Strategies for PrEP Uptake in Emergency Departments for HIV Prevention

(ED2PrEP Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

Severe inequities in HIV pre-exposure prophylaxis (PrEP) access and use in communities hardest hit by the HIV epidemic persist, further exacerbating ongoing racial/ethnic and socioeconomic disparities in HIV incidence. In these same communities, many patients at risk for HIV seek care for sexually transmitted infections (STIs) in Emergency Departments (EDs), but the structure of traditional ED care is poorly suited to address HIV prevention or provide PrEP. To advance the Prevent objective of the Ending the HIV Epidemic (EHE) initiative, ED2PrEP will leverage an implementation science approach to rigorously test two innovative strategies for increasing PrEP uptake among patients seeking STI care in EDs in one of the 48 EHE-identified geographic hotspots.

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.

What data supports the idea that the drug Strategies for PrEP Uptake in Emergency Departments for HIV Prevention is an effective treatment?

The available research shows that the drug Truvada, which is used for HIV prevention, has been effective in reducing new HIV diagnoses. For example, after its approval in 2012, there was a significant decline in new HIV cases. Additionally, studies have demonstrated that Truvada can prevent HIV transmission in both men who have sex with men and heterosexual couples. This suggests that Truvada is a reliable option for preventing HIV in high-risk individuals. ^{1 2 3 4 5}

What safety data exists for PrEP using Truvada or similar treatments?

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 in high-risk adults. Studies have shown its efficacy in reducing HIV transmission among men who have sex with men, heterosexual couples, and in animal models. The implementation of PrEP in France and the U.S. has been monitored, showing a decline in new HIV diagnoses and widespread use. Safety and efficacy data support its use as a preventive measure. ^{1 2 3 6 7}

Is the drug PVO, TS (Truvada, Descovy) a promising option for preventing HIV in emergency departments?

Yes, the drug Truvada, which is part of the PVO, TS treatment, is promising for preventing HIV. It has been shown to reduce new HIV infections significantly and is used as a preventive measure for people at high risk of HIV exposure. ^{1 2 3 4 6}

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

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prevention of vaginal SHIV transmission in macaques by a coitally-dependent Truvada regimen. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

PrEParing for Preexposure Prophylaxis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

The preexposure prophylaxis revolution: from clinical trials to routine practice: implementation view from the USA. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

HIV Pre-Exposure Prophylaxis - Is it just about pills? [2017]

6. England pubmed.ncbi.nlm.nih.gov

First year of pre-exposure prophylaxis implementation in France with daily or on-demand tenofovir disoproxil fumarate/emtricitabine. [2020]

7. United States 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. [2020]