Telehealth for HIV Prevention
(CHARIOT Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Must not be taking: MOUD, PrEP
Disqualifiers: Reactive HIV, Prison, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to test 2 different ways to offer medications to prevent human immunodeficiency virus (HIV), cure hepatitis C virus (HCV) (if applicable) and treat substance use disorder (if desired) in people who inject drugs.
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).
Is the telehealth treatment for HIV prevention safe for humans?
The combination of emtricitabine and tenofovir disoproxil fumarate, also known as Truvada, has been used safely for HIV prevention in adults. It is generally well-tolerated and free of short-term irritating toxicity.
12345How is the drug Truvada unique for HIV prevention?
Truvada is unique for HIV prevention because it is used as a pre-exposure prophylaxis (PrEP), meaning it is taken before potential exposure to HIV to prevent infection. It combines two drugs, emtricitabine and tenofovir disoproxil fumarate, into a single daily pill, making it convenient for high-risk individuals.
13678Eligibility Criteria
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
I am 18 years old or older.
Willing and able to sign informed consent, provide locator information and medical records release
Planning to stay in the area for 12 months
+3 more
Exclusion Criteria
Reactive HIV test
Currently on medications for opioid use disorder (MOUD)
Principal or site investigator discretion
+3 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Comprehensive Tele-harm ReductionExperimental Treatment1 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 preventionActive Control1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
IDEA MiamiMiami, FL
IDEA Syringe Services ProgramMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Preexposure prophylaxis: An emerging clinical approach to preventing HIV in high-risk adults. [2015]The HIV antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (Truvada) was recently approved as preexposure prophylaxis (PrEP) therapy for adults at high risk for sexually acquired HIV infection. This article reviews the data supporting the efficacy of PrEP, and provides other relevant data regarding the implementation of PrEP.
First year of pre-exposure prophylaxis implementation in France with daily or on-demand tenofovir disoproxil fumarate/emtricitabine. [2020]In January 2016, the French Medicine Agency initiated a Temporary Recommendation for Use (TRU) to allow the use of oral intake of tenofovir disoproxil fumarate and emtricitabine for pre-exposure prophylaxis (PrEP) in adults at high risk of HIV. We report the results of the first year of PrEP implementation in France.
Use of tenofovir disoproxil fumarate and emtricitabine combination in HIV-infected patients. [2019]With the continuing spread of HIV infection, particularly in developing countries, cost-effective treatment for its management is a high priority. Truvada (Gilead Sciences) is a single combination pill of the nucleotide reverse transcriptase inhibitors tenofovir disoproxil fumarate and emtricitabine, which is used once daily. It is anticipated to be a clinically potent combination that is free of short-term irritating toxicity. The drug has recently been licensed but there are currently little clinical efficacy data regarding its use. The limited published data have indicated that emtricitabine and lamivudine have equivalent potency, and randomised controlled trials have produced evidence of the efficacy of lamivudine combined with tenofovir disoproxil fumarate in a regimen containing either the non-nucleoside reverse transcriptase inhibitor efavirenz or a protease inhibitor lopinavir/ritonavir. In these trials, long-term durability data are available for
PrEParing for Preexposure Prophylaxis. [2021]In 2012 the Food and Drug Administration (FDA) approved Truvada (emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) for preexposure prophylaxis (PrEP) against HIV. There was a substantial decline in new HIV diagnoses which has since stabilized.
Safety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults. [2022]This review focuses on the safety of oral tenofovir disoproxil and emtricitabine (FTC) combination for HIV preexposure prophylaxis (PrEP) in adults.
HIV Pre-Exposure Prophylaxis - Is it just about pills? [2017]The increasing use of antiretrovirals for averting HIV infection before potential exposure is under debate. Whereas there is no doubt about the benefit of using Truvada® (tenofovir plus emtricitabine) to reduce HIV acquisition in uninfected persons who have sex with HIV-infected stable partners, concerns are rising about the increasing rate of sexually transmitted infections in subjects engaged in sex with multiple partners, due to misinterpreted self-security.
Role of oral pre-exposure prophylaxis (PrEP) in current and future HIV prevention strategies. [2021]Treatment as prevention is expected to have a major role in reducing HIV incidence, but other prevention interventions will also be required to bring the epidemic under control, particularly among key populations. One or more forms of pre-exposure prophylaxis (PrEP) will likely play a critical role. Oral PrEP with emtricitabine-tenofovir (Truvada®) is currently available in the US and some other countries, but uptake has been slow. We review the concerns that have contributed to this slow uptake and discuss current and future research in this critical area of HIV prevention research.
Prevention of vaginal SHIV transmission in macaques by a coitally-dependent Truvada regimen. [2021]Daily pre-exposure prophylaxis (PrEP) with Truvada (a combination of emtricitabine (FTC) and tenofovir (TFV) disoproxil fumarate (TDF)) is a novel HIV prevention strategy recently found to prevent HIV transmission in men who have sex with men and heterosexual couples. We previously showed that a coitally-dependent Truvada regimen protected macaques against rectal SHIV transmission. Here we examined FTC and tenofovir TFV exposure in vaginal tissues after oral dosing and assessed if peri-coital Truvada also protects macaques against vaginal SHIV infection.