Trial results for a study evaluating the EMC2 PrEP Strategy for HIV prevention were posted on ClinicalTrials.gov on 2025-05-21, showing an increase in PrEP knowledge in the intervention group, though PrEP uptake remained at zero in both study arms.
Background
Pre-exposure prophylaxis (PrEP) is a highly effective method for preventing HIV infection. Despite its efficacy, challenges persist in PrEP awareness and uptake, particularly among cisgender women in primary care settings. Electronic Health Record (EHR)-based interventions represent a potential avenue to integrate PrEP education and facilitate its prescription within routine healthcare, aiming to bridge existing gaps in knowledge and access.
Trial design
This completed study, with no specified phase, enrolled 200 participants to investigate an Electronic Health Record-based approach, termed 'The EMC2 PrEP Strategy', designed to improve knowledge and uptake of PrEP among cisgender women in primary care. The study focused on participants with HIV Infections, utilizing Electronic Health Record systems within Primary Health Care settings. The intervention, 'The EMC2 PrEP Strategy', was compared against 'Usual Care' to assess its impact on various outcomes related to PrEP.
Key results
The trial results provided several key measurements comparing 'Usual Care' with 'The EMC2 PrEP Strategy':
- PrEP Uptake (Use): In both the 'Usual Care' group and 'The EMC2 PrEP Strategy' group, PrEP uptake was reported as 0 participants.
- PrEP Knowledge: Participants in the 'Usual Care' group had a mean PrEP knowledge score of 5.6 (Standard Deviation of 2.2). In contrast, participants receiving 'The EMC2 PrEP Strategy' showed a higher mean PrEP knowledge score of 7.5 (Standard Deviation of 2.5).
- Perceived Risk of HIV: The mean perceived risk of HIV was 19.2 (Standard Deviation of 5.2) in the 'Usual Care' group and 19.1 (Standard Deviation of 4.6) in 'The EMC2 PrEP Strategy' group.
- PrEP Attitudes: Mean PrEP attitudes were measured at 11.2 (Standard Deviation of 4.4) for 'Usual Care' and 10.5 (Standard Deviation of 3.9) for 'The EMC2 PrEP Strategy'.
- Health Literacy: Health literacy data was also collected, with 22 participants and 78 participants in the 'Usual Care' group, and 20 participants and 80 participants in 'The EMC2 PrEP Strategy' group.
What this means
The posted results indicate that 'The EMC2 PrEP Strategy', an EHR-based intervention, was effective in increasing PrEP knowledge among cisgender women in primary care, with a notable improvement in mean knowledge scores. However, this increase in knowledge did not translate into an increase in PrEP uptake, as zero participants in both the intervention and usual care groups initiated PrEP. Perceived risk of HIV remained largely similar between groups, and PrEP attitudes showed a slight decrease in the intervention arm. These findings suggest that while EHR-based strategies can enhance knowledge, other significant barriers beyond awareness may impede PrEP uptake in this population. Future interventions may need to address additional factors such as access, cost, stigma, or provider-patient communication to successfully convert increased knowledge into actual PrEP use.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05709860, titled "An Electronic Health Record-based Approach to Increase PrEP Knowledge and Uptake: the EMC2 PrEP Strategy", were posted on 2025-05-21 on clinicaltrials.gov.