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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH137756-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PrEP Decision Aid | Experimental | 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 |
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| Generic Information | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP Decision Aid | Device | 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. |
| 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) |
| 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) |
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Patients (inclusion):
Patients (exclusion):
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 .
Woman
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Price, MPA | Contact | 2034998075 | carolina.price@yale.edu | |
| Jaimie P Meyer, MD | Contact | 2037376233 | jaimie.meyer@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Clinical and Community Research | Recruiting | New Haven | Connecticut | 06519 | United States |
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| Label | URL |
|---|---|
| PrEP (Pre-Exposure Prophylaxis) | View source |
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We will use health-focused implementation frameworks to develop a semi-structured interview guide for the formative work in Aim 1. Domains will be measured in Aim 2 to examine implementation determinants. In Aim 2, we will randomize participants 1:1 to receive either a) the enhanced decision aid developed in Aim 1, or b) generic information on PrEP provided by a CDC-produced video, PrEP (Pre-Exposure Prophylaxis).
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| Generic Information | Other | 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. |
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Adoption of the enhanced decision aid into SRH clinics, assessed by whether PrEP was discussed during the visit (yes/no) |
| 6 months |
| 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 |