Pre-Exposure Prophylaxis for HIV Prevention

(MAPS PrEP Trial)

Overseen By Madelene Travis, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Disqualifiers: Positive HIV status

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether providing an oral medication called Pre-Exposure Prophylaxis (PrEP) via a medical van effectively prevents HIV in people at higher risk. The focus is on individuals who inject drugs or are sexually active, as these activities increase the chance of contracting HIV. Participants will receive PrEP pills to determine if this method effectively reduces their risk. Eligible individuals include those who actively inject drugs or are sexually active and are referred from a Syringe Service Program. People who are already HIV positive cannot participate. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications to join the trial?

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

What is the safety track record for Pre-Exposure Prophylaxis (PrEP)?

Research shows that Pre-Exposure Prophylaxis (PrEP) is safe for individuals without HIV who are at high risk of contracting it. Studies have found no major health issues in those using PrEP for up to five years. Reports from past research indicate no unusual safety problems for daily PrEP users. The most common side effects are mild, such as stomach upset and headaches. Overall, PrEP is well-tolerated and effectively prevents HIV infection. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about PrEP for HIV prevention because it offers a proactive approach to reducing HIV risk before exposure. Unlike traditional treatments that manage HIV after infection, PrEP involves taking oral pills regularly to prevent the virus from establishing an infection in the first place. This prevention strategy empowers individuals at high risk of HIV to take control of their health with a simple, daily medication. The goal is to significantly lower the chances of contracting HIV, making it a game-changer in the fight against the virus.

What is the effectiveness track record for Pre-Exposure Prophylaxis (PrEP) in preventing HIV?

Research has shown that Pre-Exposure Prophylaxis (PrEP), which participants in this trial will receive, is highly effective at preventing HIV. Studies have found that PrEP can lower the risk of contracting HIV from sex by about 99% when taken as directed. One study found it reduced the risk by 75% among men who have sex with men. Real-world evidence indicates that PrEP use can decrease the risk by 60% overall, and up to 93% with regular use. Consistent use of PrEP significantly reduces the chance of HIV infection. ^{6 7 8 9 10}

Who Is on the Research Team?

Jacqueline Hodges, MD, MPH

Principal Investigator

Duke Health

Mehri McKellar, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for individuals who inject drugs and/or are sexually active, putting them at a higher risk of contracting HIV. The study aims to provide oral HIV prevention medication via a medical van.

Inclusion Criteria

I am over 18, use drugs by injection, am sexually active, and was referred by a Syringe Service Program.

Exclusion Criteria

I am HIV positive.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Baseline

Treatment

Participants receive oral PrEP pills to reduce their risk for contracting HIV

6 months

Visits on a Medical Mobile Unit

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HIV status checks

6 months

3 month and 6 month visits

What Are the Treatments Tested in This Trial?

Interventions

• Pre-Exposure Prophylaxis (PrEP)

Trial Overview

The intervention being studied is the distribution of Pre-Exposure Prophylaxis (PrEP), an oral medication that helps prevent HIV infection, through a mobile medical service directly to high-risk populations.

How Is the Trial Designed?

Group I: PrEP Experimental Treatment 1 Intervention

All eligible participants will be given oral PrEP pills to reduce their risk for contracting HIV.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

The study demonstrated that pre-exposure prophylaxis (PrEP) using Truvada is a highly effective strategy for preventing HIV infection among men who have sex with men, with strong retention and compliance rates observed during the study period from January 2017 to March 2021.

Safety assessments indicated that PrEP was well-tolerated, with no significant adverse events related to Truvada, and regular monitoring of renal function showed no major issues, supporting the safety of this preventive approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Pre-Exposure Prophylaxis to Control HIV and Sexually Transmitted Infection Among Men Who Have Sex With Men: Protocol for a Single-Arm Interventional Study. Terada-Hirashima, J., Mizushima, D., Takano, M., et al.[2023]

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]

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]

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]

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]

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]

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]

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]

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Oral pre-exposure prophylaxis (PrEP) to prevent HIV

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The outcomes shown are HIV infection, mortality, and various other harms. The data are organized by the following study drugs and comparisons: oral PrEP ( ...

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cdc.gov

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Pre-Exposure Prophylaxis

Is PrEP Safe? PrEP is safe. No significant health effects have been seen in people who are HIV-negative and have taken PrEP for up to 5 years.

8.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK507789/

Preexposure Prophylaxis for HIV Prevention - StatPearls - NCBI

Preexposure prophylaxis (PrEP) is highly effective in preventing human immunodeficiency virus (HIV) and is an essential tool for decreasing HIV transmission in ...

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dph.illinois.gov

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Pre-Exposure Prophylaxis (PrEP)

PrEP is a way for people who do not have HIV, but who are at substantial risk of getting it, to prevent HIV infection by taking a pill every day.

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acog.org

acog.org/clinical/clinical-guidance/committee-opinion/articles/2014/05/preexposure-prophylaxis-for-the-prevention-of-human-immunodeficiency-virus

Preexposure Prophylaxis for the Prevention of Human ...

No unusual adverse effects or safety concerns were noted among HIV-negative participants taking daily tenofovir and emtricitabine. The most common adverse ...