Pre-Exposure Prophylaxis for HIV Prevention

Overseen By Erica J Hardy, MD, MMSc, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Seeking abortion care

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how patients and doctors perceive the use of pre-exposure prophylaxis (PrEP) to prevent HIV in a family planning clinic. It aims to determine if patients are open to discussing and starting PrEP during their visits and what factors might facilitate or hinder these conversations. Patients visiting the Women and Infants Hospital of Rhode Island Family Planning Clinic who speak English or Spanish and are not seeking abortion care may be suitable candidates. Participants will receive counseling or training about PrEP and share their experiences through surveys. As an unphased trial, this study offers participants the chance to contribute to significant research that could enhance HIV prevention strategies in family planning settings.

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. It seems focused on adding PrEP to your routine care, so you may not need to stop other medications.

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving the methods for preventing HIV through pre-exposure prophylaxis (PrEP). Unlike traditional treatments that mainly center on prescribing medication to at-risk individuals, this trial emphasizes screening patients and training physicians, aiming to enhance the effectiveness and accessibility of PrEP. By prioritizing comprehensive patient screening and equipping healthcare providers with specialized training, the trial seeks to optimize PrEP delivery and ensure that it reaches those who need it most. This approach could lead to better prevention strategies and a significant reduction in HIV transmission rates.

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

Research shows that pre-exposure prophylaxis (PrEP) is effective in preventing HIV infection, with studies indicating that it can be successfully implemented in real-world settings. Training programs for physicians have improved their knowledge and comfort in prescribing PrEP, which is crucial for increasing its uptake and effectiveness. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for patients and physicians at the Women and Infants Hospital of Rhode Island Family Planning Clinic. Patients will discuss HIV prevention medications (PrEP) during their visit, may start PrEP, and complete a survey. Physicians will learn about PrEP, support patients starting it, and provide feedback through surveys.

Inclusion Criteria

Provide care at the Women and Infants Hospital of Rhode Island Family Planning Clinic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Education and Counseling

Patient participants receive standardized counseling about PrEP, and physician participants receive standardized education about PrEP.

1-2 weeks

1 visit (in-person)

PrEP Initiation and Routine Care

Participants have the opportunity to begin PrEP as part of their routine, ongoing care.

Ongoing

Integrated into routine visits

Follow-up

Participants are monitored for feasibility and acceptability of PrEP initiation and use.

Up to 1 year

Post-visit questionnaires and interviews

What Are the Treatments Tested in This Trial?

Interventions

• Patient participant screening
• Physician participant training

Trial Overview The study aims to evaluate the acceptance of discussing and offering HIV prevention drugs (PrEP) in a family planning clinic setting. It assesses factors that facilitate or hinder talking about and initiating PrEP among both patients receiving care and physicians providing counseling.

How Is the Trial Designed?

Group I: Physician Participant Experimental Treatment 1 Intervention

Group II: Patient Participant Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Advance RI CTR

Collaborator

Published Research Related to This Trial

A qualitative study involving 18 U.S.-based PrEP providers revealed that most had positive experiences with prescribing PrEP, indicating that common barriers like financial coverage and side effects were generally manageable.

Providers noted that patient adherence to PrEP was better among those who actively sought it out, and they emphasized the need for improved training for inexperienced providers, particularly in areas like sexual history-taking and understanding sexual minority issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting PrEP into Practice: Lessons Learned from Early-Adopting U.S. Providers' Firsthand Experiences Providing HIV Pre-Exposure Prophylaxis and Associated Care. Calabrese, SK., Magnus, M., Mayer, KH., et al.[2022]

Citations

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

A Multicomponent Approach to Evaluating a Pre-exposure Prophylaxis (PrEP) Implementation Program in Five Agencies in New York. [2019]

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

Putting PrEP into Practice: Lessons Learned from Early-Adopting U.S. Providers' Firsthand Experiences Providing HIV Pre-Exposure Prophylaxis and Associated Care. [2022]

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

Recommendations for Increasing Physician Provision of Pre-Exposure Prophylaxis: Implications for Medical Student Training. [2022]

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

Integrating HIV Pre-Exposure Prophylaxis (PrEP) Education During Medical Residency: Training Outcomes and Suggestions for Learning Effectiveness. [2023]

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

Preparing for PrEP: perceptions and readiness of canadian physicians for the implementation of HIV pre-exposure prophylaxis. [2023]