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All the investigators were trained on ISO-GCP standard before study start and on all study procedures during the site initiation visit by the sponsor.
During your PrEP initiation visit, the doctor will conduct various test including HIV; other STI tests; Hepatitis A,B,C; a metabolic panel; urinalysis; pregnancy test; and additional lab work, as needed.
The date of LTFU was recorded as the date of the most recent visit, or one day after ART initiation if patients only attended the initiation visit.
Every site is opened after a first initiation visit.
Among the deceased women, two already had AIDS-defining symptoms at HAART initiation visit.
All participating centres were personally trained and introduced into study-specific procedures during initiation visit.
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The treatment duration criterion for HIV patients was used to exclude patients who had just been initiated on ART, because initiation visits are very different from the follow-up visits and we intended to focus on the patient satisfaction with routine visits rather than with ART initiations.
For the purposes of this study, we assumed that all recorded doctor time represented initiation visits, and all recorded nurse and counselor time represented both the time spent during routine clinic visits and treatment initiation visits.
23 30 Two studies assessed the effect of extra involvement of trial coordinators with clinicians (extra communication; on-site initiation visits).
The second workshop focused upon good clinical practice requirements and applications to the study, the content of site initiation visits, and problem solving for potential recruitment and consenting issues.
In Table 1, CD4+ count seems to be higher in participants before HAART initiation than after HAART initiation, but it is noteworthy that some of the sicker individuals (low CD4+) who were treated did not have before HAART initiation visits included in the study.
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