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

83 Participants Needed

Trial Summary

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.

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}

How is the treatment for HIV prevention in this trial different from other treatments?

This treatment focuses on pre-exposure prophylaxis (PrEP), which is a preventive approach for people at high risk of HIV, involving taking medication before potential exposure to the virus. Unlike other treatments that manage HIV after infection, PrEP aims to prevent the virus from establishing an infection in the first place, and it requires consistent adherence and clinical monitoring. ^{2 3 6 7 8}

What is the purpose of this trial?

The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic. These medications are known as pre-exposure prophylaxis, or PrEP. The main questions to answer are: 1. Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic? 2. What things make it easier or harder to ask about PrEP in a family planning clinic setting? 3. What things make it easier or harder to begin PrEP in a family planning clinic setting? Patient participants: 1. Will receive standardized counseling about PrEP. 2. Will have the opportunity to begin PrEP as part of their routine, ongoing care. 3. Will be asked to complete a survey about their experiences. Physician participants: 1. Will receive standardized education about PrEP. 2. Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP. 3. Will be asked to complete pre-and post-study surveys about their experiences. 4. May be asked to complete a post-study in-depth interview about their experiences.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

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]

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

Engaging healthcare providers to implement HIV pre-exposure prophylaxis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Improving Pre-exposure Prophylaxis Counseling at a Military Women's Health Care Clinic to Champion CDC and Defense Health Agency Recommendations. [2023]

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

A Cross-sectional Survey of Internal Medicine Resident Knowledge, Attitudes, Behaviors, and Experiences Regarding Pre-Exposure Prophylaxis for HIV Infection. [2020]