Human cytomegalovirus (CMV) is a leading cause of congenital infections worldwide.

A pharmaceutical client needed to better understand patient perspectives, concerns and awareness of that could impact the development of a vaccine for Human Cytomegalovirus (HCMV). The sponsor needed to understand:

• Patients’ knowledge about HCMV and congenital HCMV (cHCMV)
• How patients would value a vaccine that may not benefit their own health, but could possibly benefit the health of their future children
• Patient preferences and how they value participation in clinical trials for an investigative HCMV vaccine
• How patients prefer to learn more about these diseases
• The best ways to reach, educate and engage patients for clinical research
• Values and preferences regarding participating in clinical trials of an investigational vaccine for HCMV
• Preferred methods for learning more about these diseases
• Barriers and motivators to participate in a clinical trial
• The best ways to reach patients and educate them on clinical trials for HCMV.
• Effective ways to engage diverse patients

ICON developed and conducted two Patient Partner Workshops™, one for women without children and one for women with one or more children. Both cohorts were recruited to obtain a representative mix of potential recipients for a vaccine to prevent cHCMV. Workshop participants engaged in a variety of moderated activities designed to stimulate open, honest dialogue among the group. Topics and activities included:

• A quiz to assess knowledge of HCMV/cHCMV
• Discussion to understand participants’ plans, and concerns related to pregnancy
• Identification of reaction to HCMV/cHCMV after being provided with condition information
• An assessment participants’ willingness to receive HCMV vaccine and their reasons
• An assessment of participant knowledge of clinical trials, and any barriers and motivations for them to participate
• Assess participants’ willingness to receive HCMV vaccine and their reasons
• Assess participant knowledge of clinical trials, barriers and motivations to participate
• Both groups of women lacked awareness of HCMV and cHCMV
• Understanding health literacy and understanding of basic medical terminology was key to developing impactful messaging
• Participants with children were less concerned about the risk of HCMV than women without children; some women with children questioned the necessity of a vaccine. When women with children were asked if they would get the vaccine, half were undecided and half said they would not
• Most participants would not consult their partners while making a decision about the vaccine

The workshops revealed that both groups lacked awareness of HCMV and cHCMV. It was clear that patients needed a good level of health literacy and a basic understanding of medical terminology for disease related messaging to be most impactful.

The workshops uncovered differences and similarities between the two groups. Women with children were less concerned about the risk of HCMV than were women without children; some women with children questioned the necessity of a vaccine. When women with children were asked if they would get the vaccine, half were undecided and half said they would not. Most participants said they would not consult their partners while making a decision about the vaccine.

Based on the health literacy findings and insights generated by the workshops, the sponsor was able to develop and deliver a targeted disease awareness campaign and produce a range of materials to educate patients and their partners about HCMV and cHCMV. This included educational materials for study sites that incorporated patient focused lexicon and tone and updated outreach messaging to better resonate with and motivate study participants. Overall, the sponsor initiated strategies based on key workshop findings helped to reduce recruitment barriers and allow for successful retention of qualified patients.