Participant Accrual

Numbers that Matter 3476= total number of women enrolled at least 95% retention at each visit, at each study site 100% attention to data quality, safety Everything else flows from these…

Accrual Targets What is the overall accrual goal for ASPIRE? 3476 Initial accrual targets have been set for each site with the possibility of changing depending on performance and timelines.

Accrual Timeframe Begins on the date of first enrollment at the first site 12 month accrual period is approximate and will be adjusted, as necessary, to reach 3476 Management team will be in close communication with all sites as enrollment approaches target

Indicators to Evaluate Accrual Performance Screening and enrollment progress Monthly retention rates Protocol Deviations (number and type of deviations) PPD monitoring report and FHI 360 assessment visit findings Data quality statistics It’s not just about the numbers. quality It’s about quality.

Site presentation

Scenario #1: During a community meeting about the study, a male partner of a former VOICE participant wants to know why she would not be eligible for the ASPIRE study. – How will his question be addressed in this particular context/ audience? – How might this question be addressed with a potential participant in the clinic during the screening process?

Scenario #2: The site is planning to advertise enrollment in the study through different media. – What are the forms of media to advertise this study? – Are any approvals needed before the advertisement is released? If so, what are they? Who at your site is the person to ask? – Is the person developing the messaging the same person who will seek approvals (if needed). If not, how will this be communicated to them?

Scenario #3: The screening to enrollment ratio is unexpectedly high in the second month of study activation. – Who is responsible for tracking this? – How/ when is this communicated to the larger staff team? – What would be the next steps? Explain what would be reviewed and by whom. – Explain how this may or may not affect the site’s accrual targets.

Scenario #4: At month 3 of study activation, the retention rate at the site is 90%; screening to enrollment ratio is about 2:1 and the site will likely achieve the initial accrual target ahead of schedule; monthly QC rate is 9.6; and three instances of missed pelvic findings were discovered during a FHI 360 early assessment visit – How does your site know that this is the situation? – Are there any potential issues? If so, what does your site do to address the issues?

Scenario #5: List three recruitment strategies that worked particularly well for a previous study at your site. List three recruitment strategies that have not yet been implemented at your site. – Do you anticipate any challenges with the new or older recruitment strategies at your site? Explain why or why not.

Recruitment is always harder than expected!! Plan ahead Re-visit your strategies often Make adjustments as need Consult with the Protocol Team if there are any problems or issues SSP Section 4 – Accrual, Screening and Enrollment Who else can you contact for ideas on how to manage or refine your recruitment strategies?

What are your questions?