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.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Form 8 Two-Tier (High): Birth Visit Interview
Supporting Statement Part B 20100714.docx
Birth Visit July Launch VIS 20100607.pdf
Two-Tier (High): Birth Visit Interview