WePrEP: Developing a PrEP Shared Decision-making Tool for Transgender Women

Официальное название

WePrEP: A Bilingual Shared Decision-making Tool to Facilitate Conversations Between Transgender Women and Their Providers as They Select an Ideal PrEP Method

Обзор

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 (e.g., interactions with gender-affirming hormones) and report that patient/provider 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 TW's unique PrEP needs/concerns 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 al.'s adapted Shared Decision-Making Model for TW to guide the iterative participatory design process we will use with a group of racially/ethnically 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 patient/provider discussions (Aim 1b). Next, they will pilot test WePrEP in a randomized controlled trial (RCT; N=69 TW) with 2:1 randomization. In the RCT, PrEP service providers (N=4, of which n=1 is bilingual) will use WePrEP with intervention TW to select CAB-LA or oral PrEP and discuss adherence. Other providers (N=2, of which n=1 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 TW's uptake and adherence to PrEP.

Вмешательства

• Поведенческое WePrEP: A shared decision-making tool
  WePrEP will be bilingual, both patient- and provider-facing, stored on the provider's electronic device (and will have the capability to integrate with electronic health records in the future to enable scalability), and easily accessible during in-person or virtual patient-provider encounters. WePrEP is designed to present pertinent PrEP information to transgender women and their PrEP service providers to stimulate discussions about PrEP choice and support adherence (once a PrEP strategy has bee
• Поведенческое Active comparator: CDC recommendations for discussing PrEP
  Standard of care recommendations to discuss PrEP with potential end-users, endorsed by the CDC.

Первичные конечные точки

• Feasibility [Срок оценки: At enrollment]
• Acceptability [Срок оценки: At enrollment]

Вторичные конечные точки (10)

• Preliminary impact (1st of 3 measures) [Срок оценки: The proportion of transgender women who receive either form of PrEP is measured at enrollment.]
• Preliminary impact (2nd of 3 measures) [Срок оценки: For oral PrEP: PrEP serum concentrations are measured at 3 months. For injectable PrEP: PrEP serum concentrations are measured at 2 months.]
• Preliminary impact (3rd of 3 measures) [Срок оценки: For oral PrEP: PrEP refills are measured at 3 months. For injectable PrEP: Injections are measured at 2 months.]
• Mechanisms of action: Patient/provider communication (1st of 7 measures) [Срок оценки: Measured at enrollment]
• Mechanisms of action: Satisfaction with communication (2nd of 7 measures) [Срок оценки: Measured at enrollment]
• Mechanisms of action: Patient/provider engagement (3rd of 7 measures) [Срок оценки: Measured at enrollment]
• Mechanisms of action: Evidence of shared decision-making (4th of 7 measures) [Срок оценки: Measured at enrollment]
• Mechanisms of action: Satisfaction with control over PrEP decision (5th of 7 measures) [Срок оценки: Measured at enrollment]
• Mechanisms of action: Knowledge, motivation and self-efficacy to use PrEP (6th of 7 measures) [Срок оценки: Measured at enrollment]
• Mechanisms of action: Satisfaction with PrEP choice (7th of 7 measures) [Срок оценки: Measured at follow-up (for oral PrEP users, this is at 3 months; for injectable PrEP users, this is at 2 months)]

Критерии участия

Критерии включения

Eligible participants in the transgender women group (N=69) must:

• Self-identify as a transgender woman (e.g., was assigned male at birth, but currently reports a feminine gender identity)
• Be between the ages of 18 and 65
• Currently live in the Denver area
• Speak English or Spanish
• Be HIV-negative (via Alere Determine)
• Not have participated in the development of WePrEP
• Not currently take PrEP, but report they are "interested in doing more to protect themselves from HIV" \*\*We note that 1/3 of our RCT participants in the transgender women's group will be Black and/or Hispanic/Latina

Eligible participants in the PrEP service providers group (N=6) must:

• Not have participated in the development of WePrEP
• Live in the Denver area and (as a part of their employment responsibilities) discuss PrEP use with potential end-users.
• Have helped at least 1 TW make a decision about PrEP (e.g., whether or not to use it, which specific PrEP modality, etc...) in the last month.

Критерии исключения

Participants in the transgender women group are excluded if they:

• Currently live with HIV
• Do not meet one or more of the inclusion criteria above

Participants in the PrEP service providers group are excluded if they:

• Do not live in the Denver area
• Do not meet one or more of the inclusion criteria above

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Transgender Center of the Rockies — Sheridan

Идентификаторы

NCT: NCT06656676 · R34MH136932

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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