Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656676
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
WePrEP Developing a PrEP Shared Decision-making Tool for Transgender Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
WePrEP A Bilingual Shared Decision-making Tool to Facilitate Conversations Between Transgender Women and Their Providers as They Select an Ideal PrEP Method
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HIV prevalence among transgender women TW in the United States is high 14 The best way to reduce HIV incidence in this population is to link TW to HIV pre-exposure prophylaxis PrEP which can reduce HIV transmission by up to 86 with optimal adherence The FDA approved the first long-acting form of PrEP injectable cabotegravir CAB-LA in late 2021 which has the potential to decrease HIV transmission and increase PrEP adherence among TW The addition of CAB-LA to available PrEP options necessitates TW and PrEP service providers select the best method oral vs injectable for each TW However TW have unique concerns about PrEP eg interactions with gender-affirming hormones and report that patientprovider discussions on this medication are suboptimal Thus to inform this shared decision process the proposed study builds on formative work by developing and pilot-testing WePrEP a PrEP-focused bilingual digital shared decision-making tool SDMT tailored to diverse English- and Spanish-speaking TW and PrEP service providers WePrEP will support communication between TW and PrEP service providers as they identify the ideal PrEP product for each TW and discuss associated adherence strategies by cuing conversations on TWs unique PrEP needsconcerns and presenting pertinent information that is culturally relevant and tailored to this population To develop and test WePrEP the investigators will partner with the Mile High Behavioral Healthcare Transgender Center of the Rockies a Denver-based transgender-serving organization They will use McNulty et als adapted Shared Decision-Making Model for TW to guide the iterative participatory design process we will use with a group of raciallyethnically diverse TW and PrEP service providers to develop WePrEP we will begin this process using prototypes created from preliminary data Aim 1a The investigators will rigorously assess the usability of WePrEP via simulated patientprovider discussions Aim 1b Next they will pilot test WePrEP in a randomized controlled trial RCT N69 TW with 21 randomization In the RCT PrEP service providers N4 of which n1 is bilingual will use WePrEP with intervention TW to select CAB-LA or oral PrEP and discuss adherence Other providers N2 of which n1 is bilingual will give control TW a standard of care explanation of PrEP CDC recommendations to help them make their PrEP choice TW will be referred to Sheridan Health Services to start PrEP We will assess primary feasibility acceptability and secondary potential mechanisms of action of WePrEP preliminary impact outcome measures using validated scales and rigorous qualitative methods Aims 2 3 By creating a bilingual digital SDMT to enhance communication between TW and PrEP service providers as TW choose their ideal PrEP modality this project is likely to make a widespread and lasting impact on TWs uptake and adherence to PrEP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None