Individualized Feedback for HIV Prevention

(S2P:CWTI Trial)

Overseen By Deborah Theodore, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Living with HIV

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

175 Participants Needed

Trial Summary

What is the purpose of this trial?

Taking a daily anti-HIV pill can protect people from HIV infection. This is called preexposure prophylaxis \[PrEP\]. Many cisgender women and trans individuals do not know this medication is available; others struggle to take the pill every day. It is important to understand attitudes and preferences about HIV prevention options, especially as new options become available. This study plans to evaluate preferences over time among cisgender women and trans individuals who are taking medication to prevent HIV, and among cisgender women and trans individuals who are not taking medication but are at risk of HIV. The investigators enroll up to 175 participants who visit the HIV prevention clinic, and the investigators will ask participants to complete questionnaires at regular follow up visits and between visits. This study may help the investigators understand how best to prevent HIV among people at risk.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on understanding preferences for HIV prevention options, so it's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Truvada for HIV prevention?

Research shows that Truvada, a combination of emtricitabine and tenofovir disoproxil fumarate, is effective in preventing HIV infection, even against certain resistant strains, as demonstrated in a study with macaques. Additionally, it has been approved as a preexposure prophylaxis (PrEP) therapy for adults at high risk for sexually acquired HIV infection. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Truvada, a combination of emtricitabine and tenofovir disoproxil fumarate, is used for HIV prevention and is considered safe for adults, with no short-term irritating toxicity reported. ^{1 2 3 6 7}

How does the drug for individualized feedback for HIV prevention differ from other HIV prevention drugs?

The drug used in individualized feedback for HIV prevention is unique because it involves pre-exposure prophylaxis (PrEP) with Truvada, which combines emtricitabine and tenofovir disoproxil fumarate. This combination is effective in preventing HIV in high-risk individuals and is known for its favorable dosing schedule, minimal interactions, and excellent safety record. ^{3 6 8 9 10}

Research Team

Magdalena Sobieszczyk, MD, MPH

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for cisgender women and trans individuals who are considering HIV prevention options. Participants may be those who have chosen to take, not to take, or stop taking pre-exposure prophylaxis (PrEP). They must be able to give informed consent and cannot participate if they are already living with HIV.

Inclusion Criteria

Cisgender women and trans individuals who have an indication for PrEP and have 1) decided to take PrEP, 2) decided not to take PrEP, or 3) decided to discontinue PrEP

Exclusion Criteria

Living with HIV

Cannot provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PrEP and complete online questionnaires about demographic characteristics, social determinants of health, and preferences regarding PrEP modalities

12 months

Regular follow-up visits and online questionnaires

Follow-up

Participants are monitored for retention in care and adherence to PrEP through electronic medical records and self-reported adherence

12 months

Treatment Details

Interventions

• Individualized Feedback

Trial Overview The study evaluates attitudes and preferences towards HIV prevention methods among participants at risk of HIV. It involves completing questionnaires during clinic visits and between visits over time, aiming to improve understanding of PrEP use in these populations.

Participant Groups

Group I: Cisgender Women and Trans Individuals (CWTI) Experimental Treatment 1 Intervention

Cisgender women and trans individuals (CWTI) who are taking PrEP, have considered and decided not to take PrEP, or who have discontinued PrEP.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Truvada, a once-daily combination pill containing tenofovir disoproxil fumarate and emtricitabine, is expected to be an effective and low-toxicity treatment option for managing HIV, especially in developing countries.

While there is limited clinical efficacy data available, existing studies suggest that emtricitabine is as potent as lamivudine, and trials have shown that tenofovir combined with lamivudine is effective when paired with other antiretroviral medications for up to 96 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of tenofovir disoproxil fumarate and emtricitabine combination in HIV-infected patients. Gazzard, BG.[2019]

In a study using macaques, daily preexposure prophylaxis (PrEP) with Truvada was shown to effectively protect against an HIV mutant resistant to FTC, with all treated animals remaining uninfected after exposure, while all untreated controls became infected.

The protection observed may be due to increased susceptibility of the virus to tenofovir, residual antiviral effects of FTC, and reduced virus fitness from the M184V mutation, indicating that Truvada can still be effective even against resistant strains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection against rectal transmission of an emtricitabine-resistant simian/human immunodeficiency virus SHIV162p3M184V mutant by intermittent prophylaxis with Truvada. Cong, ME., Youngpairoj, AS., Zheng, Q., et al.[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]

In a study involving 591 participants (186 women and 405 men) evaluating the impact of different PrEP regimens on health-related quality of life (QOL), it was found that starting a candidate PrEP regimen did not significantly change QOL over 48 weeks, indicating that these regimens are safe in terms of maintaining quality of life.

Mean QOL scores remained stable and comparable to the general population, with no significant differences observed between different PrEP regimens or between participants who continued versus those who discontinued the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No change in health-related quality of life for at-risk U.S. women and men starting HIV pre-exposure prophylaxis (PrEP): Findings from HPTN 069/ACTG A5305. Kapadia, SN., Wu, C., Mayer, KH., et al.[2023]

In a phase 3 trial with 663 HIV-infected adults, switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) showed similar effectiveness in maintaining viral suppression, with 88.6% of TAF users and 89.1% of TDF users achieving HIV-1 RNA levels below 50 copies per milliliter after 96 weeks.

Patients switching to TAF experienced improvements in kidney function and bone mineral density compared to those remaining on TDF, indicating that TAF may offer a safer profile with better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Long-Term (96-Week) Efficacy and Safety After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in HIV-Infected, Virologically Suppressed Adults. Raffi, F., Orkin, C., Clarke, A., et al.[2022]

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]

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]

Topical tenofovir gel and daily oral tenofovir/emtricitabine (FTC/TDF) have shown significant efficacy in preventing HIV-1, with reductions in acquisition rates of 39% and 44% respectively in various studies involving different populations.

While tenofovir gel was effective in African women and oral FTC/TDF showed efficacy in men who have sex with men (MSM) and serodiscordant couples, some studies in African women found no efficacy, prompting further investigation into the reasons behind these differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tenofovir-based pre-exposure prophylaxis for HIV prevention: evolving evidence. Celum, C., Baeten, JM.[2021]

Tenofovir disoproxil fumarate (TDF) and emtricitabine are effective antiretroviral medications for pre-exposure prophylaxis (PrEP) against HIV, showing a strong safety record and favorable pharmacokinetics that allow for less frequent dosing.

Understanding how factors like race, gender, and cellular conditions affect drug response is crucial for optimizing PrEP strategies and ensuring effective HIV prevention in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection. Anderson, PL., Kiser, JJ., Gardner, EM., et al.[2022]

In a study involving 1733 antiretroviral-naive adults over 144 weeks, tenofovir alafenamide (TAF) demonstrated superior virologic efficacy compared to tenofovir disoproxil fumarate (TDF), with 84.2% of TAF patients achieving undetectable HIV-1 RNA levels compared to 80.0% for TDF.

TAF showed a better safety profile, causing less impact on bone mineral density and renal function, with no renal-related discontinuations compared to 12 in the TDF group, highlighting TAF's advantages for initial HIV therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. Arribas, JR., Thompson, M., Sax, PE., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Use of tenofovir disoproxil fumarate and emtricitabine combination in HIV-infected patients. [2019]

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

Protection against rectal transmission of an emtricitabine-resistant simian/human immunodeficiency virus SHIV162p3M184V mutant by intermittent prophylaxis with Truvada. [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

No change in health-related quality of life for at-risk U.S. women and men starting HIV pre-exposure prophylaxis (PrEP): Findings from HPTN 069/ACTG A5305. [2023]

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

Brief Report: Long-Term (96-Week) Efficacy and Safety After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in HIV-Infected, Virologically Suppressed Adults. [2022]

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

PrEParing for Preexposure Prophylaxis. [2021]

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

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

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

Tenofovir-based pre-exposure prophylaxis for HIV prevention: evolving evidence. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Pharmacological considerations for tenofovir and emtricitabine to prevent HIV infection. [2022]

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

Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. [2022]