PrEPsmart + Truvada for HIV Prevention

Overseen By Juwann Moss

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Public Health Foundation Enterprises, Inc.

Must be taking: On-demand PrEP

Disqualifiers: Reactive HIV, Acute HIV symptoms, others

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

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to using Truvada, a medication that helps prevent HIV. The researchers aim to evaluate the effectiveness of a digital tool, PrEPsmart, for men who have sex with men, allowing them to take PrEP only when needed instead of daily. Participants will either use the PrEPsmart tool or continue their usual PrEP routine to compare results. Ideal participants are cisgender males who have anal sex at least once a month and are interested in starting or already taking on-demand PrEP. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does require that you have no contraindications (reasons not to take) to TDF/FTC, which is the medication used in the study.

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

Research has shown that Truvada, used to prevent HIV, is generally safe and well-tolerated. Most people experience few side effects, with mild nausea or headaches being the most common, and these usually resolve on their own. Serious side effects rarely occur.

The FDA has approved Truvada for preventing HIV, indicating a strong safety record. Prospective trial participants may find this information reassuring regarding its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PrEPsmart intervention because it could revolutionize how we approach HIV prevention. Unlike other treatments that simply provide medication, PrEPsmart integrates a digital app to enhance adherence and monitoring. This approach not only ensures participants have access to Truvada but also actively engages them in managing their own health through technology. By potentially increasing adherence and offering real-time support, PrEPsmart could set a new standard in preventive care for HIV.

What evidence suggests that the PrEPsmart intervention could be effective for HIV prevention?

Research shows that Truvada, when used as a preventive measure before exposure to HIV (known as PrEP), effectively stops the virus. Studies have found that it can lower the risk of contracting HIV by up to 99% if taken regularly. In this trial, participants in the PrEPsmart intervention arm will use the PrEPsmart program, designed to help people take Truvada correctly and consistently, which is key to its success. Although specific data on PrEPsmart is limited, the app aims to help users manage their PrEP routine better, potentially improving adherence. Regular use of PrEP like Truvada has a strong history of reducing HIV transmission in people at higher risk. ^{1 2 6 7 8}

Who Is on the Research Team?

Albert Liu

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for cisgender sexual minority males (SMM) who are interested in using a mobile app to help manage on-demand pre-exposure prophylaxis (PrEP) over six months. Participants should be men who have sex with men (MSM), but specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Able to attend study visits at a local research site in San Francisco (Bridge HIV) (prescribed and non-prescribed groups) or virtual visits via a HIPAA-compliant teleconferencing platform (non-prescribed group)

Have PrEP clinical and laboratory monitoring by another provider or clinic by self-report (non-prescribed group)

Owns an iOS or Android mobile phone with a camera and has private access to the internet

Exclusion Criteria

Unable to commit to study participation for the duration of the study

Currently enrolled in another PrEP intervention study

Repeatedly reactive HIV test at screening or enrollment or self-reported reactive HIV test (prescribed group)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment and Randomization

Participants are enrolled and randomized to either the PrEPsmart intervention or control group

1 week

1 visit (in-person or virtual)

Treatment

Participants receive the PrEPsmart app and are monitored for PrEP use and app usability

6 months

Follow-up visits at 3 and 6 months (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Truvada

Trial Overview The PrEPsmart pilot study is testing the use of a mobile app designed to support MSM taking Truvada as on-demand PrEP against HIV. The goal is to see if the app is easy to use, acceptable to participants, and effective at supporting medication management.

How Is the Trial Designed?

Group I: PrEPsmart intervention (N=40) Experimental Treatment 2 Interventions

Participants will be randomized in a 2:1 ratio to the intervention (N=40) For the pre-exposure prophylaxis (PrEP)smart intervention group, a study clinician will perform a medical history and limited physical exam to confirm eligibility to enroll in the study, a 4th generation rapid Human immunodeficiency virus (HIV) test will be performed, and labs drawn for creatinine, sexual transmitted infection (STI) testing (Neisseria gonorrhoeae/Chlamydia trachomatis (GC/CT)), syphilis), and hepatitis B testing. For participants newly starting 2-1-1 PrEP (PrEPsmart intervention group), study drug will be offered to participants to ensure that they will have access to PrEP during the study to be able to adequately test the app.

Group II: control (N=20) Active Control 1 Intervention

For the non-prescribed group, study staff will request documentation of an HIV-negative test within the last 3 months OR evidence of pre-exposure prophylaxis (PrEP) prescription within the last 6 months from medical records or pharmacy/provider communication. Additionally, study staff will confirm via self-report that the participant's 2-1-1 PrEP use will be clinically monitored by another clinician or clinic for the duration of the study. Any individual with a positive HIV test will have a confirmation test sent to the lab and be referred immediately for HIV care and initiation of treatment. For participants already on PrEP (control group) may choose to continue to use their own supply of Truvada (tenofovir disoproxil fumarate/emtricitabine, or TDF/FTC).

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

Approved in European Union as Truvada for:

• HIV pre-exposure prophylaxis

Approved in United States as Truvada for:

• HIV pre-exposure prophylaxis

Approved in Canada as Truvada for:

• HIV pre-exposure prophylaxis

Who Is Running the Clinical Trial?

Public Health Foundation Enterprises, Inc.

Lead Sponsor

Trials

15

Recruited

1,600+

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

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]

Tenofovir disoproxil fumarate-emtricitabine (TDF/FTC) has been approved for HIV pre-exposure prophylaxis (PrEP) since 2012, and while initial uptake was slow, recent surveys indicate growing acceptance among key populations.

Ongoing studies aim to improve PrEP implementation by identifying at-risk individuals in primary care settings and evaluating its use in HIV-discordant couples, highlighting the need for better education among healthcare providers and addressing financial barriers for underinsured patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiretroviral pre-exposure prophylaxis implementation in the United States: a work in progress. Mayer, KH., Hosek, S., Cohen, S., et al.[2022]

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]

Oral tenofovir disoproxil and emtricitabine (FTC) for HIV preexposure prophylaxis (PrEP) is generally safe and well tolerated, with common gastrointestinal side effects that typically resolve within weeks.

While there is a slight decline in kidney function (eGFR) and bone mineral density (BMD) associated with the treatment, these changes are not clinically significant and tend to resolve after stopping the medication, making it a viable option for most adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults. Liegeon, G.[2022]

Using tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for preexposure prophylaxis (PrEP) is effective in preventing HIV-1 infections, with resistance to the drugs being rare if PrEP is started before infection occurs.

However, starting PrEP during an undiagnosed acute HIV-1 infection can lead to higher rates of drug resistance, particularly to tenofovir, highlighting the importance of screening for HIV before initiating PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should we fear resistance from tenofovir/emtricitabine preexposure prophylaxis? Parikh, UM., Mellors, JW.[2018]

Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are effective in reducing the risk of HIV infection by 74 to 92% when taken as pre-exposure prophylaxis (PrEP) with detectable drug levels.

While TDF-FTC can cause side effects like nausea and decreased bone mineral density, these risks can be managed through regular monitoring by healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug safety evaluation of oral tenofovir disoproxil fumarate-emtricitabine for pre-exposure prophylaxis for human immunodeficiency virus infection. Trang, TP., Dong, BJ., Kojima, N., et al.[2017]

Tenofovir disoproxil fumarate (TDF) and its combination with emtricitabine (FTC), marketed as Truvada®, have been shown to be effective in preventing HIV infection when taken orally, either daily or intermittently, in various populations including men who have sex with men and serodiscordant couples.

Topical tenofovir gel has also demonstrated effectiveness in preventing HIV infection in women, highlighting the versatility of tenofovir-based interventions in HIV prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-exposure chemoprophylaxis of HIV infection: quo vadis? Clercq, ED.[2015]

The study found that the combination of emtricitabine and tenofovir alafenamide (F/TAF) was safe and well-tolerated among HIV-uninfected women, with significantly lower gastrointestinal side effects compared to the older F/TDF combination.

F/TAF demonstrated higher concentrations of the active form of tenofovir (TFV-DP) in peripheral blood mononuclear cells and vaginal tissues compared to F/TDF, suggesting it may be a more effective option for HIV pre-exposure prophylaxis in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Pharmacokinetics of a Tenofovir Alafenamide Fumarate-Emtricitabine based Oral Antiretroviral Regimen for Prevention of HIV Acquisition in Women: A Randomized Controlled Trial. Thurman, AR., Schwartz, JL., Cottrell, ML., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02895893?term=AREA%5BBasicSearch%5D(smart%20risk)&rank=4

Study Details | NCT02895893 | PrEP SMART Phase I Trial The goal of this Phase I study is to conduct a proof-of-concept trial of a contingency management (CM) targeting adherence to oral HIV antiretroviral pre- ...

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

Effectiveness of PrEPTECH: Findings From a 180-Day ... A trial of an online dyadic counseling intervention for HIV prevention did not find any significant gains in PrEP use among those randomized to ...

3. app.trialscreen.org app.trialscreen.org/trials/phase-2-prepsmart-1-pilot-trial-nct06631365

PrEPsmart 2-1-1 Pilot Study Participants in the intervention arm will have access to the innovative PrEPsmart app, designed to support the use of on-demand PrEP for HIV prevention.

4. thelancet.com thelancet.com/pdfs/journals/lanhiv/PIIS2352-3018(24)00268-6.pdf

Adaptive HIV pre-exposure prophylaxis adherence ... Pre-exposure prophylaxis (PrEP) is an effective. HIV-prevention intervention when used consistently during periods of HIV risk, but some ...

5. trialstoday.org trialstoday.org/trial/NCT06631365

PrEPsmart 2-1-1 Pilot Purpose. This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9177169/

Public Health Implications of Adapting HIV Pre-exposure ... We suggest a virtual service delivery model for PrEP that can be leveraged for COVID-19 using the internet and social media for demand creation.

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

Study protocol for an efficacy trial of the “PrEP for Health ... Co-primary outcomes are PrEP uptake (using medical/pharmacy records) and adherence (using tenofovir quantification in hair samples); a secondary ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8715511/

A Review of Recent HIV Prevention Interventions and ... Interventions targeting providers and care delivery increase risk screening, HIV testing, timely linkage to care, and PrEP access for eligible individuals.