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Integrating PrEP Decision Making Into Contraceptive Counseling in Family Planning Clinics

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Yale University

Status

Not yet enrolling

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 contraceptive counseling visits at family planning 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 (SRH) settings during contraceptive counseling visits, where PrEP can be provided to all women who are interested. Rooted in the Health Equity Implementation Framework, this study evaluates health equity 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 SRH 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 SRH clinics. Qualitative interviews will inform infrastructure development to support PrEP delivery in SRH 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):

  • Cis-women
  • 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 contraceptive 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 (SRH) clinicians will be included if they provide SRH patient care at any of the participating sites. SRH 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

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

Trial contacts and locations

1

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Central trial contact

Carolina Price, MPA; Jaimie P Meyer, MD

Data sourced from clinicaltrials.gov

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