Data management and analyses
CRF
DISEASE, CRF
We will develop a case report form (CRF) that contains information needed for study visits. During the screening, we will collect data on the date of informed consent, demographics, disease and treatment, including current antiretroviral regimen and dosing schemes. Furthermore, the phone number of the participants and treatment supporters will be recorded. In follow-up visits, we will collect data about a change in the ARV regimen. In addition, we will collect information about pharmacy refills and self-reported adherence. Viral load will be measured and recorded at study entry and after follow-up. In addition, the infant of breastfeeding mothers will be tested for HIV according to standard care at week 6, month 9 and month 18. We will use Redcap®, an open-source database management system for randomization and data management. Data will be stored anonymously; whereby personal identifiers are stored on the participant screening log. The study’s data manager oversees all procedures considering data management and randomization. We will use intention-to-treat analyses comparing the two arms on the mentioned outcomes in each sub-study. We will also use intention-to-treat analyses comparing the two arms on the mentioned primary study outcomes. Therefore, we will use chi-square analyses to compare the percentage of women retained in care at 18 months and the percentage of children and adolescents having 95% adherence during the study period of 12 months. Also, we will do Student’s 