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

675 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of these two intervention studies is to test promising health communication messaging strategies most likely to enhance Black, Hispanic, and non-Hispanic White YMSM's (young men who have sex with men's) engagement with online content about injectable and oral PrEP (pre-exposure prophylaxis). Participants will be asked to browse a mock Google results page featuring various kinds of PrEP information, and their browsing behavior will be unobtrusively logged. In Study 1, participants will be randomly assigned to browse for information about oral PrEP or browse for information about injectable PrEP. The design of Study 2 will be identical to Study 1 but will focus only on injectable PrEP content. In addition to browsing behavior, visual behavior data will also be collected in Study 2 with eye-trackers.

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 data supports the effectiveness of the drug Cabotegravir for HIV prevention?

Research shows that injectable Cabotegravir is more effective than daily oral tenofovir disoproxil fumarate plus emtricitabine in preventing HIV infection, especially for those who struggle with taking daily medication. ^{1 2 3 4 5}

Is PrEP safe for humans?

Injectable cabotegravir (Apretude) and oral PrEP options like tenofovir disoproxil fumarate with emtricitabine have been studied for safety. Cabotegravir is generally safe but may cause diagnostic delays and resistance issues, while tenofovir alafenamide shows improved kidney and bone safety compared to tenofovir disoproxil fumarate. ^{1 3 6 7 8}

How does the drug cabotegravir differ from other HIV prevention drugs?

Cabotegravir is unique because it is a long-acting injectable drug, which means it is given as a shot and lasts for a longer time, unlike other HIV prevention drugs that need to be taken daily as pills. This can be especially helpful for people who find it hard to remember to take a pill every day. ^{1 2 3 9 10}

Research Team

Christofer J Skurka, PhD

Principal Investigator

Penn State University

Eligibility Criteria

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)

Identify as gay or bisexual

Be HIV negative

Exclusion Criteria

Does not meet all of the criteria above

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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 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 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]

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]

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]

References

1. Netherlands 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. [2023]

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

Promises and challenges: cabotegravir for preexposure prophylaxis. [2023]

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

Cabotegravir (Apretude) for Pre-exposure Prophylaxis for HIV Type 1 Infection. [2023]

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

Cabotegravir long-acting for HIV-1 prevention. [2020]

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

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

6. England 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. [2022]

7. Netherlands 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. [2023]

8. United States 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. [2021]

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

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

10. 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]