PrEP Information Strategies for HIV Prevention

Overseen By Jessica Myrick, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to share information about PrEP (pre-exposure prophylaxis), a treatment to prevent HIV, through online content. It tests different messaging strategies for both injectable and oral PrEP to determine which are most engaging. Researchers will study participants' browsing and eye movements as they view mock Google search results. The trial seeks young men, ages 18–34, who identify as cisgender male, gay, or bisexual, are HIV negative, and have had anal sex in the last 6 months, particularly those with an HIV-positive partner, inconsistent condom use, or a recent STI diagnosis. As an unphased trial, this study allows participants to contribute to innovative strategies for HIV prevention education.

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 prior data suggests that these health communication strategies are safe?

Research has shown that both injectable and oral PrEP (pre-exposure prophylaxis) are generally safe. For injectable PrEP, which includes the drug APRETUDE, studies with over 3,500 participants indicated it was well-tolerated. Common side effects included reactions at the injection site, diarrhea, headache, fever, and tiredness, but these were usually mild.

For oral PrEP, such as DESCOVY, evidence suggests it is safe for long-term use, with no major health issues reported in HIV-negative individuals who used it for up to five years. Some people might experience minor side effects, but overall, both forms of PrEP are considered safe for preventing HIV in individuals at risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to deliver information about HIV prevention using PrEP (pre-exposure prophylaxis). Traditional methods often involve direct education about oral or injectable PrEP. However, this trial uses a mock Google search results page to simulate real-world decision-making and test different messaging strategies, such as response efficacy, social norms, and celebrity endorsements. This approach aims to uncover which types of messaging are most effective in encouraging people to consider PrEP, potentially leading to more personalized and impactful communication strategies in the future.

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

Research has shown that injectable PrEP, specifically cabotegravir, is highly effective in preventing HIV, with real-world studies demonstrating over 99% effectiveness. It reduces the risk of HIV by 79% across various groups and situations. Participants in this trial will receive information about injectable PrEP through a mock Google search results page.

For oral PrEP, studies indicate it reduces the risk of contracting HIV from sex by 99% when taken correctly. In areas where Truvada, a common oral PrEP, is widely used, significant drops in new HIV cases have occurred. Participants in this trial will also receive information about oral PrEP through a similar mock Google search results page. These findings support the use of both injectable and oral PrEP as highly effective methods for preventing HIV. ^{6 7 8 9 10}

Who Is on the Research Team?

Christofer J Skurka, PhD

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

This trial is for HIV-negative, gay or bisexual cisgender males aged 18-34 who've had anal sex in the past 6 months. They must either have an HIV-positive partner, inconsistent condom use, or a recent STI diagnosis. Participants need internet access for Study 1.

Inclusion Criteria

Have an Internet-connectable device (Study 1 only)

I am at risk for HIV due to my sexual activity or recent STI.

Identify as gay or bisexual

Exclusion Criteria

Does not meet all of the criteria above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Study 1 - Online Experiment

Participants engage in an online browsing task to explore information about oral or injectable PrEP, with browsing behavior logged.

1 session (3 minutes max)

Online participation

Study 2 - In-person Experiment

Participants complete an in-person browsing task with eye-tracking to explore information about injectable PrEP, with browsing and visual behavior logged.

1 session (3 minutes max)

1 visit (in-person)

Follow-up

Participants are monitored for changes in intention to adopt PrEP and provide feedback on messaging strategies.

Immediately after browsing task

What Are the Treatments Tested in This Trial?

Interventions

• Injectable PrEP information
• Oral PrEP information

Trial Overview

The study tests how young men respond to online information about oral and injectable PrEP (a medication regimen that helps prevent HIV). It tracks which messages are most engaging by monitoring browsing and visual behavior with eye-trackers in Study 2.

How Is the Trial Designed?

Group I: Oral PrEP information (Study 1 only) Experimental Treatment 1 Intervention

A mock Google search results page with five search results that reflect five messaging strategies about oral PrEP (response efficacy, social norms, exemplar, celebrity, and basic information), displayed in random order.

Group II: Injectable PrEP information Experimental Treatment 1 Intervention

A mock Google search results page with five search results that reflect five messaging strategies about injectable PrEP (response efficacy, social norms, exemplar, celebrity, and basic information), displayed in random order.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

Published Research Related to This Trial

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]

Cabotegravir (Apretude) is an effective extended-release injectable medication used as pre-exposure prophylaxis (PrEP) to significantly reduce the risk of acquiring HIV-1 in HIV-negative individuals at risk.

It is approved for use in adults and adolescents who weigh at least 35 kg (77 lb), highlighting its targeted application for those most vulnerable to sexually transmitted HIV-1.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir (Apretude) for Pre-exposure Prophylaxis for HIV Type 1 Infection. El-Haddad, A., Erlich, D.[2023]

Cabotegravir-based PrEP has shown higher effectiveness than oral tenofovir-based PrEP, with a significant reduction in HIV incidence among men who have sex with men (MSM) and transgender women (hazard ratio of 0.31) and among cisgender women in sub-Saharan Africa (hazard ratio of 0.11).

While cabotegravir is highly effective, challenges such as the need for HIV RNA monitoring, additional clinic resources, and the provision of oral medication during dosing interruptions must be addressed for successful implementation in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promises and challenges: cabotegravir for preexposure prophylaxis. Spinelli, MA., Grinsztejn, B., Landovitz, RJ.[2023]

Cabotegravir long-acting, an injectable form of PrEP, has shown high efficacy in preventing HIV-1 transmission in macaque models, suggesting it could be a powerful alternative to daily oral PrEP like Truvada.

With a potential dosing schedule of once every three months, cabotegravir long-acting may significantly improve adherence to HIV prevention strategies, addressing a key limitation of daily regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir long-acting for HIV-1 prevention. Andrews, CD., Heneine, W.[2020]

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 a phase 3 study involving 5387 participants, daily emtricitabine and tenofovir alafenamide was found to be non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, with a lower incidence of HIV infections in the tenofovir alafenamide group (0.16 vs 0.34 infections per 100 person-years).

The tenofovir alafenamide regimen demonstrated better safety profiles, showing superior outcomes in bone mineral density and renal biomarkers compared to the tenofovir disoproxil fumarate regimen, with low rates of adverse events leading to discontinuation in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Mayer, KH., Molina, JM., Thompson, MA., et al.[2022]

In the first unblinded year of the HPTN 083 study, long-acting injectable cabotegravir demonstrated high efficacy for HIV prevention, with an incidence rate of 0.82 per 100 person-years compared to 2.27 per 100 person-years for daily oral tenofovir disoproxil fumarate plus emtricitabine, resulting in a hazard ratio of 0.35, indicating a significant reduction in HIV risk.

Despite the high efficacy, there were concerns about diagnostic delays and the emergence of integrase strand-transfer inhibitor (INSTI) resistance in some cases of HIV infection among those receiving cabotegravir, highlighting the need for careful monitoring and further investigation into potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of long-acting cabotegravir compared with daily oral tenofovir disoproxil fumarate plus emtricitabine to prevent HIV infection in cisgender men and transgender women who have sex with men 1 year after study unblinding: a secondary analysis of the phase 2b and 3 HPTN 083 randomised controlled trial. Landovitz, RJ., Hanscom, BS., Clement, ME., et al.[2023]

In a study involving 540 pregnant women, the use of tenofovir disoproxil fumarate and emtricitabine as pre-exposure prophylaxis (PrEP) was found to be non-inferior to deferred PrEP in terms of preterm birth and small for gestational age outcomes, suggesting it is a safe option during pregnancy.

The immediate initiation of PrEP did not increase the risk of adverse pregnancy outcomes such as low birthweight or stillbirth, providing reassurance for its use among pregnant women not living with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy and neonatal safety outcomes of timing of initiation of daily oral tenofovir disoproxil fumarate and emtricitabine pre-exposure prophylaxis for HIV prevention (CAP016): an open-label, randomised, non-inferiority trial. Moodley, D., Lombard, C., Govender, V., et al.[2023]

Tenofovir alafenamide-emtricitabine (F/TAF) is a safer option for HIV preexposure prophylaxis (PrEP) compared to tenofovir disoproxil fumarate-emtricitabine (F/TDF), with F/TAF potentially averting 2101 fractures and 25 cases of end-stage renal disease (ESRD) over five years for 123,610 men who have sex with men (MSM) using PrEP.

The maximum price that payers should be willing to pay for F/TAF over generic F/TDF is estimated at $8670 per year, reflecting its improved safety profile, which is valued at no more than an additional $370 per person per year when considering the cost-effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis. Walensky, RP., Horn, T., McCann, NC., et al.[2021]

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