature.com/articles/s41598-018-33524-6

Daily HIV pre-exposure prophylaxis (PrEP) with tenofovir ... Daily PrEP is highly effective at preventing HIV-1 acquisition, but risks of long-term tenofovir disoproxil fumarate plus emtricitabine ...

4. everlywell.com everlywell.com/blog/virtual-care/how-effective-is-truvada-in-preventing-hiv/?srsltid=AfmBOoqGM86sE5Cps6aUSwcCC9H46pl32P-eEQa-OJwMInJOOu0U6VCU

How effective is Truvada® in preventing HIV? Wondering how effective Truvada® is for preventing HIV? Find out the answer here, including key statistics from clinical studies.

5. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2012/021752Orig1s030MedR.pdf

021752Orig1s030 - accessdata.fda.gov Both trials demonstrated the superiority of once-daily oral. TRUVADA over placebo in preventing HIV acquisition through sexual exposure when offered as part of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00458393

Study Details | NCT00458393 | Emtricitabine/Tenofovir ... This study will evaluate the safety and efficacy of chemoprophylaxis for HIV prevention in men who have sex with men (MSM) who are at high risk for HIV ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02213328

Acceptability, Safety, and Use of Daily Truvada Pre- ... The purpose of this study is to evaluate the acceptability, safety, and use of daily Truvada PrEP as part of a comprehensive HIV prevention package.

8. ctv.veeva.com ctv.veeva.com/study/comprehensive-hiv-and-harm-prevention-via-telehealth

Comprehensive HIV and Harm Prevention Via Telehealth The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9010110/

Safety review of tenofovir disoproxil fumarate/emtricitabine ... The current evidence indicates that TDF/FTC PrEP use is not associated with increased risk of adverse pregnancy and early infant growth outcomes.