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

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the PrEP Decision Aid treatment for HIV prevention?

Research shows that shared decision-making tools, which help people choose the best HIV prevention method for them, can increase the use of PrEP (a medication to prevent HIV). These tools consider personal preferences and can lead to more people starting and sticking with PrEP, especially when they understand its benefits and have support from healthcare providers. ^{1 2 3 4 5}

Is PrEP safe for humans?

PrEP, used for HIV prevention, generally has a good safety profile based on clinical trials. Some mild to moderate side effects like nausea, vomiting, and diarrhea have been observed, and regular monitoring is recommended to prevent long-term issues with liver, kidneys, and bones. ^{6 7 8 9 10}

How is the PrEP Decision Aid treatment different from other HIV prevention treatments?

The PrEP Decision Aid is unique because it focuses on shared decision-making, helping individuals choose the best HIV prevention strategy for them by considering their personal preferences and values, unlike traditional methods that may not address individual decision conflicts or provide personalized support. ^{3 5 11 12 13}

What is the purpose of this trial?

This study addresses the need for HIV prevention to be integrated into contraceptive counseling visits at family planning clinics.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

From declining PrEP to PrEP initiation as "first nature" - what changes PrEP initiation decisions among young, Black MSM. [2023]

2. United States 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. [2023]

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

Salient Constructs for the Development of Shared Decision-Making Tools for HIV Pre-Exposure Prophylaxis Uptake and Regimen Choice: Behaviors, Behavioral Skills, and Beliefs. [2022]

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

Preferences for Long-Acting and Alternative Modalities for PrEP among Military Men Who Have Sex with Men: Segmentation Results of an Adaptive Choice-Based Conjoint Analysis Study. [2022]

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

Evaluating Patient Perceptions on PrEP Screening and Referral in the Acute Care Setting. [2023]

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

Reasons for PrEP Discontinuation After Navigation at Sexual Health Clinics: Interactions Among Systemic Barriers, Behavioral Relevance, and Medication Concerns. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns. [2022]

8. Netherlands 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. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. [2023]

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

Evolving Models and Ongoing Challenges for HIV Preexposure Prophylaxis Implementation in the United States. [2020]

11. United States 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. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Understanding pre-exposure prophylaxis (PrEP) regimen use: Switching and discontinuing daily and event-driven PrEP among men who have sex with men. [2022]

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

Changes in self-reported risky sexual behaviour indicators among adults receiving regular risk reduction counselling and optional initiation of pre-exposure prophylaxis in an HIV vaccine preparedness study in Masaka, Uganda. [2023]