WePrEP: Facilitating personal autonomy in HIV prevention through shared decision-making about PrEP for women in the US

University Of Colorado Denver, Aurora CO

Investigators

Abstract

ABSTRACT In the United States (US), women account for an estimated 19% of new HIV diagnoses. The best way to reduce HIV incidence in all people (including women) is to link them 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, increase PrEP adherence, and promote choice about HIV prevention for women. The addition of CAB-LA to available PrEP options necessitates women and PrEP service providers select the best method (oral vs injectable) for each person. However, women have unique concerns about PrEP (e.g., concerns about pregnancy/lactation) 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 women in the US and PrEP service providers. WePrEP will facilitate autonomy in HIV prevention choice by supporting communication between women and PrEP service providers as they identify their ideal PrEP product and discuss associated adherence strategies. This will occur by cuing conversations on women’s unique PrEP needs/concerns and presenting pertinent information that is relevant and appropriate. To develop and test WePrEP, we will partner with the Mile High Behavioral Healthcare, a Denver-based mental health and HIV prevention organization. We will use McNulty et al.’s adapted Shared Decision-Making Model to guide the iterative participatory design process we will use with a group of women and PrEP service providers to develop WePrEP; we will begin this process using prototypes created from preliminary data (Aim 1a). We will then rigorously assess the usability of WePrEP via simulated patient/provider discussions (Aim 1b). Next, we will pilot test WePrEP in a randomized controlled trial (RCT; N=69) with 2:1 randomization. In the RCT, PrEP service providers (N=4, of which n=1 is bilingual) will use WePrEP with intervention women to select CAB-LA or oral PrEP and discuss adherence. Other providers (N=2, of which n=1 is bilingual) will give control participants a standard of care explanation of PrEP (CDC recommendations) to help them make their PrEP choice. Women will be referred to Sheridan Health Services to start PrEP (if they wish; we acknowledge and respect that some participants will decide that PrEP is not right for them). 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 facilitate patient autonomy by enhancing communication between women and PrEP service providers as participants choose their ideal PrEP modality, our project is likely to make a widespread and lasting impact on uptake and adherence to PrEP, and HIV prevention independence. Our product is a rigorously designed, pilot-tested, bilingual, digital SDMT, suitable for use with all women in the US, that will test for efficacy in a larger, longer R01-funded RCT.