TelePrEP for HIV Prevention

Overseen By Lisa Abuogi

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: PrEP

Disqualifiers: HIV infection, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if telemedicine effectively delivers pre-exposure prophylaxis (PrEP) for HIV prevention and appeals to youth in Colorado. It targets young people at higher risk for HIV who may not use PrEP due to barriers like low perceived risk or lack of interest. Participants will interact with healthcare providers through online or in-person visits to initiate and maintain PrEP treatment. Those who are HIV-negative, assigned male at birth, have recently had male sex partners, and are not in a monogamous relationship with an HIV-negative partner might be suitable candidates. The goal is to improve PrEP use and retention among this group. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions for HIV prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that TelePrEP is safe for youth?

Research shows that TelePrEP, a telemedicine method for providing pre-exposure prophylaxis (PrEP) to prevent HIV, has been safely used for HIV prevention. TelePrEP offers medications like Truvada, commonly used to reduce the risk of HIV infection in people without HIV.

Studies have found that when taken as directed, PrEP greatly lowers the chance of contracting HIV. A review of several studies revealed that people using PrEP had a much lower risk of HIV infection compared to those who did not use it, indicating that PrEP is effective and generally well-tolerated.

Although specific safety data for TelePrEP is limited, the telemedicine approach has successfully delivered PrEP without major safety issues, suggesting that the treatment is safe for those seeking to prevent HIV infection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TelePrEP for HIV prevention because it leverages telemedicine to make pre-exposure prophylaxis (PrEP) more accessible and convenient. Unlike traditional PrEP options, which often require multiple in-person visits to a healthcare provider, TelePrEP allows individuals to initiate and maintain their PrEP regimen remotely, either from home or a community organization. This approach can remove barriers to access, such as transportation and time constraints, making it easier for youth to receive timely care. Additionally, TelePrEP integrates rapid consenting and enrollment processes, offering same-day or expedited initiation of PrEP, which can be crucial in preventing HIV transmission among at-risk populations.

What evidence suggests that TelePrEP is effective for HIV prevention?

Research shows that telehealth services like TelePrEP, which participants in this trial will use, improve access to HIV prevention. One study found that digital tools for pre-exposure prophylaxis (PrEP) helped people adhere to their daily pills and remain in care. Another review highlighted that telehealth programs for PrEP, such as TelePrEP, provide a safe and effective way to access HIV prevention methods like Truvada. Additionally, data showed that people using telehealth completed lab tests at rates similar to those visiting clinics, indicating that TelePrEP is as effective as traditional methods. Overall, these findings suggest that TelePrEP is a promising way to increase PrEP use and keep young people at higher risk for HIV engaged in their care. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young individuals assigned male at birth, who have had male sex partners in the past 6 months and are HIV negative. They must be eligible for PrEP based on CDC guidance, agree to TelePrEP visits, and willing to use or obtain insurance coverage. It's not for pregnant individuals, those with HIV or acute HIV concerns until ruled out, cisgender women, transgender men, or persons whose only risk is from injection drug use.

Inclusion Criteria

I am a man who has had male partners recently and not in a monogamous relationship with an HIV-negative man.

I am eligible for PrEP with Descovy according to CDC guidelines.

HIV negative

Exclusion Criteria

Pregnancy

HIV-infection or concern for acute HIV infection until ruled out

I am at risk of HIV through vaginal sex and identify as a cisgender woman or transgender man.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual or in-person)

PrEP Initiation

Participants undergo a PrEP initiation visit with a provider, which may be in-person or via telemedicine. Recommended laboratory testing, including HIV testing, is conducted.

2 weeks

1 visit (virtual or in-person)

TelePrEP Follow-up

TelePrEP visits are conducted by a skilled multidisciplinary team one month after initiation and then every three months.

48 weeks

1 visit (virtual or in-person) every 3 months

Follow-up

Participants are monitored for retention on PrEP at week 48, including PrEP clinic visits or prescription refills.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TelePrEP

Trial Overview The study tests a telemedicine delivery of pre-exposure prophylaxis (TelePrEP) aimed at preventing HIV in youth. The goal is to see if this approach helps them start and stay on PrEP treatment over 12 months by overcoming barriers like lack of interest and low perceived risk.

How Is the Trial Designed?

Group I: Telemedicine for pre-exposure prophylaxis of HIV Experimental Treatment 1 Intervention

1. We will identify youth potentially eligibile for PrEP using tenfovir alefenamide/emtricitabine (TAF/FTC). 2. Eligible youth will be contacted for rapid (same day) consenting and enrollment. 3. Participants who consent to the study will undergo a PrEP initiation visit either the same day or within two weeks with a provider. The initial visit may be in-person or via Telemedicine. 4. TelePrEP visits may be carried out in the setting of the participant's choosing and may include home or at a community organization. 5. Recommended laboratory testing will be arranged as part of the PrEP initiation visit. HIV testing will be carried out as well as Centers for Disease Control and Prevention (CDC)-recommended laboratory testing will be obtained. 6. TelePrEP(or in-person visits as needed) will be conducted by a skilled multidisciplinary team one month after initiation and then every three months.

TelePrEP is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Truvada for:

• HIV prevention

Approved in European Union as Truvada for:

• HIV prevention

Approved in Canada as Truvada for:

• HIV prevention

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Published Research Related to This Trial

Antiretroviral pre-exposure prophylaxis (PrEP) using oral emtricitabine-tenofovir disoproxil fumarate has been proven effective and safe in preventing HIV infection, leading to regulatory approval in nearly 70 countries.

Ongoing development of next-generation PrEP formulations aims to simplify access and increase user choice, which could enhance coverage and further reduce HIV infection rates at the population level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PrEP for HIV Prevention: Evidence, Global Scale-up, and Emerging Options. Celum, C., Baeten, J.[2020]

The first German-Austrian PrEP guidelines provide comprehensive recommendations on the effective use of HIV Pre-Exposure Prophylaxis (PrEP) for individuals at risk, emphasizing its role in reducing HIV transmission.

The guidelines outline necessary laboratory tests and monitoring protocols to ensure safety and prevent adverse events while on PrEP, ensuring that healthcare providers have clear guidance for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Summary of German-Austrian HIV PrEP guideline. Spinner, CD., Lang, GF., Boesecke, C., et al.[2020]

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]

The Iowa TelePrEP program successfully provided HIV preexposure prophylaxis (PrEP) to clients in small urban and rural areas, with 91% of those who had video visits starting PrEP, demonstrating its efficacy in increasing access to this preventive treatment.

The program achieved a 61% retention rate at 6 months and effectively identified and treated 37 sexually transmitted infections (STIs), showcasing its ability to integrate comprehensive sexual health services alongside PrEP delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iowa TelePrEP: A Public-Health-Partnered Telehealth Model for Human Immunodeficiency Virus Preexposure Prophylaxis Delivery in a Rural State. Hoth, AB., Shafer, C., Dillon, DB., et al.[2020]

A study of 61 recent HIV seroconverted patients revealed that 98.4% were men who have sex with men, primarily aged 20 to 39 years, indicating a specific demographic that may benefit from PrEP.

The majority of these individuals engaged in high-risk behaviors, such as multiple unprotected sexual practices (82.7%) and substance use during sex (87%), highlighting the importance of targeted PrEP interventions for those at greatest risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To whom is HIV pre-exposure prophylaxis proposed? Ayerdi-Aguirrebengoa, O., Vera-García, M., Puerta-López, T., et al.[2019]

In the ECHO Trial, which involved 7830 women aged 16 to 35 from four African countries, integrating oral PrEP into the HIV prevention package was found to be practical and feasible, with 17.2% of eligible participants initiating PrEP after it became available.

Two-thirds of women who started PrEP continued using it until the end of the study, highlighting the potential for sustained PrEP use as part of comprehensive HIV prevention strategies in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial. Beesham, I., Welch, JD., Heffron, R., et al.[2021]

Pre-exposure prophylaxis (PrEP) can reduce the risk of acquiring HIV by up to 97%, and this 6-month telehealth study demonstrated that telemedicine can effectively provide access to PrEP for high-risk individuals, with 80% of the 20 enrolled participants completing the program.

Self-reported adherence to PrEP remained high (60%-70%) throughout the study, and a significant portion of participants (56.3%) preferred telemedicine for obtaining PrEP, indicating that telehealth can enhance access and comfort for patients seeking HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a telemedicine pilot program for the provision of HIV pre-exposure prophylaxis in the Southeastern United States. Player, MS., Cooper, NA., Perkins, S., et al.[2023]

A review of 808 cases of pre-exposure prophylaxis (PrEP) using TDF/FTC revealed that the most common adverse effects (AEs) were gastrointestinal issues, such as nausea, vomiting, and diarrhea, which aligns with known side effects in HIV-infected populations.

Despite identifying 24% of unexpected adverse effects, including serious ones primarily among chemsex users, the overall data supports the safety of PrEP, indicating it is a viable option for high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?] Jacomet, C., Lebeller, C., Schiestel, T., et al.[2022]

Stampidine is a novel antiretroviral drug candidate that shows strong effectiveness against multidrug-resistant HIV-1, with in vitro potency significantly higher than its required therapeutic levels, making it a promising option for pre-exposure prophylaxis (PrEP).

In preclinical studies, stampidine demonstrated a favorable safety profile, with no observed toxicity in various animal models and no dose-limiting toxicity in a Phase I clinical trial involving human participants, indicating its potential for safe use in preventing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stampidine as a promising antiretroviral drug candidate for pre-exposure prophylaxis against sexually transmitted HIV/AIDS. Uckun, FM., Cahn, P., Qazi, S., et al.[2013]

In a study of 4368 individuals at increased risk of HIV in King County, Washington, self-reported PrEP use was linked to a 79% reduction in HIV incidence, with only 0.4% of PrEP users diagnosed with HIV compared to 3% of nonusers.

The study found that PrEP users had an HIV incidence rate of 0.17 cases per 100 person-years, significantly lower than the 1.86 cases per 100 person-years in nonusers, highlighting the effectiveness of PrEP in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population-Level Effectiveness of HIV Pre-exposure Prophylaxis Among MSM and Transgender Persons With Bacterial Sexually Transmitted Infections. Pagkas-Bather, J., Khosropour, CM., Golden, MR., et al.[2023]

HIV incidence was found to be 7.5 times higher after individuals stopped using PrEP compared to when they were on it, highlighting the importance of continuous adherence to PrEP for effective HIV prevention.

Barriers to maintaining PrEP included substance use, mental health issues, and difficulties accessing the medication, suggesting that targeted outreach and education could help improve adherence and prevent HIV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Missed opportunities to prevent HIV infections among pre-exposure prophylaxis users: a population-based mixed methods study, San Francisco, United States. Spinelli, MA., Laborde, N., Kinley, P., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10927298/

Effectiveness of PrEPTECH: Findings From a 180-Day ... This randomized controlled trial of PrEPTECH, a telehealth intervention for the provision of HIV PrEP, seeks to assess its effects on PrEP access.

2. teleprep.org teleprep.org/prep/

Teleprep is a safe sex program available now online TelePrEP is a safe sex program that provides Truvada as an HIV prevention method for individuals in the Texas and New Mexico region.

3. link.springer.com link.springer.com/article/10.1007/s10461-024-04366-3

Telehealth Models for PrEP Delivery: A Systematic Review ... This study presents a systematic review of telePrEP programs in the US, aiming to describe model characteristics and summarize clinical, implementation, and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379724000631

Digital HIV Pre-Exposure Prophylaxis Interventions This systematic review found that digital PrEP adherence interventions improved both daily-use pill taking and retention in PrEP care.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10668045/

Evaluation of the Impact and Outcomes of a Rapid ... Also, there were no significant differences in lab completion rates between in-clinic (n=140/140) and telePrEP clients (n=138/143) (P=0.06) and prescription ...

6. lgbtqiahealtheducation.org lgbtqiahealtheducation.org/wp-content/uploads/2021/07/TelePrEP-Brief.pdf

Telemedicine for HIV Prevention Pre-exposure prophylaxis (PrEP) for HIV refers to the use of antiretroviral medication by people without HIV to prevent acquiring the infection through sex ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S277306542500121X

HIV Pre-Exposure Prophylaxis Care Continuum in ... The 34 studies were comprised of 71,162 individuals eligible for PrEP. Among them, 66% had increased HIV risk awareness, 55% had enhanced PrEP ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2808515

Preexposure Prophylaxis for the Prevention of HIV ... Eleven trials in the 2019 review found oral PrEP associated with decreased HIV infection risk vs placebo or no PrEP (n = 18 172; relative risk [RR], 0.46 [95% ...