Exact(32)
Vaccine effectiveness was estimated as (1-OR) × 100% where the odds ratio of vaccination in cases vs test negative participants was estimated from a conditional logistic regression.
We controlled for the immunological changes associated with HIV infection by only including HIV negative participants in this study.
At the end of the study we found that two HBsAg –negative participants had been enrolled in violation of the protocol.
The strength of wanting to know their HIV status and the appeal of the free HIV test was equally strong among HIV-positive and –negative participants.
Proper evaluation of a screening test requires that the 'gold standard' test is applied to both test positive and test negative participants in the study.
Interviewing took place until redundancy was achieved, somewhat short of the original sampling targets (final sample included 18 HIV positive participants, 16 HIV negative participants).
Similar(28)
However, we did not include screen-negative participants in the validation study, so cannot determine the sensitivity of the screening question.
Some HIV-negative participants did acquire the virus for other reasons, such as from partners who hadn't achieved undetectability, or from people outside their relationship.
Baseline characteristics of HIV-positive and HIV-negative participants are shown in Table 1.
Only CMV-seropositive HIV-negative participants were included in the analyses of CMV-specific T cell responses.
Controls were stratified according to their PPD reactivity and grouped into subgroups of PPD-positive and PPD-negative participants.
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