PrEP Counseling for HIV Prevention

Overseen By Jaimie P Meyer, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: PrEP

Disqualifiers: Hysterectomy, Tubal ligation, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to integrate HIV prevention into counseling visits at sexual and reproductive health clinics. It tests an interactive tool called the PrEP Decision Aid, which helps women understand their HIV risk and options before seeing their clinician. Participants will either use this tool or watch a CDC video about PrEP, a medication that helps prevent HIV. Women who are 18 or older, have a uterus, do not have HIV, and are not currently on PrEP might be a good fit. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in HIV prevention.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the PrEP Decision Aid is safe for use in counseling visits?

Research shows that the PrEP Decision Aid helps people make informed choices about preventing HIV. This tool supports decision-making for using PrEP (pre-exposure prophylaxis), a medication that significantly reduces the risk of contracting HIV.

Studies have found that PrEP is safe and effective when taken as directed. It can lower the risk of acquiring HIV from sex by about 99% and from injection drug use by at least 74%. The decision aid assists individuals in evaluating their own risk and understanding PrEP better before discussing it with a doctor.

No evidence suggests that using the decision aid itself causes harm. Instead, it provides clear information to help people make safer health choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The PrEP Decision Aid is unique because it empowers individuals to independently evaluate their HIV risk and gain awareness about PrEP (Pre-Exposure Prophylaxis) before meeting with their healthcare provider. Unlike standard educational options, such as generic informational videos or pamphlets, this interactive tool is personalized and patient-focused, enhancing informed decision-making. Researchers are excited about this approach because it could lead to more proactive and informed discussions between patients and clinicians, potentially improving engagement and adherence to PrEP regimens.

What evidence suggests that the PrEP Decision Aid is effective for HIV prevention?

Research has shown that PrEP (pre-exposure prophylaxis) is highly effective at preventing HIV, with studies finding that consistent use can lower the risk of contracting HIV by up to 93%. In this trial, participants may be randomized to use the PrEP Decision Aid, a tool designed to help individuals determine if PrEP suits their needs by clarifying their HIV risk. While this decision aid is still under evaluation, PrEP's ability to prevent HIV is well-proven. ^{1 2 6 7 8}

Who Is on the Research Team?

Jaimie P Meyer, MD

Principal Investigator

Yale Clinical and Community Research, Yale School of Medicine

Sangini S Sheth, MD

Principal Investigator

Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking cis-women aged 18+ with a uterus, who are not HIV positive, not on PrEP, and seeking contraceptive counseling at participating clinics. It's also for clinic staff involved in patient care. Those planning pregnancy or have had certain surgeries won't qualify.

Inclusion Criteria

I do not have HIV.

Sexual and Reproductive Health (SRH) clinicians providing SRH patient care at participating sites

Able to participate in informed consent procedures

Exclusion Criteria

Have a scheduled visit with a member of the investigative team

Participants of Aim 1 cannot participate in Aim 2.

I cannot become pregnant due to surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to receive either the PrEP decision aid or generic PrEP information prior to a clinician visit

6 months

Initial visit followed by follow-up interviews at Months 3 and 6

Follow-up

Participants are monitored for PrEP initiation, feasibility, acceptability, adoption, and penetration of the decision aid

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PrEP Decision Aid

Trial Overview

The study is testing whether integrating an HIV prevention tool called 'PrEP Decision Aid' into family planning clinics' contraceptive counseling can help prevent HIV. Participants will receive either this decision aid or generic information to compare effectiveness.

How Is the Trial Designed?

Group I: PrEP Decision Aid Experimental Treatment 1 Intervention

Participants randomized to the decision aid (active intervention arm), will interact with the enhanced PrEP decision aid in REDCap. This is an individualized, patient-facing decision aid that supports informed patient choice and is interactive. In contrast to shared decision aids that guide a clinical encounter, the participants uses the individualized decision aid prior to the clinical encounter to discretely assess HIV risk and build awareness before discussing with their clinician

Group II: Generic Information Experimental Treatment 1 Intervention

Participants randomized to this arm will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis)" (available online free of charge through CDC website) that will serve as a time- and attention-based control.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A study involving 29 Black patients (4 women and 25 men) revealed that many experienced decision conflict regarding the adoption of PrEP due to insufficient information, concerns about side effects, and inadequate time during consultations with healthcare providers.

Participants expressed a need for more detailed information about PrEP and support in aligning their personal values with the treatment's benefits and risks, highlighting the importance of decision support in improving PrEP uptake among eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision conflict and the decision support needs of HIV PrEP-eligible Black patients in Toronto regarding the adoption of PrEP for HIV prevention. Ajiboye, W., Nelson, L., Odhiambo, A., et al.[2023]

In a systematic review of 59 studies involving 43,917 participants, it was found that 41% of individuals discontinued HIV pre-exposure prophylaxis (PrEP) within 6 months, with the highest rates observed in sub-Saharan Africa (47.5%).

Implementing adherence interventions significantly reduced discontinuation rates (24.7% vs 36.7%), and offering flexible dosing options (daily or non-daily) led to lower discontinuation among gay or bisexual men and transgender women (21.6% vs 31.5%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. Zhang, J., Li, C., Xu, J., et al.[2023]

In a study involving 3065 high-risk HIV-negative adults, the incidence of HIV-1 was very low at 1.1 cases per 1000 person-years, showing that both daily and on-demand PrEP are effective in preventing HIV infection.

There was no significant difference in HIV-1 incidence between those using daily PrEP and those using on-demand PrEP, indicating that on-demand PrEP is a valid alternative, providing flexibility for men who have sex with men (MSM) in their HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Molina, JM., Ghosn, J., Assoumou, L., et al.[2022]

Healthcare providers in Alabama identified several barriers to prescribing PrEP, including insufficient training, time constraints, and concerns about side effects, which contribute to its underuse in a high HIV incidence area.

Implementing clinical decision support (CDS) tools, along with comprehensive training for all clinic staff, could enhance PrEP prescribing practices and address these barriers effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Health Care Professionals' Perspectives to Refine a Clinical Decision Support Implementation Strategy for Increasing the Prescribing of HIV Preexposure Prophylaxis (PrEP) in Alabama. Humphries, DL., Rhodes, EC., Simon, CL., et al.[2023]

Nearly half of the participants (47%) who started pre-exposure prophylaxis (PrEP) for HIV prevention discontinued its use, primarily due to systemic issues such as financial problems and logistical barriers related to clinics and pharmacies.

Behavioral factors and concerns about medication side effects also contributed to discontinuation, highlighting the need for addressing both systemic and personal factors to improve PrEP retention and engagement in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. Unger, ZD., Golub, SA., Borges, C., et al.[2023]

Pre-exposure prophylaxis (PrEP), particularly using Truvada® (tenofovir disoproxil fumarate/emtricitabine), has been shown to effectively reduce the incidence of HIV infection among high-risk individuals, especially when combined with other preventive methods.

While PrEP has a good safety profile, with mild to moderate gastrointestinal side effects being the most common, regular monitoring of liver enzymes, renal function, and bone mineral density is essential to manage potential long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. Tetteh, RA., Yankey, BA., Nartey, ET., et al.[2022]

Citations

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New Study Forecasts Surge in Preventable HIV Infections ...

As of 2022, only 36% of the 1.2 million Americans with indications for PrEP were prescribed it, up from just 13% in 2017. This remains short of ...

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Decision Support Tool to Improve Decision-Making for HIV Pre ...

Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability.

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sciencedirect.com/science/article/pii/S2468266722001062

Real-world effectiveness of pre-exposure prophylaxis in ...

We found that PrEP use was associated with an overall 60% reduction in the risk of HIV infection, reaching 93% for a high amount of PrEP consumption, and 86% if ...

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hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis

Pre-Exposure Prophylaxis

PrEP reduces the risk of getting HIV from sex by about 99% when taken as prescribed. Among people who inject drugs, it reduces the risk by at least 74% when ...

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PrEP to Prevent HIV and Promote Sexual Health

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Informed decision making in the context of HIV prevention

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