WCG Boosts Enrollment by 68%, Surpassing Sponsor Goals for RSV/HIV Study

CHALLENGE 

A sponsor partnered with WCG to offer recruitment support for a Phase III RSV/HIV vaccine study across 10 sites in South Africa. The recruitment process faced several hurdles including limited patient access to educational materials about the study, and the lingering stigma associated with HIV, all of which made it challenging to meet the enrollment targets within the desired timeframe.

Additionally, several sites were in rural regions of the country, where there was a generally low number of potential patients. Patients in these areas were often not educated about their disease, faced significant travel requirements, had varying literacy rates, and encountered other challenges.

SOLUTION 

WCG deployed 11 Clinical Research Coordinators (CRCs) prior to Site Initiation Visits (SIVs) to aid in start-up activities and pre-screening efforts for a Phase III study. Once enrollment opened, CRCs focused on chart review, community outreach, and establishing physician referral networks to identify all eligible patients in the local area. Initially, each CRC was allocated 24 hours per week.

WCG monitored enrollment rates and increased allocated hours or brought in additional CRCs as needed to ensure enrollment goals were met on time. Additional CRC support helped high-performing sites recruit more patients by alleviating the burden on site staff.

Early recruitment insights from CRCs and WCG’s Country Managers helped identify and address unique challenges sites were facing. Daily communication between the sponsor study team and WCG ensured smooth information flow on study progress, site insights, enrollment statistics, and timelines. Despite issues like site holds, unexpected site staff turnover, and shifting recruitment focus among gestational age groups, efficient communication kept all team members informed, and sites feeling well supported.

RESULTS

Collaboration between the sponsor and WCG yielded excellent results, with recruitment concluding on schedule. The study successfully enrolled 300+ participants, exceeding the sponsor’s target.

Notably, WCG’s CRCs were instrumental, directly contributing to the enrollment of 200+ participants, which accounted for 68% of total enrollments.

WCG TAILORED SUPPORT

1. Dedicated CRCs to work directly with study sites, enhancing participant identification and pre-screening efforts.
2. Experienced Project Management to optimize program execution within timelines and budget, and address challenges promptly.
3. Custom Site Services Management, which developed a client-specific, unified site engagement strategy. All training and monitored progress was visible through WCG’s My Patient™ portal.

LEVERAGING LOCAL EXPERTISE FOR TAILORED SOLUTIONS IN SOUTH AFRICA

The insights provided by our Country Managers proved to be invaluable in tackling early challenges and implementing effective solutions. Their expertise highlighted the influence of South Africa’s standard of care throughout pregnancy, helping us identify regions and demographics likely to yield qualified participants. They also underscored the significance of varying literacy rates, which necessitated the use of informational videos as crucial recruitment tools.

Additionally, the absence of classes and support groups for expecting mothers suggested that our community outreach strategies needed to be adapted uniquely for this region. These insights were critical in shaping our approach and ensuring the program’s success in a diverse and complex environment.