An electronic health record-based strategy to increase PrEP decision-making among cisgender women in primary care: results of a randomized pilot study

Background: Approximately one in five HIV infections in the United States occurs among cisgender women, those whose gender identity matches their sex assigned at birth. Pre-exposure prophylaxis (PrEP) is a highly effective preventive option for all genders, yet lack of awareness and stigma have hindered uptake. To address this gap, we sought to develop and pilot test an electronic health record-based strategy among cisgender women in primary care. Methods: Our strategy, informed by prior work, identified cisgender women in primary care who might benefit from PrEP, provided them with person-centered PrEP educational materials via the patient portal, and offered an opportunity to electronically request a dedicated PrEP visit with a PrEP champion – a female primary care physician – if desired. We conducted two sequential patient-randomized pilot studies to test: (1) the efficacy of the materials compared to usual care, and (2) the preliminary effectiveness of our strategy compared to usual care. The primary outcomes for the efficacy study included PrEP knowledge and PrEP stigma, while the primary outcome for the preliminary effectiveness study was PrEP uptake over a three-month period. Results: In total, we enrolled 200 women. The efficacy study (n = 100, n = 50 per arm) revealed our PrEP educational materials significantly increased PrEP knowledge scores among women who were directly shown the materials, compared to those who were not (9.4 (standard deviation (SD) 0.9) vs. 5.8 (SD 1.8) out of 10, p-value < 0.01, respectively). However, the preliminary effectiveness study (n = 100, n = 50 per arm) resulted in no significant differences, other than PrEP awareness, between women randomized to our strategy and those randomized to usual care. Conclusions: PrEP educational materials have the potential to increase PrEP knowledge among cisgender women. For the patient portal to be an effective delivery channel, additional support efforts should be considered. Trial registration: The study was registered at ClinicalTrials.Gov, Clinical Trial number NCT05709860 registered on 2023-01-17.