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Table 1 Study objectives

From: The ring plus project: safety and acceptability of vaginal rings that protect women from unintended pregnancy

  Clinical trial Social science component
Primary objective To assess the impact on the vaginal microbiome of the use of a CVR intermittently (3 weeks followed by 1 week off) or continuously. To assess the level of acceptability and reported adherence to intermittent and continuous CVR use in women in Rwanda
Secondary objectives To assess the general safety of the CVR. To identify and describe the context specific attitudes and beliefs regarding family, family planning and gendered norms.
To assess the vaginal biofilm formation according to ring use regimen. To determine the presence or absence of a biofilm on the CVRs after intermittent or continuous use by visualization of the biofilm. To assess the impact of CVR on vaginal inflammation and immune activation according to ring use regimen.
Exploratory objectives   To explore the women’s beliefs and expectations regarding future potential use of a multi-purpose ring (contraception and HIV prevention). To explore how women and men in Rwanda perceive and experience risk related to unwanted pregnancy and HIV.