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Based on the number of births to African American women in Washington, DC, estimates of the number of women appearing at participating clinics in their first two trimesters of pregnancy, the prevalence of the risk factors estimated from previous studies, the estimated refusal rate, and the 2-year recruitment period, a total of 1,750 pregnant women were expected to enroll.
Because of the extent of poverty in the neighbourhood, as well as the nursing and support services offered through the study, the estimated refusal rate for participation in the study was under 10%.
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In the next step, we estimate refusal bias in HIV prevalence via a comparison of observed HIV prevalence estimates and predicted values generated by Heckman probit models that account for sample selection [ 32- 34].
A possible reason for this non-significant result may be the study power, as our initial sample size calculation did not allow for 25% of participants to refuse consideration of larval therapy (clinicians estimated 10% refusal rate).
Participation rates were not estimated and refusals were replaced by the next consenting women.
With an estimated rate of refusal of 20%%, 12 villagers were thus included per village.
We also estimated the likely refusal rates for admission as a result of inadequate capacity by assessing weaning unit bed availability on the day that a patient became eligible for admission to the weaning unit.
The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% CI 0.55 2.58, P=0.661).
Furthermore, we estimated a 40 50% refusal or dropout rate, based on a literature review of population studies.
An intention-to-treat analysis including all patients (and adjusting for baseline minimisation factors age and gender) gives an estimated odds ratio for refusal (intervention/no intervention) of 1.19 (P=0.661, 95% CI 0.55 2.58).
This study estimated the likelihood of refusal of PIHT in OPDs using: (1) HBM; (2) HBM-modifying contexts such as health motivation, psychosocial conditions in the health setting, and sociodemographic factors; (3) past behaviors, including experience of past similar behavior (HIV testing) and sexual behavior.
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