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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand preferences and attitudes about HIV prevention options among cisgender women and trans individuals. It focuses on those either taking a daily anti-HIV pill (PrEP) or at risk of contracting HIV but not currently taking the medication. Participants will complete questionnaires to help researchers learn how to best support HIV prevention. Suitable candidates include cisgender women and trans individuals who have thought about taking PrEP, decided to take it, considered but decided against it, or stopped using it. As an unphased trial, this study offers participants the chance to contribute to important research that could shape future HIV prevention strategies.

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 prior data suggests that this individualized feedback is safe for HIV prevention?

Research shows that personalized advice can help people make better health choices. For instance, one study found that when people received specific feedback about their risk of heart disease, they understood their risk better and became more active.

Although these studies examine different health issues, they suggest that participants generally find personalized advice safe and welcoming. No reports of negative effects from this kind of feedback have emerged. Therefore, joining a trial offering personalized advice appears to be a safe approach that could aid in making better health decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the individualized feedback method for HIV prevention because it tailors advice and support based on personal circumstances, which is a departure from the one-size-fits-all approach of standard methods like PrEP (pre-exposure prophylaxis). This personalized approach considers the unique needs and experiences of cisgender women and transgender individuals, offering feedback whether they are currently taking PrEP, have chosen not to, or have stopped. By focusing on individual decision-making and behavior, this method aims to better support people in managing their HIV risk, potentially leading to more effective prevention strategies.

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

Research has shown that personalized feedback can help people adopt healthier habits. One study found that tailored feedback improved heart health and increased physical activity in people with HIV. Other studies suggest that personal interventions can reduce risky behaviors linked to HIV. In this trial, participants will receive individualized feedback to help them understand their risk of infection and take action. This approach might also encourage participants to consistently take PrEP, a daily pill that helps prevent HIV, supporting overall prevention efforts. ^{4 5 6 7 8}

Who Is on the Research Team?

Magdalena Sobieszczyk, MD, MPH

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

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]

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]

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]

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 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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8300575/

Results of a pilot randomized clinical trial - PMC Personalized Feedback Improves Cardiovascular Risk Perception and Physical Activity Levels in Persons With HIV: Results of a pilot randomized clinical trial.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5373976/

Quality of HIV Testing Data Before and After the ... Completeness also improved with feedback implementation but remained low for linkage to HIV care (56.0% vs 64.0%), referral to partner services (58.9% vs 62.8%) ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749379706005551

The Effectiveness of Individual-, Group ... The evidence found in our review shows that individual-level, group-level, and community-level HIV behavioral interventions are effective in reducing the odds ...

4. journals.lww.com journals.lww.com/aidsonline/fulltext/2021/03150/interactive_digital_interventions_for_prevention.13.aspx

Interactive digital interventions for prevention of... : AIDS This systematic review assesses the effectiveness of interactive digital interventions (IDIs) for prevention of sexually transmitted HIV.

5. link.springer.com link.springer.com/article/10.1007/s10461-025-04745-4

A Systematic Review of the Effectiveness of HIV Prevention ... We conducted a systematic review of HIV prevention interventions implemented in LMICs, published between 2010 and 2022, that used pre/post or multi-arm methods.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8971984/

Individualized Provider Feedback Increased HIV and HCV ... Overall, 41.80% of patients had documented HIV testing and 33.46% had documented HCV testing since 2012 in the pre-intervention period. This increased to 44.04% ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/08870446.2025.2519115

Informed decision making in the context of HIV prevention Our findings suggest that informed HIV prevention decisions are associated with higher perceived safety and act compensatory towards low personal safety ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03935945

Brief Personalized Feedback Intervention for Hazardous ... Outcomes include drinking change processes and behavior, alcohol-related risky sexual behavior, and HIV-related outcomes. An underlying premise, which will ...