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

Yale University

Status: Begins enrollment this month

Conditions: Sexual Risk Behavior for HIV-infection; Reproductive Health

Treatments: Device: PrEP Decision Aid; Other: Generic Information

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06684613

1R34MH137756-01 (U.S. NIH Grant/Contract)

2000038555

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 .

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

PrEP Decision Aid

Experimental group

Description:

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

Treatment:

Device: PrEP Decision Aid

Generic Information

Other group

Description:

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.

Treatment:

Other: Generic Information