Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

Project Carmenta: Integrating PrEP Decision Making Into Counseling in Sexual and Reproductive Health Clinics

This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.

Study Overview

• Status: Recruiting
• Conditions: Reproductive Health; Sexual Risk Behavior for HIV-infection
• Intervention / Treatment: Other: Generic Information; Device: PrEP Decision Aid

Detailed Description

The purpose of this study is to expand and enhance a PrEP decision aid to include the full array of available formulation options and then integrate its delivery into sexual and reproductive health settings during counseling visits, where PrEP can be provided to all women who are interested. Rooted in health implementation frameworks, this study evaluates health and implementation determinants simultaneously along: 1) innovation characteristics; 2) clinical encounter; 3) recipients; and 4) context.

In Aim 1, patients (n=15-20), clinicians (n=10), and staff (n=10) at sexual and reproductive health clinics across Greater New Haven, CT will be engaged for semi-structured interviews to expand and enhance an existing PrEP decision aid to include all available formulations and optimize its integration into sexual and reproductive health clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in sexual and reproductive health clinics.

In Aim 2 (a hybrid Type 2 effectiveness-implementation study), patients will be randomized (n=50) to receive either the PrEP decision aid or generic PrEP information prior to a clinician visit. In follow-up interviews immediately post-visit, and at Months 3 and 6, primary outcomes are clinical efficacy (PrEP initiation) and implementation (using Proctor definitions for feasibility, acceptability, penetration, and adoption) that are important for future planned scale-up.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolina Price, MPA; Phone Number: 2034998075; Email: carolina.price@yale.edu
• Study Contact Backup: Name: Jaimie P Meyer, MD; Phone Number: 2037376233; Email: jaimie.meyer@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale Clinical and Community Research
      • Contact: Carolina Price, MPA; Phone Number: 203-499-8075; Email: carolina.price@yale.edu
      • Contact: Jaimie P Meyer, MD; Phone Number: 2037376233; Email: jaimie.meyer@yale.edu
      • Principal Investigator: Jaimie P Meyer, MD
      • Principal Investigator: Sangini S Sheth, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Patients (inclusion):

• Woman
• Aged 18 years or older
• Have a uterus
• Do not have HIV (by self-report)
• Not currently on PrEP
• Comfortable conversing in English or Spanish
• Able to participate in informed consent procedures

Patients (exclusion):

• People who cannot become pregnant (i.e., have had a hysterectomy or tubal ligation)
• People who wish to become pregnant (will not qualify for pregnancy prevention counseling)
• Have a scheduled visit with a member of the investigative team (to minimize risk of potential ascertainment bias)
• Participants of Aim 1 cannot participate in Aim 2.

Sexual and Reproductive Health clinicians will be included if they provide sexual and reproductive health patient care at any of the participating sites. Clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PrEP Decision Aid; 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	Device: PrEP Decision Aid; Patient-facing decision-aid on PrEP that will be enhanced to include various formulations of available PrEP. Can be integrated into sexual and reproductive health clinics as part of counseling.
Other: Generic Information; 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.	Other: Generic Information; Participants will be asked to watch a CDC-produced video, "PrEP (Pre-Exposure Prophylaxis" (available online free of charge through the CDC web site). The video will serve as a time- and attention- based control to the decision aid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP initiation (prescribing)	Whether PrEP was prescribed (yes/no) in the EHR within the 6-month time frame	6 months
Feasibility of implementing the enhanced PrEP decision aid in SRH settings, according to the Proctor taxonomy	Feasibility is defined as the extent to which the enhanced PrEP decision aid can be successfully used in SRH clinic settings (qualitative).	6 months
Acceptability of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)	Acceptability is defined as the user perception that the enhanced PrEP decision aid is acceptable in SRH settings.	6 months
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)	Penetration (reach) of the intervention, measured by recruitment rate (number of participants enrolled per month)	6 months
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)	Penetration (reach) of the intervention, measured by completion rate (percentage of participants completing 6-month interviews out of those enrolled)	6 months
Penetration (reach) of the enhanced decision aid within SRH clinics (Proctor taxonomy)	Penetration (reach) of the intervention, measured by reasons for not meeting inclusion criteria	6 months
Adoption of the enhanced PrEP decision aid within SRH settings, according to users (Proctor taxonomy)	Adoption of the enhanced decision aid into SRH clinics, assessed by whether PrEP was discussed during the visit (yes/no)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PrEP initiation (dispensing)	Whether PrEP was dispensed (yes/no) in the EHR within the 6-month time frame	6 months
PrEP initiation (first use)	Whether PrEP was started by the patient within the 6 months' time frame (yes/no)	6 months
PrEP adherence	Non-pharmacokinetic: (subjective) 3-item self-report with 30-day look-back	6 months
PrEP adherence	Non-pharmacokinetic: (objective) pharmacy refill data or injection dates for LAI.	6 months
PrEP adherence	Pharmacokinetic: (objective) urine tenofovir levels (units detected/ not detected)	6 months
PrEP persistence	Dates of completed PrEP encounters in EHR (i.e., clinic dates)	6 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jaimie P Meyer, MD, Yale Clinical and Community Research, Yale School of Medicine; Principal Investigator: Sangini S Sheth, MD, Obstetrics, Gynecology & Reproductive Sciences, Yale School of Medicine

Publications and helpful links

Helpful Links

• PrEP (Pre-Exposure Prophylaxis)

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 5, 2027

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PrEP; HIV Prevention; woman; sexual reproductive health
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 2000038555; 1R34MH137756-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No