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Recruitment, Enrolment and Retention into a South African TB Vaccine Trial

Recruitment, Enrolment and Retention into a South African TB Vaccine Trial. Beattie T 1 , Gardiner N 1 , Katsoulis L 1 , Bang P 2 , Hoff S 2 , Churchyard GJ 1,3 The Aurum Institute, South Africa Statens Serum Institut, Denmark School of Public Health, University of Witwatersrand.

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Recruitment, Enrolment and Retention into a South African TB Vaccine Trial

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  1. Recruitment, Enrolment and Retention into a South African TB Vaccine Trial Beattie T1, Gardiner N1, Katsoulis L1, Bang P2, Hoff S2, Churchyard GJ1,3 The Aurum Institute, South Africa Statens Serum Institut, Denmark School of Public Health, University of Witwatersrand

  2. Background • Regular review of recruitment, retention & enrolment data: • Optimise retention and enrolment rates • Identify operational challenges • Implement corrective strategies • Aim of this study: • Describe effective optimisation strategies

  3. Background • Phase II Double-blinded Placebo Controlled, Multi Center study to assess the Safety and Immunogenicity of an Adjuvanted sub-unit TB Vaccine Active South Africa Tembisa 5:1 Placebo Enrolled

  4. Recruitment, Screening and Enrolment

  5. Strategies: • Implemented at Study Start (December 2011): • Contact HIV-infected persons identified through Aurum HIV outreach campaigns.

  6. Strategies: • Implemented in February 2012 (Sub-optimal enrolment rate) • Continuous referral of HIV-positive from mobile Aurum HIV VCT teams • Daily review of recruitment numbers for potential screening • Restricting eligibility for enrolment assessment to the experienced PI.

  7. Results • Avg rates: • Scr: 8.25/week • Enr: 1.85/week • Scr rates: • 4.75 < 3 Feb • 12.2 > 3 Feb • Factor = 2.6X

  8. Results: Failure Code

  9. Results • Avg rates: • Scr: 8.25/week • Enr: 1.85/week • Scr rates: • 4.75 < 3 Feb • 12.2 > 3 Feb • Factor = 2.6X • Enr rates: • 1.0 < 24 Feb • 4.3 > 24 Feb • Factor = 4.3X 3 weeks

  10. Retention

  11. Strategies: • Implemented: At Study Start (December 2011): • Issuing diary cards at enrolment • Verifying contact information • Obtain 3 telephone numbers • Verify contacts by enquiring if they know the participant. • Issuing telephonic reminders

  12. Results • Number of completed visits expressed as a % of total expected visits, per study time point / visit: • % Participants completing the trial: • 95% (23/24) % Completed Visits % Visit Number

  13. Conclusion • Regular review of trial data is needed to implement corrective strategies early. • Effective enrolment and retention rate optimisation strategies: • Referral of HIV-positive from mobile HIV VCT teams • Daily review of recruitment numbers for potential screening • Eligibility assessment limited to PI. • Issuing telephonic reminders • Verifying contact information • Issuing diary cards at enrolment

  14. QUESTIONS?

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