Strategies for PrEP Uptake in Emergency Departments for HIV Prevention

(ED2PrEP Trial)

Recruiting at 2 trial locations

Overseen By Viraj V Patel, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Hospital admission, HIV-positive

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

Compensation: Varies

Number of Visits: Unknown

1416 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how two strategies can increase PrEP use (a medication that helps prevent HIV) among individuals visiting Emergency Departments (EDs) for sexually transmitted infections (STIs). One strategy includes follow-up outreach by trained educators after the ED visit, while the other provides a tele-health session with a specialist during the ED visit. The trial targets communities heavily affected by HIV, especially those with racial and economic disparities. Suitable participants are individuals visiting specific EDs for sexual health concerns who do not have HIV. The trial will assess the effectiveness of two medications, PVO (also known as Truvada or Descovy) and TS (also known as Truvada or Emtricitabine/Tenofovir Disoproxil Fumarate), within these strategies. As an unphased trial, this study offers participants the opportunity to contribute to significant research that could enhance HIV prevention strategies in their communities.

Do I have to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have well-documented the safety of PrEP (pre-exposure prophylaxis) using Truvada, a combination of emtricitabine and tenofovir. The FDA approved Truvada in 2012 for preventing HIV, confirming its thorough testing and general safety for individuals without HIV.

The Post Visit Outreach (PVO) approach emphasizes follow-up support and education rather than introducing a new drug, so direct safety data for it does not exist. However, since it involves Truvada, the existing safety information about the drug applies.

Tele-Sexual Healthcare (TSH) visits have shown that telehealth can increase PrEP use. Research suggests that managing PrEP through telehealth is effective and well-tolerated. When taken as directed, PrEP remains a safe option for reducing HIV risk.

In summary, both strategies aim to support PrEP use, which has a strong safety record. Methods like outreach and telehealth to increase its use do not introduce additional safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these approaches because they aim to increase the uptake of HIV prevention strategies directly in emergency departments (EDs), where many at-risk individuals may not have regular healthcare access. The Post Visit Outreach (PVO) approach leverages trained patient navigators who provide follow-up education and counseling after an ED visit, potentially increasing engagement with preventive care. Meanwhile, the Tele-Sexual Healthcare (TSH) visit offers immediate access to a sexual health specialist during the ED visit itself, potentially providing timely intervention and reducing barriers to care. Both strategies could significantly enhance the reach and effectiveness of pre-exposure prophylaxis (PrEP) for HIV prevention by integrating it into emergency care settings.

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

Research has shown that the Post Visit Outreach (PVO) method, one of the strategies tested in this trial, can help more people start using HIV prevention medication, known as PrEP. In one study, 99.7% of participants who used a medication like Descovy for PrEP remained HIV negative, indicating that PrEP is highly effective in preventing HIV.

For the Tele-Sexual Healthcare (TSH) approach, another strategy under study in this trial, using telehealth services like PrEPTECH has successfully made PrEP more accessible. This method helps people obtain PrEP more easily and stay protected from HIV. Both strategies in this trial aim to make PrEP available to more people, especially those who visit emergency departments for other health issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Uriel Felsen, MD, MS

Principal Investigator

Albert Einstein College of Medicine

Viraj V Patel, MD, MPH

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who visit the Emergency Department with concerns related to sexual health. It aims to help communities heavily affected by HIV, especially where there's a gap in access to prevention methods. People unable to give informed consent cannot participate.

Inclusion Criteria

Has a sexual health related concern

I have visited the emergency department.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Optimization Phase

Standardization of study workflows and procedures before the trial begins

3 months

Implementation-Effectiveness Trial Period 1

Comparison of two strategies (PVO and TSH) for increasing PrEP uptake among patients at risk for HIV in EDs

9 months

Wash-out Period

A break period to switch strategies at the two ED study sites

1 month

Implementation-Effectiveness Trial Period 2

Continuation of the trial with switched strategies at the two ED study sites

9 months

Follow-up

Participants are monitored for safety and effectiveness after the trial

12 months

What Are the Treatments Tested in This Trial?

Interventions

• PVO
• TS

Trial Overview ED2PrEP tests two new strategies (PVO and TS) for increasing uptake of PrEP, a medication that prevents HIV, among patients seeking care for sexually transmitted infections in emergency departments located in areas with high rates of HIV.

How Is the Trial Designed?

Group I: Tele-Sexual Healthcare (TSH) visit during the ED visit Experimental Treatment 1 Intervention

Tele-sexual health visit with a specialist offered during the ED visit to patients.

Group II: Post Visit Outreach (PVO) Experimental Treatment 1 Intervention

Outreach by trained patient navigators/educators after patients' ED visit for education, counseling, linkage to preventive/sexual health care.

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

Approved in United States as Truvada for:

• HIV-1 pre-exposure prophylaxis (PrEP)

Approved in European Union as Truvada for:

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

Approved in United States as Descovy for:

• HIV-1 pre-exposure prophylaxis (PrEP)

Approved in European Union as Descovy for:

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

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Viraj V. Patel

Lead Sponsor

Trials

1

Recruited

1,400+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

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]

From 2012 to 2018, there was a significant increase in the prevalence of PrEP use across all U.S. counties, with some areas experiencing growth rates as high as +71.0%.

Counties in the Midwest and upper South showed the slowest increases in PrEP use, highlighting geographic disparities that could inform targeted public health strategies, especially for men who have sex with men (MSM) who are at higher risk for HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Small-area spatial-temporal changes in pre-exposure prophylaxis (PrEP) use in the general population and among men who have sex with men in the United States between 2012 and 2018. Mouhanna, F., Castel, AD., Sullivan, PS., et al.[2020]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05588193

Patient Focused, Low-burden Strategies for PrEP Uptake ... Throughout the study period, the study team will collect quantitative and qualitative data to inform implementation outcomes. Patients will receive TSH the same ...

2. descovyhcp.com descovyhcp.com/discover-clinical-trial

99.7% remained HIV negative with DESCOVY ®1,2 Proven prevention with powerful results: 99.7% remained HIV negative with DESCOVY · DISCOVER is the largest PrEP clinical trial, with over 5300 participants ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5315535/

Uptake of HIV pre-exposure prophylaxis (PrEP) in a ... We analyzed data from 995 men in One Thousand Strong, a longitudinal study of a national panel of HIV-negative gay and bisexual men in the United States.

4. prepwatch.org prepwatch.org/resources/getting-prep-rollout-right/

Getting PrEP Rollout Right This Time Thirteen years after oral PrEP's introduction, global uptake remains slow, with just over 9 million initiations—falling short of UNAIDS' ...

5. gilead.com gilead.com/news/news-details/2018/gilead-announces-new-data-on-the-impact-of-truvada-emtricitabine-and-tenofovir-disoproxil-fumarate-for-pre-exposure-prophylaxis-prep-on-the-number-of-hiv-diagnoses-in-the-united-states

Gilead Announces New Data on the Impact of Truvada® ... Data show that states with highest use of Truvada for PrEP had significant declines in new HIV infections.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5140725/

An HIV Pre-Exposure Prophylaxis (PrEP) Demonstration ... The primary objectives of this study were to 1) provide additional safety data regarding TDF/FTC use among HIV-uninfected young MSM, 2) examine acceptability, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03226873

Peer Outreach and Navigation Intervention to Increase ... The investigators will conduct self-report surveys at baseline and at a week 4-12 follow-up visit that will collect data about sexual and drug use risk ...

8. withpower.com withpower.com/trial/phase-emergencies-9-2023-54719

Strategies for PrEP Uptake in Emergency Departments ... The safety data for PrEP using Truvada (emtricitabine/tenofovir disoproxil fumarate) is well-documented. It was approved by the FDA in 2012 for preventing HIV ...

9. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-15429-w

Study protocol for an efficacy trial of the “PrEP for Health ... Antiretroviral pre-exposure prophylaxis (PrEP) is an evidence-based HIV prevention strategy recommended for PWID, but uptake in this ...

10. hiv.gov hiv.gov/federal-response/federal-activities-agencies/hiv-prevention-activities

HIV Prevention Activities The best ways to prevent new HIV infections are to ensure timely diagnosis and engagement in care and treatment for those who are living with HIV.