This study addresses the need for HIV prevention to be integrated into counseling visits at sexual and reproductive health clinics.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
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.
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.
Yale Clinical and Community Research
New Haven, Connecticut, United States
RECRUITINGPrEP initiation (prescribing)
Whether PrEP was prescribed (yes/no) in the EHR within the 6-month time frame
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).
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
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Time frame: 6 months
PrEP initiation (dispensing)
Whether PrEP was dispensed (yes/no) in the EHR within the 6-month time frame
Time frame: 6 months
PrEP initiation (first use)
Whether PrEP was started by the patient within the 6 months' time frame (yes/no)
Time frame: 6 months
PrEP adherence
Non-pharmacokinetic: (subjective) 3-item self-report with 30-day look-back
Time frame: 6 months
PrEP adherence
Non-pharmacokinetic: (objective) pharmacy refill data or injection dates for LAI.
Time frame: 6 months
PrEP adherence
Pharmacokinetic: (objective) urine tenofovir levels (units detected/ not detected)
Time frame: 6 months
PrEP persistence
Dates of completed PrEP encounters in EHR (i.e., clinic dates)
Time frame: 6 months