Parent studies
Opt4Kids is an open-label, randomized controlled trial that examined the impact of POC VL testing in combination with targeted DRM testing and clinical decision guidance on VS among CLHIV on ART [Opt4Mamas is a prospective cohort study that compared VS rates pre- and post-implementation of a POC VL testing intervention among pregnant/postpartum WLHIV newly initiating or already on ART in the same five HIV treatment facilities. We enrolled 820 pregnant women during their antenatal care (ANC) visits and followed them for 6 months. During pre-intervention implementation, all enrolled women received SOC testing throughout pregnancy/postpartum care. During the post-intervention period, the study offered POC VL testing combined with targeted DRM testing and clinical decision guidance (as for Opt4Kids described above), and a new cohort of pregnant/postpartum women were enrolled to receive the intervention.For both studies, a Clinical Management Committee (CMC) was developed for intervention group patients modelled after, and including some members of, the existing MOH clinical management technical working group in Kisumu County. The CMC was comprised of the head of the Kisumu-based Technical Working Group, clinical providers from the five facilities, study personnel and lead investigators, HIV specialists from the MOH and other countries, and technical advisers from HIV implementing partners. The committee conducted case reviews using a standardized form prepared by facility staff. It convened on a regular basis to discuss cases and to provide recommendations about ART regimen changes and case management using a study-developed standardized form.