The Initial Vanguard Study protocol was designed to enroll approximately 1,750 pregnant women through seven study locations after 12 months of data collection. Two of the locations began recruitment in January 2009 and the remaining 5 in April 2009. As of May 2010, however, approximately 900 pregnant women have been enrolled, leading to questions about the assumptions underlying the Initial Vanguard Study recruitment model. The seven Initial Vanguard sites use a household enumeration and screening strategy to identify eligible women for recruitment into the study. Although household enumeration is often considered a gold standard for maximizing coverage, in that all dwelling units are identified and enumerated, for the NCS Initial Vanguard Study this method has not yielded the target number of births in the time frame projected from initial models. Consequently, additional methodological research is needed to evaluate the feasibility, acceptability, and cost of alternate recruitment strategies for enrollment of pregnant women into the NCS. This research will be conducted through the NCS Recruitment Substudy. The Recruitment Substudy will assess three alternate recruitment strategies - (1) a provider-based recruitment strategy; (2) an enhanced version of a household enumeration strategy; and (3) a two-tier recruitment strategy involving high-intensity and low-intensity data collection efforts.
The NCS Initial Vanguard Study, which consists of 7 Study locations, utilized the Household Enumeration and Screening Strategy, but did not yield the target number of births in the time frame projected from initial models. As a result, additional methodological research is needed to evaluate the feasibility, acceptability, and cost of alternate recruitment strategies for enrollment of pregnant women into the NCS. This research will be conducted through the NCS Recruitment Substudy. The Recruitment Substudy will assess three alternate recruitment strategies (1) a provider-based recruitment strategy; (2) an enhanced version of a household enumeration strategy; and (3) a two-tier recruitment strategy involving high-intensity and low-intensity data collection efforts.
Each recruitment approach would occur in 10 study locations, for a total of 30 study locations implementing alternate recruitment strategies. Recruitment strategies will be assessed and compared on the basis of feasibility (including success in recruiting and retaining sufficient numbers of participants), acceptability (including the extent of selection bias in recruitment, effect on respondent burden, and impact on study infrastructure), and cost. Ultimately, these comparisons will inform the recruitment approach or approaches to be taken for the NCS Main Study. Each recruitment strategy will be provided with approximately equally resources, and will be associated with a specific communications theme appropriate for its mode of participant enrollment.
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