100 Participants Needed

TelePrEP for HIV Prevention

AL
LA
Overseen ByLisa Abuogi
Age: < 65
Sex: Male
Trial Phase: Academic
Sponsor: University of Colorado, Denver
Must be taking: PrEP
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Youth represent the largest proportion of new HIV infections in Colorado, reflective of their inadequate access and uptake of pre-exposure prophylaxis(PrEP)for HIV prevention. Colorado's 2019 HIV/AIDS Prevention Program state-wide review of PrEP barriers showed PrEP eligible individuals do not access PrEP services due to lack of interest, not wanting referral to a navigator, and low estimation of HIV risk. The overall goal is to provide youth at higher risk for HIV with an effective youth informed telemedicine delivery of PrEP (TelePrEP) that addresses PrEP barriers and contributes to ending the HIV epidemic in Colorado. The primary objective will be proportion of youth retained on PrEP 12 months after initiation. The hypotheses are that a TelePrEP model for youth will be acceptable and feasible and will result in successful initiation, persistence and retention on oral PrEP.

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 data supports the effectiveness of the TelePrEP treatment for HIV prevention?

Research shows that PrEP, a daily medication, can reduce the risk of acquiring HIV by up to 97%. A study on a telemedicine program for PrEP found that it helped expand access to this effective prevention method, with high patient satisfaction and adherence to the medication.12345

Is TelePrEP for HIV prevention safe for humans?

Pre-exposure prophylaxis (PrEP), which includes the use of medications like tenofovir disoproxil fumarate/emtricitabine, has been shown to have a good safety profile in clinical trials. Common side effects are mild to moderate nausea, vomiting, and diarrhea, and regular monitoring is recommended to prevent long-term effects on liver, kidneys, and bones.12678

How is the TelePrEP treatment for HIV prevention different from other treatments?

TelePrEP is unique because it uses telemedicine to provide access to PrEP (Pre-Exposure Prophylaxis), allowing patients to receive HIV prevention medication remotely, which can increase accessibility for those who might not otherwise receive it.2391011

Eligibility Criteria

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
See 4 more

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • TelePrEP
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Telemedicine for pre-exposure prophylaxis of HIVExperimental Treatment1 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

Find a Clinic Near You

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 profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Findings from Research

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

References

Population-Level Effectiveness of HIV Pre-exposure Prophylaxis Among MSM and Transgender Persons With Bacterial Sexually Transmitted Infections. [2023]
Evaluation of a telemedicine pilot program for the provision of HIV pre-exposure prophylaxis in the Southeastern United States. [2023]
Integrating oral PrEP delivery among African women in a large HIV endpoint-driven clinical trial. [2021]
Missed opportunities to prevent HIV infections among pre-exposure prophylaxis users: a population-based mixed methods study, San Francisco, United States. [2023]
Iowa TelePrEP: A Public-Health-Partnered Telehealth Model for Human Immunodeficiency Virus Preexposure Prophylaxis Delivery in a Rural State. [2020]
[HIV preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine: What about safety?] [2022]
PrEP for HIV Prevention: Evidence, Global Scale-up, and Emerging Options. [2020]
Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]
To whom is HIV pre-exposure prophylaxis proposed? [2019]
Summary of German-Austrian HIV PrEP guideline. [2020]
Stampidine as a promising antiretroviral drug candidate for pre-exposure prophylaxis against sexually transmitted HIV/AIDS. [2013]